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Medical Research

  • Big Data Strategies for Cell Therapy Manufacturing
    Big Data Strategies for Cell Therapy Manufacturing
    Scott R. Burger, MD, Principal of Advanced Cell & Gene Therapy, LLC and Heidi Hagen, Co-founder and CSO for Vineti Inc Recorded: Sep 17 2019 76 mins
    The quest to retrieve, analyze, and leverage that data has become the new gold rush in life sciences. This presentation will discuss the role of big data in cell therapy process development, real time analytics and commercial scale manufacturing.
  • Biopharmaceutical process development – Trends/ Challenges/Opportunities
    Biopharmaceutical process development – Trends/ Challenges/Opportunities
    Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd Nov 20 2019 9:30 am UTC 90 mins
    Current trends and regulation affecting Biopharmaceutical Industry
    Journey from Lab scale to Commercial –Overcoming Scalability design hurdles
    QbD-Bringing Improvements in Biologics development and Manufacturing Space
  • Alternative And Rapid Microbiological Methods: Microbiology Of The 21st Century
    Alternative And Rapid Microbiological Methods: Microbiology Of The 21st Century
    Dr Benoit Ramond, Head of Microbiology & Sterile Technology, Sanofi and Dr David Jones, Director at Rapid Micro Biosystems Recorded: Sep 12 2019 77 mins
    Today Pharmaceutical industry remains conservative for microbiology testing methods and has reluctance to develop and to use Alternative and Rapid Microbiological Methods (RMM) supported by a number of misunderstandings and prejudgments based on the following myths:
    - RMM are not accepted by regulation authorities,
    - RMM will never replace classical microbial methods,
    - RMM will not offer return on investment (ROI),
    - Data generated from RMMs will exceed current specifications and limits involving increase in batch rejections.

    Nevertheless a movement is in progress for the use of new technologies and systems because classical microbial methods, in spite of their long return of experiences and their confidence for the regulatory point of view, have a number of disadvantages such as:

    - Time to results in days to weeks,
    - Results vary with microbial population, media, culture conditions,
    - Lack of reactivity in case of exceeding limit results,
    - Sensitivity could be insufficient giving underestimations in the contamination risk,
    - Existence of confluent growth.

    This webinar provides an overview of the current situation about RMM technologies, regulatory expectations, it proposes some initiatives facilitating the implementation of RMM including a strategy for validation and it gives a projection for the perspectives of the RMMs for the future.
  • Sanofi’s and SGS’S Implementation of BPOG’S Leachable Risk Assessment model...
    Sanofi’s and SGS’S Implementation of BPOG’S Leachable Risk Assessment model...
    Ken Wong, Deputy Director at Sanofi Pasteur and Dujuan Lu, Manager/Global Lead of Extractables & Leachables at SGS Recorded: Sep 10 2019 89 mins
    Full Title: Case Study and Experience on Sanofi's and SGS's Implementation of BPOG's Leachable Risk Assessment Model and Extractable Testing Protocol

    Presented by Ken Wong, Deputy Director at Sanofi Pasteur

    Brief review of the BPOG's Leachable Risk Ranking model. A case study of the leachable risk model implementation into Sanofi will be presented. All changes to specific risk factors and weights changes will be discussed. Finally, the lesson learns and experiences of the risk model performances on several projects will be shared.

    Followed by Case Study and Experience in Extractables and Leachable Studies of Plastic Process Materials – a CRO perspective

    Presented by Dujuan Lu, Manager/Global Lead Extractables & Leachables at SGS Life Sciences

    Extractables and leachables (E&L) from the plastic process materials used during pharmaceutical and biopharmaceutical manufacturing can potentially pose risks to the safety, efficacy, and stability of pharmaceutical and biopharmaceutical products.
    The USP risk assessment model will be briefly reviewed. Challenges regarding design of extractions and analytical evaluation threshold (AET) calculation for process materials will be discussed. A few case studies regarding the E&L studies of process materials will be shared.
  • Tutorial for a better understanding of HILIC
    Tutorial for a better understanding of HILIC
    Dr. Frank Michel, Analytical & Chromatography Scientific Advisor, Merck KGaA Darmstadt, Germany Recorded: Sep 10 2019 5 mins
    Interest in chromatography using hydrophilic interaction liquid chromatography (HILIC) has continued to build in recent years. Although HILIC chromatography is known to provide valuable retention and selectivity of polar compounds and provide highly compatible conditions for coupling with mass spectrometry, it is sometimes avoided due to issues surrounding robustness and repeatability. In this webinar stationary and mobile phase selection will be discussed in detail together with the impact of sample solvent and equilibration procedures on retention times. Based on this HILIC method development practices can be improve and better understanding of HILIC is gained.
  • The Journey to Lean Implementation for Efficiency Increase
    The Journey to Lean Implementation for Efficiency Increase
    Uwe Voelker, Site Head, Sterile Drug Product Manufacturing at Roche Recorded: Sep 4 2019 43 mins
    Adoption of strategic and systematic use of lean principles to improve operational efficiencies and cost competitiveness
    Systematic reduction of waste, complexity and variability,
    Reduction of order lead time,
    Higher employee satisfaction and engagement tackling the cultural challenges
    Achieving speed and reliability in the manufacturing value chain.

    Presented by Uwe Voelker, Site Head, Sterile Drug Product Manufacturing at Roche

    Uwe Voelker is currently the Site Head (GM) at Roche in Mannheim, leading Pharma Operations (Biologics DP site). He was previously in VP-roles in both Quality and Techn. Operations, local and global roles, a.o. Head of Global Quality Small Molecules, Site Head in a Biologics DP site in Switzerland.
    Uwe is well versed in all aspects of Quality Management; Lean, Operational Excellence and Change management.
  • Innovative contracting in Europe – a Trojan horse?
    Innovative contracting in Europe – a Trojan horse?
    Smita Sealey and Barry Farimond, ZS Associates, Malcolm Qualie, NHS England, Alain Boulanger, Filippo Drago Recorded: Sep 2 2019 64 mins
    Overview

    With pricing of drugs at the centre of political and social debate, the market access and pricing environment in Europe has become increasingly challenging over the years. Innovative contracting has since become a common route to overcome these challenges and ensure timely access for patients.


    Focus

    Join us on Monday 2nd September from 15:00-16:00 BST as we discuss the future of innovative contracting with our panel of European payers. Key topics to be covered include:

    To what extent and how contracting helps improve patient access?
    What prior successes and failures can teach us about designing contracts that deliver true value to the health systems?
    Can we avoid contracting and what would be the alternative?

    In the past decade, we have moved from simple discounting and traditional volume-based agreements to more complex value-based models involving measurement of health outcomes, risk-sharing and cost containment guarantees. The feasibility of these contracts tends to vary by EU market, dependent mainly on the available healthcare system infrastructure to collect and process data as well as other regulatory and philosophical differences.

    Ultimately, the question remains as to whether these agreements are a move towards better healthcare provision and more connected healthcare infrastructures, or are they slowing down access and creating administrative burden due to their complexity?
  • Beyond Purely Data-Driven Approaches for Efficient Knowledge Management in Proce
    Beyond Purely Data-Driven Approaches for Efficient Knowledge Management in Proce
    Moritz von Stosch of GlaxoSmithKline Vaccines Followed by Klaus Mauch and Shilpa Nargund of Insilico Biotechnology AG Recorded: Sep 2 2019 84 mins
    Title: Beyond Purely Data-Driven Approaches for Efficient Knowledge Management in Process Development

    Knowledge from first principles is freely available and generally valid, and when integrated along with Artificial Intelligence (data-driven) methods, it can greatly improve the understanding and applicability. The applications of such an approach, referred to as hybrid modelling, to a fermentation and controlled drug release case are presented and the learnings from the development of these models are shared.
  • Famous Cancers
    Famous Cancers
    Nicole Lewis Recorded: Aug 27 2019 65 mins
    It’s no secret that we live in a celebrity centric culture hungry for the latest news about our favorite famous faces. This lecture will employ the fascinating world of celebrities to introduce the immunohistochemical grid approach to cancer disease states. We will specifically use cancer stories from past and present entertainers, athletes, and politicians to examine the histological characteristics and statistics that define various tumor types. These cases will also be our launching pad as we take a deep dive into the intricate world of tumor immunophenotyping by highlighting recent antibody additions and their impact on modern detection. Attendees will learn the utility of these new antibodies and gain a better overall understating of how diagnostic grids are used by pathologists to provide thorough and accurate patient care.
  • What can we learn from radiosurgery platform comparison studies?
    What can we learn from radiosurgery platform comparison studies?
    Ian Paddick Recorded: Aug 22 2019 61 mins
    Various SRS treatment platforms are available, and there has been an increasing number of platform-comparison studies in recent years, but most of these are limited to single-centre studies. The recently published NHS England study, a national commissioning programme benchmarking different planning cases to evaluate current practices across clinical centres treating SRS cases for benign brain tumours and metastases, will be reviewed in detail during the webinar. Bias is common, due to various study flaws, including comparison of non-contemporary equipment, unequal expertise and comparison of plans created in a clinical versus study environment.

    However, this NHS study, arguably the "study to end all studies", provides a unique dataset of current practice across a large number of providers and equipment platforms.
  • A guide to biotechnology commercialisation
    A guide to biotechnology commercialisation
    Pete Hotten Recorded: Aug 20 2019 43 mins
    Over the past century, life sciences has exploded with innovation and it continues to promise excellent commercial opportunities for those with scientific and academic research in this area. However, research on its own is not enough for these discoveries and inventions to reach their commercial potential. With over thirty years' experience in the biotechnology sector, expert Pete Hotten provides a framework for commercialisation, what to look out for in market research and how evaluating the competition can help determine next best steps.
  • Mixed mode Chromatography in Purifying biologics - Overview
    Mixed mode Chromatography in Purifying biologics - Overview
    Vivek Halan Zumutor Biologics Pvt Ltd, Bangalore, India Recorded: Aug 20 2019 41 mins
    This Webinar will discuss MMC in purifying biologics which includes monoclonal antibodies (mAbs), Bispecific antibodies (BsAbs), antibody fragments (Scfv,Fab) and other recombinant proåteins. My discussion is intended for audience from biopharmaceutical industry as well as active collaborators from academic institutes.
  • Sepsis Overview: Challenges and Solutions for Laboratories
    Sepsis Overview: Challenges and Solutions for Laboratories
    Mirta Gamez, M.T.(A.S.C.P.), C.L.S. Recorded: Aug 16 2019 51 mins
    Sepsis presents a global healthcare crisis, with more people dying from sepsis than from prostate cancer, colon cancer, breast cancer and AIDS combined.(1,2) Early intervention is critical, and the clinical laboratory plays a crucial role in early detection.

    View this on-demand webinar to hear Mirta Gamez, MT(ASCP), CLS, explore the laboratory’s role in clinical sepsis diagnosis and treatment.

    After attending this webinar, you will be able to:
    -Articulate the basic etiology of sepsis and its impact on healthcare
    -Identify the challenges that affect the rapid diagnosis of sepsis
    -Guide how—and when—common sepsis biomarkers are used for detection and monitoring
    -Advise on the role of the laboratory in sepsis diagnosis and management

    P.A.C.E. credit is available for your participation.*

    (1)Kumar G A et al. “Nationwide Trends of Severe Sepsis in the twenty First Century (2000-2007). Chest, 2011;16:1223–1231. doi: 10.1378/chest.11-0352.
    (2)Hall MJ, Williams SJ, DeFrances CJ, Golosinsky A. “Inpatient Care for Septicemia or Sepsis: a Challenge for Patients and Hospitals.” Accessed on http://www.cdc.gov/nchs/data/databriefs/db62.pdf Apr 16, 2019.

    *Beckman Coulter Inc. is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. These credits are recognized by the State of California. At this time, we cannot issue continuing education credits for those who provide healthcare (or work for an institution that provides healthcare) in Massachusetts or Vermont.
  • Cell Culture Fundamentals
    Cell Culture Fundamentals
    Kyung-A (Katie) Song, Ph.D. Recorded: Aug 15 2019 44 mins
    Cell culture is a fundamental technique for a variety of applications. Cells are cultured in controlled conditions including temperature, gas exchange, pH, and culture media (energy and nutrients). This webinar will introduce basic concepts of cell culture and provide tips on how to succeed in culturing mammalian cells.

    In this webinar, we will review:
    •Introduction to cell culture
    •Critical factors for successful cell culture
    •Cell culture tips and techniques

    Presenter Bio:

    Dr. Kyung-A Song graduated from Sungkyunkwan University with a Ph.D. in molecular biology and cancer immunology. She completed her postdoctoral fellowship in pharmaceutical research and drug discovery at Virginia Commonwealth University. She has extensive experience in a variety of cell culture techniques including isolation and culture of primary patient cells. She has worked with xenograft models and many cancer cell lines, and she has expertise in in vitro cell based functional assays and in vivo experiments. She is currently a Scientific Support Specialist for Corning Life Sciences where she answers customer inquiries about all products in the extensive Corning Life Sciences product portfolio.
  • Determinación de macro y micronutrientes
    Determinación de macro y micronutrientes
    Omar Ruiz Sotelo,Field Marketing Specialist, Merck KGaaA Darmstadt Germany Recorded: Aug 13 2019 44 mins
    Aplicaciones para agricultura, acuacultura y agua de mar a través del Método fotométrico.
  • Mapping Future Technology Needs For Real Time Release Testing
    Mapping Future Technology Needs For Real Time Release Testing
    Dr Udayanath Aich, Associate Director at Bristol-Myers Squibb Recorded: Aug 9 2019 52 mins
    Real time monitoring and in-time release of products create a demand to move testing from QC release (off-line) analysis to the manufacturing shop floor (in-line, on-line or at-line monitoring), in order to address Biopharmaceutical manufacturing goals of reducing speed, cost and maximizing quality of product. BioPhorum Operations Group (BPOG) published a Biomanufacturing Technology Roadmap in July 2017 with the active collaboration of Biopharma industry representatives and supply partners. As part of implementation of roadmap strategy, BPOG’s ILM-RTR technical forum team is developing User Requirement Specifications (URS) for prioritized CQA’s and CPP focusing on the critical control points and future requirements of real time release (RTR). The URS documents will promote effective development of desired Short, Mid and Long term technologies by the innovators and supply partners.

    Presented by Dr. Udayanath Aich Associate Director at Bristol-Myers Squibb

    Dr. Udayanath Aich has an extensive experience and management skills in analytical chemistry, and CMC analytical strategies for early, late and commercial biologics products. He then decided to move to M.I.T to gain extensive skills in the area of Biopharmaceutical characterization and drug development. Dr. Aich joined at Thermo Fisher Scientific in the chromatographic and mass spectrometric division to broaden his extensive analytical skills. Then Dr. Aich worked as Investigator at GlaxoSmithKline in the area of protein and glycans characterization, process analytics, CMC analytical strategies as ATL and structure-function study. Finally, before joining at Bristol Myers Squibb, Uday was working at Sanofi related to high throughput technologies, process analytical technologies (PAT), Analytical method harmonization, multi-attribute method Dev, analytical method dev, robustness, qualification and transfer for early and late stage product including 2nd generation commercial product as part of life-cycle analytics.
  • Bioburden Control within Continuous Manufacturing
    Bioburden Control within Continuous Manufacturing
    Britta Manser, Manager EU SLS Continuous Bioprocessing for Pall Corporation Recorded: Aug 7 2019 4 mins
    Bioburden control within continuous manufacturing

    Bioburden control within continuous manufacturing is a key area of concern in the biotech industry. In this short video from Pall Biotech, Britta Manser outlines how existing technologies can help mitigate potential risks linked to bioburden control among new technologies.

    Do you like the idea of producing 100 g of your mAb product every day? This is now possible using a continuous processing platform. Download a brochure to discover how.

    http://go.pall.com/brochure-continuousbioprocessing.html?utm_source=biopharma-asia&utm_medium=link&utm_campaign=19-03-121-ISCON&utm_content=brochure
  • Achieving clinical end-to-end accuracy for confident intracranial SRS treatment
    Achieving clinical end-to-end accuracy for confident intracranial SRS treatment
    Daniel L Saenz and Emmanouil Zoros Recorded: Jul 30 2019 59 mins
    This webinar will share the results of a stereotactic end-to-end accuracy evaluation of the Elekta Versa HD HDRS linac across a six-site consortium. An RTsafe PseudoPatient 3D gel phantom was used to demonstrate SRS treatment accuracy and delivery confidence with a single isocenter VMAT technique to treat multiple brain metastasis. This technology allows the direct comparison of planned versus delivered dose to evaluate system end-to-end accuracy and compare results between participating institutions.
  • Designing production facilities of the future
    Designing production facilities of the future
    Geoffrey Hodge, Chief Technical Officer at Unum Therapeutics and Gary Pigeau, Ph.D., Director at GE Healthcare Recorded: Jul 30 2019 87 mins
    Engineered autologous T cell products have proven to be an extremely promising new therapeutic modality, but they are currently time-consuming and costly to manufacture. This presentation will review the history of biotherapeutics development to look for lessons we can learn that may accelerate advances in autologous cell therapy manufacturing. It will also highlight the differences between traditional biotherapeutics manufacture and autologous cell manufacture to identify areas which may require us to look to other industries for inspiration. Finally, it will present an integrated vision for an autologous cell therapy manufacturing facility of the future which incorporates current initiatives, lessons from the past, and ideas from other industries to improve the robustness, cost, and time of autologous cell therapy manufacture.

    Followed by Enterprise solutions for cell and gene therapy

    The cell and gene therapy industry is growing at a rapid pace, with more and more attention on manufacturing rigor and scalability. Solutions are needed to achieve these outcomes while providing the speed and agility to succeed in this dynamic space. To tackle these issues and make life-saving therapies more accessible, the industry needs a new way of thinking. This presentation will discuss approaches that can be applied in modular fashion to create a customized production facility with the flexibility to evolve over time.

    Modern facilities include integrated technologies that close and automate processing, delivering the scalability and control lacking in typical manual workflows. An integrated platform can be housed inside a prefabricated structure – a cleanroom or a larger manufacturing facility. Both options allow for quick addition of GMP manufacturing capacity without interrupting existing work. A manufacturing execution system can be added to bring facilities together with cloud-based oversight of what is happening in real time.
  • Cybersecurity in Healthcare: 3 Ways Organizations Can Mitigate Security Risks
    Cybersecurity in Healthcare: 3 Ways Organizations Can Mitigate Security Risks
    Mike Jude, Ph.D., Research Manager, Frost & Sullivan, Erin Benson, Director, Market Planning, LexisNexis Risk Solutions Recorded: Jul 25 2019 50 mins
    What is complicating healthcare cybersecurity?

    Solution providers need to articulate their value proposition, not only in business terms, but also in terms of the impact their technology will have on the delivery of healthcare and, ultimately, the wellbeing of the patient.

    Key Takeaways:

    • Identify primary barriers to establishing excellent healthcare cybersecurity.
    • What impact will IoT and cloud services, including computing and storage, have on healthcare cybersecurity?
    • What are the substantial growth opportunities?
  • How pharma marketing can stay ahead of the evolving customer journey
    How pharma marketing can stay ahead of the evolving customer journey
    Robb DeFilippis, Managing Director, Life Sciences, Tag, Steve Pitts, Business Director, Tag, Dominic Tyer, pharmaphorum Recorded: Jul 23 2019 64 mins
    Overview
    Join our live webinar taking place on Tuesday 23rd July at 16:00 BST / 11:00 EST / 08:00 PST.

    Customer journeys in pharma are changing, with important implications for the marketing supply chain. How can pharmaceutical marketers capitalise on this trend and free up budget to invest in additional marketing channels?

    Focus
    New developments in data and digital are changing traditional customer journeys and forcing pharmaceutical companies to evolve in order to keep up.

    Companies like Apple and Amazon have elevated customer expectations for personalised content and interactions across multiple channels, in the process setting new standards for marketing. But, as they push the envelope, what are the implications for pharma’s work in customer engagement?

    This pharmaphorum webinar, in association with Tag, will examine the challenges that pharma marketing faces to stay ahead of the evolving customer journey and offer expert insight from both the pharma and FMCG sectors on how to convert these challenges into opportunities .

    The expert panel will consider exclusive research carried out by Tag and pharmaphorum across the US, Europe and Asia-Pacific among senior decision-makers in pharma and FMCG marketing.

    The webinar, which takes place on Tuesday 23rd July at 16:00 BST / 11:00 EST / 08:00 PST will also look at:
    •How pharma currently allocates its marketing budgets
    •Where marketers would like to have more money to invest
    •How much time is spent directing creative ideation and managing marketing production

    For more information, please visit:
    https://pharmaphorum.com/digital/how-pharma-marketing-can-stay-ahead-of-the-evolving-customer-journey/
  • Innovation Strategy: How to start a start-up
    Innovation Strategy: How to start a start-up
    Joe Sekhon Recorded: Jul 17 2019 46 mins
    In this webinar, senior IP lecturer and distinguished start-up mentor, Joe Sekhon, will take us through his proven framework for giving ideas the best chance of success.
  • Use of Computational Modelling in Specification Setting and Establishing Control
    Use of Computational Modelling in Specification Setting and Establishing Control
    Thomas O'Connor, Scientist at FDA and Sean Bermingham, Head of Formulated Products at PSE Ltd Recorded: Jul 15 2019 77 mins
    Full Title: Use of Computational Modelling in Specification Setting and Establishing Control Strategy

    The proportion of scientific evidence supporting medical product regulatory applications derived from modeling and simulation studies is expected to continue to grow into the future. In the Quality by Design framework, mathematical models can and have be utilized at every stage of product development and manufacturing. Thus, the regulatory assessment of product quality models is not unprecedented but the frequency, types of models, and applications are evolving. This evolution is being driven in part by the adoption of advanced manufacturing such as continuous pharmaceutical manufacturing.

    The ICH Quality Implementation Working Group points to consider document categorizes models based on the model’s contribution in assuring the quality of the product. Models utilized as part of the control strategy are typically categorized as either high or medium impact depending on the role of the model. Minimal guidance though is provided on model validation. A recent standard (ASME V&V 40) outlines a process for making risk-informed determinations as to whether a model is credible for decision-making for a specified context of use. The presentation will discuss how the framework could be used to develop model validation plans and support regulatory assessment using case studies from both drug substance and drug product manufacturing.
  • IP Strategy: Tackling Open Source Software
    IP Strategy: Tackling Open Source Software
    Martin Callinan, Source Code Control Recorded: Jul 10 2019 42 mins
    In this webinar, we'll dive into the latest developments in managing Open Source Software as part of your IP strategy. The webinar will review recent changes in the world of Open Source Software, including highlights of the 2019 Open Source Security and Risk Survey. There will be an assessment of the changing dynamic, using the example of Soundview. The webinar will cover advice on how to manage Openchain, which is on track to be a ISO Standard within 12 months. Additionally, this webinar will investigate the new PCI software lifecycle with an example of how to manage this on an ongoing basis – the process and the tools.
  • Chemical and Physical Transformation Monitoring by Raman and IR Spectroscopies
    Chemical and Physical Transformation Monitoring by Raman and IR Spectroscopies
    John Wasylyk, Sr Principal Scientist at BMS and Karen Esmonde-White, Senior Marcom Specialist at Kaiser Optical Systems Inc Recorded: Jul 1 2019 63 mins
    During the lengthy process of pharmaceutical development, an Active Pharmaceutical Ingredient (API) or its intermediates can go through many physical and chemical changes. These changes are needed to produce the API with the correct chemical structure and physical property. Monitoring the progress of these transformations is important for the process understanding as well as serving as a tool for in-process control (IPC) to ensure the completeness of the transformation. IR and Raman Spectroscopies are sensitive to both chemical and physical changes of a compound and have evolved into useful tools in our lab for monitoring both chemical and physical transformations. They can be used to monitor the progress of the chemical reaction leading to the desired product, the slurry-to-slurry form transformation leading to the desired crystalline form, and the instability of API leading to undesired degradant. When used in-line, they can also be used to study the kinetics of a chemical reaction as well as the rate of crystalline form conversion...

    Followed by Utility of Raman spectroscopy in continuous processing of liquids and solids

    An important consideration in successful continuous manufacturing is integrating analytical tools into the flow. In batch reaction monitoring, on-line and at-line analyses enable Quality by Design (QbD) and ensure stable operations. Intense reaction conditions, non-traditional chemistries, high throughput and speeds, and miniaturized reactors are challenging environments for analytical tools originally developed for batch reaction monitoring. We present process Raman technologies adapted for continuous manufacturing processes in liquids and solids. Over the last 20 years, Raman spectroscopy has become an established technique for process monitoring and control, with applications in continuous manufacturing of liquids and solids...
  • From Concept to Market – Unique approaches in Biomanufacturing
    From Concept to Market – Unique approaches in Biomanufacturing
    Jincai Li, Vice President of WuXi Biologics Kevin Mullen, Sr. Product Manager, Single-Use Systems at Thermo Fisher Scientific Sep 18 2019 7:00 am UTC 90 mins
    Presented by Dr. Jincai Li, Vice President of WuXi Biologics

    With the rapid growth of the biotherapeutics industry, the need and challenge for high quality, cost efficient production has been increasing as well. At the same time, the number of approved biologics products are also steadily increasing, and more and more products are being developed by small to mid-size biotech companies, with product market size that vary greatly and therefore leading to varying production scale needs. The presentation will talk about the paradigm shifts in today’s facility design and operations, with multi-purpose facility and smaller, modular facility being favored by many companies. In addition, rapid adoption of disposable technology has enabled faster and lower cost facility design & start-up. With the modular, disposable technologies, the unique “scale-out” approach has the advantage of providing highest flexibility to customers while simultaneously lowering tech transfer and scale-up risks. The presentation will also cover the continuous bioprocessing concept and share WuXi’s efforts on this area.

    Followed by a presentation by Kevin Mullen, Sr. Product Manager, Single-Use Systems at Thermo Fisher Scientific
  • How to Utilize Design of Experiments (DoE) Principles for the Development of...
    How to Utilize Design of Experiments (DoE) Principles for the Development of...
    Jeremy Springall PhD, Scientist II, Analytical Sciences, R&D Biopharmaceutical Development, AstraZeneca Sep 19 2019 2:00 pm UTC 90 mins
    Full Title: How to Utilize Design of Experiments (DoE) Principles for the Development of High Throughput, Robust Methods for the Assessment of Product Quality

    Being able to generate accurate and precise analytical data to provide information on product quality in a timely manner is a great challenge facing analytical groups. By adopting a Design of Experiments (DoE) approach, we can overcome many hurdles facing the implementation and adoption of these high-throughput chromatography methods with the data generated being of comparable quality to that from longer lot release methods.

    Presented by Jeremy Springall PhD, Scientist II, Analytical Sciences, R&D Biopharmaceutical Development, AstraZeneca

    Jeremy Springall has worked in the Analytical Sciences group, part of R&D Biopharmaceutical Development, at AstraZeneca for the past five years. His responsibilities include assess new technologies and work processes to support early and late stage development assets as well as being a CMC analytical team lead on several non-mAb projects currently in the AstraZeneca development pipeline. Previous roles include In-process analytical development scientist at UCB and analytical development scientist at Patheon, both in the UK. He holds a Ph.D. in bioorganic and medicinal chemistry and a BSc in chemistry from the University of Bath, UK.
  • Characterization of Biotherapeutics
    Characterization of Biotherapeutics
    Diane McCarthy, PhD, Senior Scientific Liaison, US Pharmacopeia and Kai Scheffler Product Manager at Thermo Fisher Scientific Sep 24 2019 2:00 pm UTC 90 mins
    By Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia

    Biotherapeutic products are typically characterized by multiple orthogonal methods to evaluate product quality and purity, including assessment of aggregates, variants, and degradation products. For monoclonal antibodies and many other biotherapeutics, analysis of post-translational modifications, such as glycosylation, are also important since these modifications can impact the efficacy, stability, and safety of the final product. This presentation will provide an overview of methods and standards used during characterization, with an emphasis on monoclonal antibodies.

    Followed by Charge Variant Separation Coupled to High Resolution Mass Spectrometry for Routine mAb Analysis

    By Dr Kai Scheffler, Product Manager at Thermo Fisher Scientific

    Biotherapeutics such as monoclonal antibodies are a heterogeneous mixture of structurally similar molecules that differ in mass and charge, referred to as charge variants. Charge variants result from sequence variations and post-translational modifications such as e.g. deamidation and sialylation resulting in species that are more basic or acidic than the main mAb monomer. The heterogeneity can be revealed by charge-sensitive separation methods, such as ion exchange chromatography. The use of MS-compatible buffers allows for online hyphenation to a mass spectrometer. This hyphenated setup provides the chromatographic resolution of ion exchange chromatography coupled to the identification of the separated variants by mass spectrometry.
    In this webinar we will discuss a charge variant analysis (CVA) workflow that entails ion exchange chromatography using pH gradients for protein elution with online mass detection on a high resolution Orbitrap-based mass spectrometer. This workflow enables routine application to a wide range of antibody samples for comprehensive analysis based on a single injection without the need for sample preparation.
  • Fast GC - Background, Theory and implementation in the lab
    Fast GC - Background, Theory and implementation in the lab
    Dr. Frank Michel, Analytical & Chromatography Scientific Advisor, Merck KGaA Darmstadt, Germany Sep 25 2019 6:00 am UTC 75 mins
    The approach of Fast GC is becoming more and more popular, because it can vastly increase sample throughput and improve laboratory efficiency in routine analytical laboratories. This webinar will address the theoretical background, practical aspects and considerations to implement this technique in any GC lab.
  • Implementation Of An Affordable & Scalable Manufacturing Strategy
    Implementation Of An Affordable & Scalable Manufacturing Strategy
    Bastiaan Leewis of MeiraGTx and Ankita Desai of Eppendorf Sep 25 2019 2:00 pm UTC 75 mins
    Full Title: Implementation Of An Affordable And Scalable Manufacturing Strategy For Gene Therapy Products
    Presented by Bastiaan Leewis, MSAT Manager of Industrialization at MeiraGTx

    As a start up with multiple clinical programs within an accelerated track we started designing our processes and aimed to build facilities to ensure therapeutic drug products reach patients as quickly as possible. As scientists and as people this tends to be the main goal, and although there are many challenges to commercializing a therapeutic drug product this is only the first step. To be able to continually serve patients, the company must be set up in a way to be sustainable throughout the clinical phase until revenue can be generated via commercial sales. Understanding the patient and company needs are a key cornerstone for having successful products and a successful company transition from clinical to commercial products. Within this presentation I will illustrate and explain the approach chosen by MeiraGTx for some of the platform components.

    Followed by Bioprocess solutions for upstream bioprocess development and scale-up
    Presented by Ankita Desai, Bioprocess Field Application Specialist at Eppendorf

    Upstream bioprocess development is an integral part of gene therapy product development. Cell culture bioprocess development is usually carried out at small working volumes. This helps save time and resources, because several experiments can be conducted in parallel, costs for media are kept low, and relatively little laboratory space is required. When more material is needed for characterization, trial runs, and finally for commercialization, biopharmaceutical companies transition the process to bench scale and then up to pilot or production scale. In this presentation, we will present bioprocess solutions for parallel process development at small scale. Furthermore, we will discuss bioreactor scalability and address several scaling approaches.
  • Cerebral Organoids as a 3D Model for Glioma
    Cerebral Organoids as a 3D Model for Glioma
    Amanda Linkous, Ph.D. Sep 26 2019 4:00 pm UTC 60 mins
    The prognosis of patients with glioblastoma (GBM) remains dismal with a median survival of approximately 15 months. Current preclinical GBM models are limited by the lack of a “normal” human microenvironment and the inability of many tumor cell lines to accurately reproduce GBM biology. To address these limitations, our guest presenter and her team have established a unique model system whereby they can retro-engineer patient-specific GBMs using patient-derived glioma stem cells (GSCs) and human embryonic stem cell (hESC)-derived cerebral organoids. Their cerebral organoid glioma (GLICO) model shows that GSCs home toward the human cerebral organoid, and deeply invade and proliferate within the host tissue forming tumors that closely phenocopy patient GBMs. Furthermore, cerebral organoid tumors form rapidly and are supported by an interconnected network of tumor microtubes that aids in the invasion of normal host tissue. This GLICO model provides a new system for modeling primary human GBM ex vivo and for high throughput drug screening.


    Guest Presenter Bio:
    Dr. Amanda Linkous previously served as the Director of the Starr Foundation Cerebral Organoid Translational Core at Weill Cornell Medicine (New York, NY). She completed her postdoctoral training in the Neuro-Oncology Branch at the National Cancer Institute (Bethesda, MD). Dr. Linkous is currently the Scientific Center Manager for the NCI's Center for Systems Biology of Small Cell Lung Cancer (SCLC) at Vanderbilt University, where she is developing similar 3D model systems to study the biology and refractory nature of SCLC (Nashville, TN)
  • Cost Considerations for the Application of Continuous Processing
    Cost Considerations for the Application of Continuous Processing
    Narasimha Rao Nedunuri, CEO of CLONZ Biotech and José Castillo, PhD, CTo and co-founder of Univercells Oct 2 2019 9:30 am UTC 90 mins
    Cost contribution of continuous manufacturing both in operational and capital expenditure in Monoclonal antibody production.
    Evaluating cost of production per gram conventional fed batch vs continuous process.
    Key considerations for adapting continuous process for the production of Biosimilar MAbs.

    Presented by Narasimha Rao Nedunuri, CEO of CLONZ Biotech

    Narasimha Rao Nedunuri is one of the founding members of CLONZ Biotech, a Biosimilar Monoclonal Antibody company based in Genome Valley, Hyderabad, India.
    He is currently serving the company as the Managing Director & CEO .
    Nedunuri, a Molecular Biologist turned Entrepreneur has 18 years of experience in the field of Life Sciences Research including Cancer Biology, Proteomics, and Molecular diagnostics. He also had business experience in a USA based company, with the responsibility of establishing a business division for its Indian subsidiary.
    At CLONZ , a 7 year old start-up, along with the co-promoters coming from recognized leaders who launched complex Biosimilar MAbs, driving the company to emerge as a significant Global Biosimilar MAb company.
  • Qualification of Raw Materials Used in the Manufacturing of Cellular Therapies
    Qualification of Raw Materials Used in the Manufacturing of Cellular Therapies
    Jim Richardson, Sr Scientific Liaison at USP and Horst Ruppach, Ph.D. Scientific Director at Charles River Oct 7 2019 2:00 pm UTC 90 mins
    Presented by Jim Richardson, Sr Scientific Liaison at United States Pharmacopeia

    Dr. Richardson works in the standards pipeline development group within Global Biologics at USP, leading efforts to develop standards for emerging technologies such as cell and gene therapy. In previous roles at Advanced BioScience Laboratories and Foundation Fighting Blindness, he led translational science activities for the development of vaccines and biologics to prevent and treat infectious and retinal diseases. Trained as a virologist, Jim has also held positions responsible for performing viral clearance testing at Viromed Biosafety and AAV vector development and characterization at Genovo/Targeted Genetics. Dr. Richardson earned his Ph.D. in Biomedical Sciences at the Mount Sinai School of Medicine.

    Followed by Viral Safety Aspects of Raw Materials Used in the Production of Biologics Including Cellular Therapy Products
    Presented by Horst Ruppach, Ph.D. Scientific Director Viral Safety at Charles River's Biologics Testing Solutions

    After a short review of regulations/guidance related to viral safety aspects of raw materials the in principle concept for ensuring viral safety will be outlined. The viral risk profile of a raw material is defined based on the source material, the sourcing process and the subsequent manufacturing and/or purification process. Testing for viruses performed on the start material and/or process intermediates is one way to mitigate the viral risk. Different methods for testing will be presented and the pros and cons discussed. Analyzing the viral clearance capacity of the manufacturing process is another important strategy to reduce the viral risk significantly if applicable. There are, however, experimental challenges sometimes which makes it difficult to demonstrate efficient viral clearance even though the treatment is known to be highly efficient.
  • FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufa...
    FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufa...
    Lily Koo, Consumer Safety Officer at Food and Drug Administration Oct 16 2019 2:00 pm UTC 90 mins
    Full Title: FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufacturing

    The manufacturing processes for cell therapy products can be highly complex, non-conventional, and product-specific. Aseptic techniques are often required throughout manufacture. The challenge to appropriately and effectively validate aseptic processing requires that industry and regulatory bodies rethink how validation strategies are best applied to this novel class of products. This presentation will address FDA perspective on aseptic process simulation for cell therapy products. It will highlight some unique manufacturing/processing features that are shared among cell therapy products and should be considered during aseptic process simulation study design. The presentation will also cover elements of the traditional validation approach and how they could be appropriately applied to cell therapy manufacturing. Case studies will be presented and discussed.

    Presented by Lily Koo, CBER at Food and Drug Administration

    Lily Koo is a Consumer Safety Officer in the Division of Manufacturing and Product Quality (DMPQ) in the Office of Compliance and Biologics Quality (OCBQ), at FDA’s Center for Biologics Evaluation and Research (CBER). Her primary responsibilities include review of facility and equipment information in license applications and supplements for viral vaccines, blood fractionation products, cell and gene therapy products, and in vitro diagnostic kits. Lily also conducts pre-license and pre-approval inspections of biological manufacturing facilities. Prior to joining CBER, she worked two and half years at the Center for Device and Radiological Health and ten years at the National Institutes of Health. Lily received her B.S. in bioengineering from the University of Pennsylvania and her Ph.D. in chemical engineering from Massachusetts Institute of Technology.
  • 爱思唯尔卓越科研在线讲座重播:在《柳叶刀》上发表论文——专为中国研究人员打造的中文在线讲座!
    爱思唯尔卓越科研在线讲座重播:在《柳叶刀》上发表论文——专为中国研究人员打造的中文在线讲座!
    Helena Wang Oct 17 2019 11:00 am UTC 63 mins
    与《柳叶刀》亚洲区执行主编王辉(Helena Wang)女士一起学习在高影响力期刊上发表论文的技巧和策略。王辉女士分享了她在整个研究论文发表周期中与研究人员和论文作者合作的经验,介绍如何撰写能够在优质出版物上发表的论文,以及广泛传播研究成果的机会。本次研讨会内容精彩纷呈,不容错过,能够让您的研究过程和研究影响再上新台阶。This webinar is in Mandarin (Chinese).
  • Upstream Viral Risk Mitigation Strategy for High Titer Biologics Manufacturing
    Upstream Viral Risk Mitigation Strategy for High Titer Biologics Manufacturing
    Aaron Mack, Engineer at Biogen & Dave Kolwyck, Director at Biogen and David Gemmel Senior Process Engineer at Merck Oct 17 2019 2:00 pm UTC 90 mins
    Presented by Aaron Mack, Engineer And Dave Kolwyck, Director Materials Science at Biogen

    Viral contamination from upstream raw material components can wreak havoc on pharmaceutical manufacturing processes, ultimately affecting cell performance and final product quality. To adequately address contamination issues, manufacturing processes typically must be halted for full site decontamination which can take several months and potentially result in a drug shortage [1, 2, 3, 4]. Biogen has taken a risk-based approach to upstream raw material contamination by elimination of animal-sourced raw materials, by identifying higher risk material and using proven viral mitigation methods that minimize detriment to raw material performance. Outsourcing of these raw material viral mitigation methods to raw material suppliers with expertise in the field has allowed for quick transition to raw materials that provide lower risk to the manufacturing process.

    This talk will focus on the risk based approach that Biogen used for determining which raw materials to initially include in its upstream raw material viral risk mitigation portfolio. High Temperature Short Time (HTST) at raw material suppliers is an integral part of this risk mitigation approach. The merits of a risk-based approach to upstream viral safety will be explored, highlighting the HTST pasteurization viral mitigation capability suppliers like Merck have introduced and expanded. Treatment parameters have been detailed in publically available peer reviewed literature and confirmed in specific raw material components prior to implementation in commercial manufacturing processes. Additionally, benefits of decoupling materials with high risk of viral contamination will be reviewed.

    Followed by a presentation presented by David Gemmel Senior Process Engineer at Merck
  • Design of remote luminescent thermometers for bio-imaging
    Design of remote luminescent thermometers for bio-imaging
    Dr. Markus Suta, Utrecht University Oct 24 2019 1:00 pm UTC 60 mins
    Join Reaxys Prize Club member Dr. Markus Suta for fascinating insights into luminescence thermometry. In this webinar, he describes the development and validation of remote lanthanide-based luminescent thermometers with applications in bio-imaging. Discover why a combination of in silico modelling and wet-lab experiments were essential to the success of the project. Dr. Suta also talks about the importance of efficient literature research to his work.
  • Superior Sample Preparation and GC of Fatty Acid Methyl Esters
    Superior Sample Preparation and GC of Fatty Acid Methyl Esters
    Dr. Frank Michel, Analytical & Chromatography Scientific Advisor, Merck KGaA Darmstadt, Germany Oct 30 2019 7:00 am UTC 75 mins
    Fatty acids are important analytes for nutritional value, product taste/texture, shelf-life and place of origin studies. They are not only relevant in food, but also in clinical, biochemical, industrial, agriculture testing.

    In this talk we will give the background of fatty acid analysis and describe some current techniques and new developments for the GC analysis of fatty acids in a variety of applications. A special focus of the webinar is the separation of cis and trans isomers by either a sample prep approach using SPE or by improved GC approaches.
  • Cost & Management of Oncology Combination Regimens
    Cost & Management of Oncology Combination Regimens
    Marcia Palmer, Pharmacy Director, Allen W. Becker, CVS Health, Anthony Chiefari, Highmark Inc. Howard Deutsch, ZS Associates Oct 30 2019 2:00 pm UTC 90 mins
    Overview
    Oncology treatment increasingly involves combinations of novel oral and biologic drugs. While combo approaches aren’t new, there are significant cost implications of combining high priced innovator drugs (versus older, generic chemotherapies).

    Payers are in a difficult spot regarding the cost and management of these regimens. Traditional utilization management tools are still difficult to apply in oncology, given no payer wants to be on the front page of a major newspaper for denying treatment. Pathways have not held up to their promise for containing cost.

    Personalized medicine approaches such as biomarkers serve an important role in targeting therapy to the most appropriate patients, thereby reigning in cost. However, there are limitations in the breadth and utility of these tools. For example, PD-1/PDL-1 drugs have shown conflicting outcomes associated with receptor expression – and these drugs are the backbone for many combo regimen programs in clinical development.

    Environment/perception shifts, new approaches to management, indication-based pricing or other novel pricing approaches, and innovative payment models may hold promise for controlling cost in this new era of combination therapy.

    Focus
    Join ZS Associates for a live expert payer panel discussion on the challenges and potential solutions for managing the cost of combo oncology regimens. Topics will include:

    •Perspectives on oncology drug management and combination regimen pricing today
    •Potential payer-driven and pharma-driven solutions to price and cost management for oncology combo regimens
    •What oncology manufacturers should consider in engaging payers in the future

    The live payer webinar, co-moderated by Nicolle Hamilton, ZS Associates and Dominic Tyer, pharmaphorum, will take place on Wednesday, October 30 2019 from 14:00-15:15 GMT/10:00-11:15 ET.
  • Engineering First Principles: Applications to Pharmaceutical Manufacturing
    Engineering First Principles: Applications to Pharmaceutical Manufacturing
    Bernard McGarvey, PhD Chemical Engineering Nov 5 2019 3:00 pm UTC 90 mins
    Within the pharmaceutical industry, creating a robust Operational Control Strategy (OCS) is a key step to accomplishing the goals of Quality by Design (QbD). Along the way to developing this robust Operational Control Strategy many problems will be encountered that need to be solved. The use of a First Principles based approach provides value because it improves the effectiveness and efficiency of our problem solving, thereby leading to solutions that are more likely to work without unintended consequences and were created in a faster and more cost effective manner. Based on the author’s experience, a clear definition of what First Principles are will be given (and what they are not!). Areas of opportunity where the application of First Principles is likely to be successful will be described. An outline of a high-level process for implementing a First Principles based approach will be presented. Finally an example of the application of First Principles in the pharmaceutical industry will be briefly described.
  • Pharmaceutical Forensics for Safe Manufacturing and Supply
    Pharmaceutical Forensics for Safe Manufacturing and Supply
    Ravi Kalyanaraman and Jeremy Peters of BMS and Robert Heintz of Thermo Fisher Scientific Nov 6 2019 6:00 am UTC 76 mins
    Why Use Raman Microscopy for Pharmaceutical Forensics?
    by Dr. Robert Heintz, Senior Applications Specialist at Thermo Fisher Scientific

    Raman microscopy is uniquely suited for providing essential information for pharmaceutical forensic applications. The use of visible lasers allows for analysis of very small samples with spatial resolutions down to a micron or better. Materials can be analyzed in glass containers and through transparent packaging. Mapping and imaging provides information on the spatial distribution of components as well as particle sizes and shapes. Confocal operation allows for probing inside transparent materials and analyze different layers or inclusions without the need to cut or cross-section the sample. Raman microscopy is non-destructive and preserves the sample for further analysis. Raman spectra can be used not only for the conformation of expected components but also the identification of unknown contaminants or impurities. Spectral features are very sensitive to molecular structure and can be used to distinguish polymorphs and other very chemically similar materials.

    Followed by Pharmaceutical Forensics for Safe Manufacturing and Supply
    by Ravi Kalyanaraman, Director at BMS

    Pharmaceutical Investigations and Technology (PIT) is a group within Global Analytical Technology (GAT) department in the commercial Quality organization within Bristol-Myers Squibb. The PIT group has been a key part in BMS for 30 + years in providing analytical support for commercial manufacturing and in pharmaceutical forensics. This include particulate and foreign matter characterization in pharmaceutical products and screening counterfeit drugs. Several analytical tools and techniques are used by PIT to support the pharmaceutical forensics.This talk will feature all the analytical techniques used by PIT and how the results are used in resolving manufacturing issues and to protect patients from counterfeit drugs.
  • Viral Safety by Design for Cell and Gene Therapy Products
    Viral Safety by Design for Cell and Gene Therapy Products
    Mark Plavsic, Chief Technology Officer at Lysogene & Archie Lovatt, Life Sciences Biosafety Scientific Director at SGS Nov 11 2019 2:00 am UTC 67 mins
    Together with product efficacy, product safety is an essential characteristic of any medicinal product including cell and gene therapy (C&GT) biologics. Adventitious agents (viruses, bacteria, mycoplasma, prions, etc) pose constant risk to these biologics, and, as such they may impact directly product and patient safety. It is therefore of supreme importance to intentionally (by design) employ effective measures across the whole C&GT product manufacturing process to mitigate risk of adventitious agents. This presentation will review various interconnected steps throughout the manufacturing process, from the raw materials to the fill and finish, that would, in concert, help mitigate the risk while providing a high degree of product safety by design.
  • Just in Time Release of CAR-T Cell Therapies
    Just in Time Release of CAR-T Cell Therapies
    Irving Ford, Head of CAR T QC Laboratories at Celgene and Lori Daane, Pharma Microbiology Scientific Director at bioMérieux Nov 11 2019 3:00 pm UTC 90 mins
    Presented by Irving Ford, Head of CAR T QC Laboratories at Celgene

    The views and opinions expressed during the Webinar are those of the presenter.

    Currently CAR T products typically represent the final treatment option for patients suffering from various forms of cancer. It is critical that CAR T products are manufactured and returned to the patient in an expedited manner. As such manufacturers of CAR T products must adopt and utilize Quality Risk Management (QRM) principles during manufacture, testing, and release.
    Risk based contamination control strategies must be employed from apheresis collection through final product release. A risk assessment, encompassing each step of the manufacturing process, should be performed to highlight potential areas of microbial ingress. Where possible, mitigating actions must be implemented eliminate the risk or to reduce the risk to an acceptable risk level.
    Based on a well-defined and documented microbial contamination control strategy, it should be possible for manufacturers to implement a just-in-time microbiological release strategy. This Webinar will highlight microbial contamination control and testing strategies that can be employed throughout each stage of the manufacturing process that will allow for a potential just in time release of CAR T products.

    Followed by a presentation presented by Lori Daane, Pharma Microbiology Scientific Director at bioMérieux
  • Biopharmaceutical Process Model Evolution – Enabling Process Knowledge Continuum
    Biopharmaceutical Process Model Evolution – Enabling Process Knowledge Continuum
    Saly Romero-Torres, PhD, of Biogen and David Lovett & John Mack of Perceptive Engineering Nov 15 2019 3:00 pm UTC 90 mins
    Full Title: Biopharmaceutical Process Model Evolution – Enabling Process Knowledge Continuum from an Advanced Process Control Perspective

    Presented by Saly Romero-Torres, PhD, Senior Manager, Advanced Data Analytics, Biogen

    Biogen is adopting modeling maturity models similar to the ones used by high tech industries such as semiconductors, electronics and AI. The focus of this maturity model is to ensure that a plan for model evolution is conceived, and socialized, among SMEs and regulatory agencies early on during process development. This plan is crucial particularly when implementing data driven models that rely on process experience. A well-planned modeling continuum should allow the pharmaceutical industry to realize the benefits from modeling activities early on, while evolving into more mature prescriptive controllers that operate within Established Conditions (EC) and are potentially implemented through Post-Approval Change Management Protocols (PACMPs).

    Followed a Presentation by David Lovett, Managing Director & John Mack, Engineering Director at Perceptive Engineering
  • Identification of unknown extractables and leachables using mass spectrometry...
    Identification of unknown extractables and leachables using mass spectrometry...
    Petra Booij, Investigator at GlaxoSmithKline & Dr Kyle D’Silva, Pharma & BioPharma Marketing Leader, Thermo Fisher Scientific Nov 21 2019 3:00 pm UTC 90 mins
    Full Title: Identification of unknown extractables and leachables using mass spectrometry: Identification with confidence?

    Extractable and Leachable (E&L) studies on materials used in the manufacturing process and container closer systems of drug products and drug substances are commonly used to assess the risk for patient exposure. Most often LC-MS or GC-MS is used to detect, identify and then quantify extractables and leachables. In general, an analytical evaluation threshold or reporting threshold is set based on a calculated patient exposure. Substances above the set threshold required further investigation if patient exposure exceeds this. Substances can be identified using mass spectral libraries to enable a toxicological risk assessment which considers the risk of patient exposure. However, how confident are we when we identify a substance using spectral libraries? A match with mass spectral libraries, data from orthogonal techniques, fragmentation data and availability of a certified reference standard can increase the level of confirmation. We will discuss an approach for different levels of identification and how to increase the level of confidence of identified extractables and leachables
  • Monitoring Impurities in Biologics
    Monitoring Impurities in Biologics
    Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia  Nov 26 2019 3:00 pm UTC 90 mins
    The complexity of biotherapeutic products and their manufacturing processes can yield a variety of impurities, which must be monitored and controlled to minimize safety concerns and ensure product quality. These impurities can be broadly grouped into two categories: 1) product-related impurities, such as precursors, aggregates and degradation products, and 2) process-related impurities, such as host cell DNA, host cell protein, and particulates.  This presentation will provide an overview of approaches for monitoring impurities, including a discussion of existing USP standards and standards under development to support impurity testing.

    Presented by Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia 

    Dr. McCarthy is a Senior Manager, Science and Standards within USP’s Global Biologics Department. Diane works with stakeholders to identify areas where standards are needed and define and develop new standards. Prior to joining USP, Dr. McCarthy was Senior Scientific Director at Caprion Biosciences, where she focused on the use of mass spectrometry for characterization of biologics and host cell proteins. Her previous roles also included Director of Scientific Affairs at Ezose Sciences, where she focused on identification and quantitation of glycans by mass spectrometry and Global Manager, Biomarker Research Center, at Bio-Rad Laboratories, where she directed translational and biomarker research contracts and collaborations with industry, key consortia, academic, and government groups.
  • Clone Wars: An In Depth Look at Mouse vs Rabbit Antibodies
    Clone Wars: An In Depth Look at Mouse vs Rabbit Antibodies
    Faris Omary and Leah Hartman Dec 11 2019 4:00 pm UTC 75 mins
    Have you ever found yourself wondering which clone of Napsin A to use? What about PAX-8? Or the ongoing dilemma of ordering a mouse monoclonal vs rabbit polyclonal? Then this webinar is for you!
    In this presentation we will explore how antibody's are produced in their corresponding hosts. From there we will identify the main differences between the most popular types of antibodies, including mouse and rabbit monoclonals, and rabbit polyclonals. We will then compare the performance of specific clones that are backed by NordiQC data. We hope this will aid in choosing the best clone for your IHC tests.
  • Qualification of Raw Materials and Cell Substrates for Biomanufacturing
    Qualification of Raw Materials and Cell Substrates for Biomanufacturing
    Maura Kibbey Director, Science & Standards at USP and Martin Wisher, Global Head of Regulatory Affairs at Merck Jan 16 2020 3:00 pm UTC 90 mins
    The quality of starting materials is critical for successful pharmaceutical manufacturing strategies. For biomanufacturing the challenges are further amplified due to the use of a wide variety of raw materials, cell lines, and naturally-derived materials with an increased risk for the introduction of unwanted impurities and adventitious agents. This presentation will provide an overview and updates on USP documentary standards containing best practices for qualifying incoming materials, demonstrating viral clearance, cryopreservation, cell banking, and controlling impurities derived from cell substrates for therapeutic proteins.

    Presented by Maura C. Kibbey, Ph.D., Director, Science & Standards, Global Biologics, U.S. Pharmacopeia

    Dr. Maura Kibbey is a Senior Scientific Fellow for Education and Training in USP’s Global Biologics Department. As USP’s refocused its strategy for biologics standards, Dr. Kibbey has collaborated with scientific experts and trainers to bring many more educational offerings to USP’s stakeholders. Not only to demonstrate the utility of these new standards but to also receive more feedback on future standards for advanced therapies. This role builds on her previous responsibilities directing USP scientists developing compendial standards.  Before joining USP, Dr. Kibbey worked for several biotechnology and diagnostic companies in the Washington DC area in scientific, management, marketing, and business development roles, as well as performing cancer research at the National Institutes of Health. Her scientific expertise includes development and validation of many different assay types for measurement of individual molecules, their activities, or binding interactions. She has published over 40 peer-reviewed articles and has been an invited speaker or workshop organizer for numerous scientific conferences.
  • Utility of Generating  Data: Drug Manufacture’s Perspective: Will USP...
    Utility of Generating Data: Drug Manufacture’s Perspective: Will USP...
    Ken Wong, Deputy Director at Sanofi Pasteur and Desmond G. Hunt, Principal Liaison at United States Pharmacopeia Jan 21 2020 3:00 pm UTC 90 mins
    Full Title:Utility of Generating Data: Drug Manufacture’s Perspective: Will USP permit such format?

    Presented by Ken Wong, Deputy Director at Sanofi Pasteur

    This talk will focus on an overall application of USP starting from risk assessment to qualification of disposable manufacturing systems based on USP data set. All the key principles with examples where these principles need to be satisfied before one can apply the USP data for disposable manufacturing system qualification will be discussed and illustrated. Lastly, different qualification approaches will also be presented to provide broader understanding.

    Followed by a presentation by Desmond G. Hunt, Principal Liaison at United States Pharmacopeia

    Dr. Desmond G. Hunt has been with USP since 2005 and holds the position of Principle Scientific Liaison in the Compendial Science Group-General Chapters. He is the scientific liaison to the Packaging and Distribution and Dosage Forms Expert Committees, where he works to develop and revise USP Standards. He has authored many publications and peer-reviewed articles and is a frequent speaker and instructor on topics related to pharmaceutical packaging, particulate matter in parenteral and ophthalmic dosage forms and good storage and transportation practices. He participates on several industry Working Groups and Technical Committees related to his areas of expertise. Dr. Hunt obtained his M.S. and Ph.D. from the University of Texas at Austin and prior to joining USP, was a Research Fellow at the National Institutes of Health, Bethesda, MD, USA
  • Identification of Approaches to Simulated Leachable Studies: What are They? W...
    Identification of Approaches to Simulated Leachable Studies: What are They? W...
    Jason Creasey, Analytical Chemist at GSK Feb 3 2020 3:00 pm UTC 90 mins
    Full Title: Identification of Approaches to Simulated Leachable Studies: What are They? When to do Them?

    The term “Simulated leachable studies” is open to interpretation. I hope to provide a definition of this term and in doing so suggest when they can and should be used. The general aim of such studies is to provide an accurate qualitative and quantitative description of the substances which might be present as leachables in a pharmaceutical drug product (DP) derived from container closure system (and sometimes its manufacturing process) when the drug product is stored up to and including its shelf-life. Simulated studies provide an alternative to analysis of leachables directly in the drug product. A simulated study aims to avoid some of the downfalls of leachable analysis such as; inaccurate analysis of leachables due to interference from drug product and/or formulation elements, availability of stored DP samples, reaching required limits of detection in the DP and time / resource constraints associated with complex method development using DP.
    Simulated leachable studies must be able to accurately simulate the expected leachables in a DP and should be carefully crafted to achieve this. The system used for extraction must have similar propensity to leach from materials under study a drug product and care must be taken not to use system which either leach too much (potentially masking other substance) or too little.