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Medical Research

  • Introducing Embase French Local Literature Module
    Introducing Embase French Local Literature Module
    Iveta Petrova Recorded: Feb 19 2019 49 mins
    Literature is one of the essential sources to identify high quality adverse drug reaction (ADR) reports. Regulatory authorities require companies to monitor major international publications through databases, as well as local, non-English content sources in each of the countries where the drugs are marketed. In November, 2018, Embase introduced the first non-English content – French Local Language Module, which is designed to screen, review and monitor French literature for pharmacovigilance.

    In this webinar, Embase product manager Iveta Petrova will discuss:
    -The challenges in Local Literature Monitoring process for pharmacovigilance
    -The concepts of Embase French Local Literature Module
    -How to use this module in Embase.com to build effective searches to identify the mention of drugs and ADRs in French journals

    About the speaker:
    Iveta Petrova holds a Ph.D. from Leiden University for research done on Wnt signaling in the nervous system. She joined the Embase team at Elsevier as part of the Content quality department. For 2 years she was responsible for writing and updating the indexing guidelines, as well as monitoring the quality of indexing. One year ago she joined the Product management team of Embase. Currently her tasks include continuous engagement with customers and market research to further improve and develop tools to support them in their daily responsibilities, specifically the enhancement of evidence-based medicine, pharmacovigilance and medical device clinical evaluation and safety.
  • Quality-By-Design in Spray Drying Processes - Transfer Lab to Production
    Quality-By-Design in Spray Drying Processes - Transfer Lab to Production
    Sune Klint Andersen, Janssen Pharmaceutica & João Vicente Senior Scientist - Particle Engineering Team Leader at Hovione Recorded: Feb 19 2019 77 mins
    Spray drying is a continuous and scalable manufacturing process commonly used in the pharmaceutical industry. Due to its scalable and continuous nature it is possible to apply Quality-by-Design (QbD) and Process Analytical Technologies (PAT) early on in the development of a spray drying process.
    Knowledge gained from QbD e.g. Design-of-Experiments (DoE) and PAT increases process understanding and the knowledge can be readily applied when scaling up the process and in production scale application of PAT i.e. especially with respect to the control strategy.
    The Webinar will discuss the application of QbD early in the development and how the obtained knowledge can be used to optimize transfer of the spray drying process to production scale including PAT strategy.
  • Host Cell Protein Characterisation and Mass Spectrometry Strategies
    Host Cell Protein Characterisation and Mass Spectrometry Strategies
    Xuezhi Bi, Group Leader (Proteomics) /Senior Scientist, Bioprocessing Technology Institute, A*STAR  Recorded: Feb 19 2019 37 mins
    Adding Mass Spectrometry as part of the host cell protein workflow
    Analytical Strategies in HCP identification and purification process
    Developing Quantitative MS/MS method to determine HCP Levels
  • Just What the Dr Ordered for UK Life Sciences? The 2nd Life Sciences Sector Deal
    Just What the Dr Ordered for UK Life Sciences? The 2nd Life Sciences Sector Deal
    Erik Nordkamp, GM UK, Pfizer, Dr Keri Torney, Deputy Director Life Sciences, NHS England, Angela McFarlane, IQVIA Recorded: Feb 7 2019 73 mins
    Brexit uncertainty isn’t going away any time soon – but it’s important to remember that the UK government has already set out two plans for the future shape of the country’s healthcare industry: the second Life Sciences Sector Deal and the long-term plan for the NHS.

    With these two plans in place there are plenty of opportunities for the industry and the government to work together to keep the UK at the top of the international life sciences sector – and perhaps reach even greater heights.

    This pharmaphorum webinar, held in partnership with IQVIA, will analyse the current and future landscape for UK life sciences as well as what steps have been taken so far to boost the sector.

    Panellists from across the industry will look at the challenges presented by the current situation with Brexit and how the 10-Year Plan and the Sector Deal 2 (or 2018) play into this. They will discuss the positive steps taken by the government to prepare NHS innovation for a radically different future and make sure the UK remains an attractive location for ongoing inward investment from global pharma.

    Topics to be covered include:

    •Highlights of the 10-Year Plan and the second Sector Deal
    •Progress with the current Life Sciences Industrial Strategy, the Sector Deal and plans for 2019
    •The NHS innovation uptake agenda
    •Maintaining UK attractiveness for inward global pharma and biotech investment
  • 2019 Life Science Predictions: Decoding 5 Incredible Growth Opportunities
    2019 Life Science Predictions: Decoding 5 Incredible Growth Opportunities
    Nitin Naik, Unmesh Lal, Khushbu Jain, Fred Mao, Barbara Gilmore, Frost & Sullivan Recorded: Feb 6 2019 74 mins
    The Life Science industry is in a state of flux. While recent years have seen the advent of multiple novel technologies—such as IVF, CRISPR-Cas9, virtual clinical trials, and liquid biopsy—the industry today stands at a crossroads with challenges in scaling up and commercializing such technologies. The industry has now come to terms with new, path-breaking life science technologies that are helping make precision healthcare a reality. Chinese investments into the US biopharma industry jumped to $4.5 billion in 2018. An exclusive fireside chat with our US and China analysts will uncover trends in cross-border investments and growth opportunities in these two markets.

    Key Takeaways:

    • Establish the leading factors that will influence the size and direction of the global life sciences market in 2019.
    • Build clarity on technology developments in the global life sciences market in 2018 that will have an impact during 2019.
    • Identify the business models used to commercialize and distribute novel life science solutions.
    • Discover the key growth opportunities and strategic imperatives for companies in 2019.
  • Using In-Vitro Dissolution to Support Post Approval Changes Global Regulatory Ex
    Using In-Vitro Dissolution to Support Post Approval Changes Global Regulatory Ex
    Dr Xin Bu, Principal Scientist, Bristol-Myers Squibb Recorded: Feb 5 2019 43 mins
    Dissolution is one of the critical quality attributes for solid oral dosage forms, typically tablets and capsules. In addition as a quality control (QC) test to release commercial products, dissolution is often used as a comparative test to 1) apply biowaiver for lower strength(s) when multiple strengths of one product with the same or similar formulation are marketed, or 2) support post approval changes. In these cases, in-vitro dissolution test is used in place of in-vivo bioequivalence study to establish equivalency between products of different strengths or pre- and post-change. Guidances provided by major regulatory agencies, the United States Food & Drug Administration (US FDA) and European Medicines Evaluation Agency (EU EMEA) are often followed by many countries around the world. However some countries/ regions, such as Australia, Japan, China, Taiwan and Korea have their own country specific guidances. The dissolution requirements by the FDA and EMEA are generally similar, and depend on the type and level of changes as outlined in the relevant guidances. The requirements from other mentioned countries are often significantly different from that of US and EU, and different from each other. For products marketed globally, it’s prudent to understand the differences amongst the different country requirements when applying post approval changes using dissolution to demonstrate equivalency. Several sets of comparative dissolution studies may have to be conducted in order to satisfy all regulatory agencies. This presentation compares differences in dissolution testing requirements among the listed countries and provide examples to illustrate how for conduct studies to comply with the relevant guidance(s).
  • Cancer, genomics and personalised medicine: Modelling the future of oncology
    Cancer, genomics and personalised medicine: Modelling the future of oncology
    Danyi Wen, Shanghai LIDE Biotech, Stefan Jellbauer, Mitra Biotech, Lakshmi Santhosh Maithel, Repositi Recorded: Jan 29 2019 61 mins
    The prevalence of cancer is currently predicted to be higher than ever. Current statistics show 1 in 2 people in the UK and 1 in 2 men/1 in 3 women in the US will experience it at some stage in their lives. And yet the picture for patients is an improving one.

    The move towards immunotherapies heralds much promise and this is potentially just the beginning. As cancer is understood increasingly not by type, or even tumour type but specific mutation the era of personalised oncological therapies is visible.
    To delve further into this pharmaphorum is pleased to present an exclusive online discussion.

    Bringing together experts at the cutting edge of this field it aims to interrogate where we are in terms of this shift towards personalised oncology, what this means in terms of the development pathway and looks at the approaches which could (and will) fully evolve the way that cancer treatments are developed in terms of efficacy, approach and outcome.

    this free to attend event will cover a number of topics critical to the future of oncology including:
    •The changing face of cancer: how do we define it now?
    •Personalised medicine in practice – where are we now in cancer?
    •What are the implications from these changes for clinical trials?
    •How the shift towards cancer as a phenotype/genotype is being applied in clinical trials and how they are run
    •What are co-clinical trials and why could they hold the key to answering unmet need in cancer treatment and beyond into broader drug development?
    •Modelling for the future of cancer – can this be done for personalised therapies?
  • Cell Culture Masterclass: A 10-Point Plan to Prevent Contamination
    Cell Culture Masterclass: A 10-Point Plan to Prevent Contamination
    Franziska Wienholz, Scientific Support Specialist, Corning Life Sciences Recorded: Jan 28 2019 44 mins
    Cell Culture Masterclass: A 10-Point Plan to Prevent Contamination

    All cell culture laboratories have experienced it: cell culture contamination and its inevitable loss of material. Contaminants may be biological or chemical, visible or invisible, destructive or seemingly benign, but in all cases, they adversely affect both the use of your cell cultures and the quality of your research.

    Identification and, even better, prevention of contamination are crucial for ensuring high-quality research. This expert webinar will present an overview on how to prevent, recognize and tackle contamination by introducing good lab practices and targeted interventions.

    If you work with cell culture daily or are interested in setting up prevention strategies to minimize contamination, then join SelectScience and Franziska Wienholz, scientific support specialist of Corning Life Sciences, for this educational masterclass. Franziska will share a 10-point plan to prevent contamination and provide a comprehensive refresher on all aspects of cell culture.

    Key learning objectives:

    Understand the basic rules of cell culture
    Know how to properly manage cell lines to prevent cross-contamination
    Be able to implement a 10-point plan to contamination prevention in your laboratory

    Who should attend:
    Scientists working with cell culture on a daily basis
    Cell culture managers who are interested in setting up programs to prevent contamination and determine authentication of cells
    Researchers that struggle with contamination issues
  • Advances in three-dimensional Cell Culture
    Advances in three-dimensional Cell Culture
    Dr. Richard E. Eglen, Vice President and General Manager, Corning Life Sciences. Recorded: Jan 28 2019 62 mins
    Advances in three-dimensional Cell Culture in Drug Research, Discovery and Biologic Manufacture.

    Cellular research is optimal when using physiologically relevant cell phenotypes and genotypes of human origin. This assertion has accelerated the adoption of primary cells, stem cells, and, increasingly, patient-specific cells in drug discovery. Over the past five years, technological improvements in 3D cell culture technology, to better mimic in vivo physiology, have also advanced. This is true not only in the areas of cancer and neurological research, but also in the assessment of clinical candidates for metabolic and toxicological liabilities. Furthermore, 3D cell culture is facilitating novel approaches to both the scale-up and manufacture of biologics, including those used in immuno- and stem cell-based therapies.

    Are you a scientist interested in 3D cell culture? Join this expert webinar, in which Dr. Richard Eglen will discuss the importance of 3D cell culture in drug discovery and manufacture and how technological improvements are causing significant advancements in this field.

    Learn about:

    - The existing and future impacts of 3D cell culture technology on fundamental research
    - The impacts of 3D cell culture on drug discovery and manufacture, particularly in the context of using phenotypically relevant cells?
    - The potential for spheroids, organoids, scaffolds, and hydrogels in cellular research and compound identification, screening, and development?
  • Raw Material Lot Variability Challenges During Manufacturing of Biosimilars mab
    Raw Material Lot Variability Challenges During Manufacturing of Biosimilars mab
    Sekhar Reddy, DSP Lead for Biosimilars at Biocon MSAT Recorded: Jan 25 2019 34 mins
    Downstream processing of Biosimilar Monoclonal Antibody utilises variety of raw materials that a critical for achieving the desired product quality. In this webinar, we would like to discuss the data from three cases of lot to lot variability namely Depth filtration, Chromatographic resin and buffer component used in downstream chromatography unit operations. Changes in lots of depth filter resulted in significant clogging and differences in Host cell impurity clearance. Similarly, changes in resin lots resulted in increased back pressure during processing and variability in buffer raw material lots resulted in undesirable colouring of resin upon contact. In each case, we will present the root cause investigation, impact on product quality profile and associated CAPAs to control the effects of variability to ensure manufacturing continuity.
  • Metrics to meaning: demonstrating the value of medical communications
    Metrics to meaning: demonstrating the value of medical communications
    Scott McGregor, Allergan, Lynda Chang, Complete HealthVizion, David Pearce, Complete HealthVizion, Dominic Tyer, pharmaphorum Recorded: Jan 23 2019 62 mins
    Medical affairs and publications teams are under increasing pressure to demonstrate effectively the success of the medical communications activities they undertake.

    Naturally, there are a huge number of metrics that could be used to measure and demonstrate medical communications value. The challenge is to identify, and track, those metrics that really matter, and ensure this information is interpreted effectively.

    This pharmaphorum webinar, which will be held in partnership with Complete HealthVizion, will look at how to measure medical communications activities, how to continue with what is successful and how to change what isn’t working.

    This means identifying what can be measured, both in terms of reach and engagement as well as behavioural impact, deciding what ‘great’ looks like and how best to define success.

    The expert panel will also look at how behavioural science can provide a framework to develop smarter communications and, ultimately, drive better patient outcomes.

    This Metrics to Meaning webinar will take place on Wednesday, 23rd January, at 15:00 pm GMT (10:00 EST) and will teach you how to measure the effectiveness of different types of medical communications programmes.

    Interacting with the panel will also allow you to learn about a range of practical approaches to implementing metrics, including:

    • Innovative ways to measure medical communications value and success
    • How to help medical affairs and publications teams demonstrate greater value
    • How to optimise tactical outputs year on year
    • The importance of demonstrating and measuring behavioural change

    In doing so they will also discuss the role of behaviour and the implications of this for measuring success.
  • Extractables from Single-Use Bioreactors and Impact on Cell Culture Performance
    Extractables from Single-Use Bioreactors and Impact on Cell Culture Performance
    Yasser Nashed-Samuel, Principal Scientist at Amgen Donald Young, Sr. Product Manager at Thermo Fisher Scientific Recorded: Jan 22 2019 64 mins
    Attribute Sciences, Process Development, Amgen Biopharmaceuticals are drugs manufactured bygrowing genetically engineered cells in bioreactors to produce a therapeutic protein. Plastic single-use bioreactors are of interest to biopharmaceutical drug manufacturers due to their significant environmental and cost benefits and flexibility over stainless steel bioreactors. Effect of plastics on the biomanufacturing process is not yet completely understood. A case study on extractables from single-use bioreactors and impact on cell culture performance will be presented.
  • Researcher Academy: An introduction to e-learning resources for researchers
    Researcher Academy: An introduction to e-learning resources for researchers
    Priyanka Kalra Recorded: Jan 22 2019 33 mins
    Researcher Academy (https://researcheracademy.elsevier.com/) provides free access to countless e-learning resources designed to support researchers on every step of their research journey. Browse our extensive module catalogue to uncover a world of knowledge, and earn certificates and rewards as you progress.
  • How Researchers & Publishers Can Collaborate In The Move Towards Open Science
    How Researchers & Publishers Can Collaborate In The Move Towards Open Science
    Moderated by Stephane Berghmans, Director Academic Relations, Elsevier Recorded: Jan 21 2019 89 mins
    A debate on challenges and opportunities in open access & open data
  • Single Use Manufacturing within the Bristol-Myers Squibb Manufacturing Network
    Single Use Manufacturing within the Bristol-Myers Squibb Manufacturing Network
    Lance Marquardt, Bristol-Myers Squibb & Sara Bell, Merck Recorded: Jan 17 2019 66 mins
    By Lance Marquardt, Associate Director – Upstream Processing for Hopewell Clinical Manufacturing at Bristol-Myers Squibb and Sara Bell, Senior Marketing Manager for Mercks’s single-use product portfolio.
    An overview of the current use of single use manufacturing within the Bristol-Myers Squibb manufacturing networks and planned future state. The challenges in implementing single use manufacturing for commercial production will be discussed. Comparisons will be made to the implementation of past improvements and the plans for future improvements, such as continuous processing.
  • Overcoming Downstream Bottlenecks In The Upscaling Process
    Overcoming Downstream Bottlenecks In The Upscaling Process
    Dr. Dakshesh Mehta, Associate Vice President and Head of Bioprocess Group at Biotech & Genomics division Recorded: Jan 17 2019 35 mins
    In recent years, due to major advances in upstream process, therapeutic proteins can be produced at higher concentrations than ever before. For, these high-titer, high-cell density production, chromatography operations may be as perceived bottlenecks. Column size limitations, low dynamic capacity and buffer volume requirements are generally considered as contributing factors, apart from high resin costs.

    The talk will cover how flexible manufacturing systems could help establish efficient downstream processes to overcome capacity bottleneck. Also how downstream footprint can be reduced whilst speeding up purification process. Is there anyway, one could eliminate chromatography operations with other technologies that may require less space and buffers and also may be more cost effective?
  • Challenges Faced by the End Users During the Qualification of Single Use System
    Challenges Faced by the End Users During the Qualification of Single Use System
    Ben Jeyaretnam, E&L Analytics Lead of Sanofi at Swiftwater and Dr Andreas Nixdorf, Team Manager at SGS Group Recorded: Jan 14 2019 129 mins
    Pharmaceutical industry has been increasingly using single use systems (SUS) for bioprocessing and storage of intermediate and final bulk material in addition to primary packaging. Before a SUS could be used in the manufacturing process, it needs to be qualified for use by a pre-determined process. This presentation will discuss a variety of challenges, both internal and external to the industry that the end use faces during the qualification process. Complexity of SUS, varying quality of vendor data, component change management, changing regulatory expectations, analytical data generation, logistical challenges during E&L study execution, analytical challenges, and the potential impact of unexpected E&L study results will be presented.
  • Reducing Microbiological Risk & Using Quality Tools in the Pharma Industry
    Reducing Microbiological Risk & Using Quality Tools in the Pharma Industry
    Don Singer, GlaxoSmithKline R&D and Jessica Rayser, Product Manager at Charles River Recorded: Jan 9 2019 55 mins
    The pharmaceutical industry paradigm change is occurring and industry has taken an important leap towards formality of quality improvement using quality tools. Recent industry and regulatory support of ‘risk-based’ concepts and principles are leading to a ‘desired state’ of industry development and production of pharmaceuticals that have a higher level of consistency in meeting purity, safety and efficacy.
    Microbiologists’ role as active partners in the pharmaceutical environment is to help transform industry to a routine Quality by Design paradigm. With the help of quality tools and using the concepts and principles of Quality by Design, a better understanding of how and where to implement microbiological control of processes can be developed, and microbiological purity can be built into products for all patient populations.
  • The Modern Management of Brain Metastases
    The Modern Management of Brain Metastases
    Arjun Sahgal MD, FRCPC, Deputy Chief of Radiation Oncology at Sunnybrook Health Sciences Odette Cancer Center Recorded: Jan 8 2019 59 mins
    During the webinar, Dr Arjun Sahgal will share his perspective on the latest trends for treating brain metastases. Dr Sahgal will examine the most recent published clinical data comparing the benefits of SRS with previous treatment techniques, and the use of the most recent technologies available. The session will explore traditional treatments with WBRT and compare some of the latest SRS techniques used to treat specific targets and their clinical outcomes. Discussion is focused on precision radiation medicine, improving outcomes and quality of life for patients.
  • Introduction to writing research articles
    Introduction to writing research articles
    Dr Trevor Lane Recorded: Dec 18 2018 61 mins
    Join Dr Trevor Lane as he hosts a webinar covering an introduction to writing research articles. In this webinar, you will learn how to write original research articles clearly and concisely and use an appropriate writing style for journals. You will also gain valuable insight into making strategic publication decisions that will help increase your chances of publication success.

    During this webinar you will hear how to:

    1. Make strategic decisions on how and where to publish your work
    2. Identify the features of effective research articles
    3. Devise some strategies to improve your research writing
  • Authoring in The Lancet — Learn from the Editors!
    Authoring in The Lancet — Learn from the Editors!
    John McConnell, Editor-in-Chief of The Lancet Infectious Diseases Recorded: Dec 18 2018 77 mins
    Join John McConnell, Editor-in-Chief of The Lancet Infectious Diseases to learn about techniques and strategies for authoring in high-impact journals. Mr. McConnell will present his experience working with researchers and authors throughout the research publishing cycle. You will learn how to develop papers for premium publications, and how to broadly disseminate findings. Do not miss this engaging webinar, join and ask any questions that you feel will benefit your research!
  • 6-AM and BUP:  New Useful Assays in the Opiate Crisis
    6-AM and BUP: New Useful Assays in the Opiate Crisis
    Dr. Mary Mayo Recorded: Dec 12 2018 44 mins
    The opiate crisis has reached epidemic proportions, evidenced by more than 17,000 deaths a year and $504 billion in economic costs in the U.S. alone¹. Healthcare providers and laboratories need highly specific tests that accurately detect drugs of abuse in patient-care, employment, athletic and prescription drug monitoring settings.

    In this webinar, Dr. Mary Mayo discusses two highly sensitive assays—the Syva® EMIT® II Plus 6-Acetylmorphine (6-AM) and Buprenorphine (BUP)—that expand available options for drugs-of-abuse testing.

    After attending this webinar, you will be able to describe the:
    • Differences in opioid drugs
    • Magnitude of the opioid epidemic
    • Reasons to use specific drug tests related to opioids
    • Performance characteristics of the Syva EMIT II Plus 6-AM and BUP assays

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

    Presenter: Mary Mayo, Ph.D.

    Dr. Mary Mayo is a medical affairs manager with Beckman Coulter Diagnostics, with more than 25 years’ experience in the clinical laboratory. This includes twelve years as a laboratory director, nine years as director of clinical chemistry at a tertiary-care academic hospital and three years as the laboratory director of a commercial laboratory.

    References:

    ¹ CDC. “Opioid Overdoses Treated in Emergency Departments.” https://www.cdc.gov/vitalsigns/opioid-overdoses/. Accessed 6 Mar 2018.

    *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. Most programs also provide State of Florida credits (with valid license number). 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.
  • The devil’s in the e-detail: what HCPs really want from you
    The devil’s in the e-detail: what HCPs really want from you
    Heiko Schmidt, Integrated Multichannel Marketing and Sales, Bayer, Sari Ruth Carter, Head of Marketing, Anthill Agency Recorded: Dec 6 2018 68 mins
    Overview:
    Communication; we all do it, it is a critical part of effective business practice and in this pharma is no exception.

    It is no secret that for pharma companies, face time with healthcare professionals (HCPs) has reduced drastically over the last 10 years while the cost of in person engagements has increased significantly.

    Like any customer their expectations for the content they receive have changed, with a focus on useful, succinct and easy to consume materials rather than the sales materials of old.

    So what is it that HCPs want and through this lens, what is it that pharma should be doing?

    The evidence points towards creating meaningful two-way conversations through multiple channels, connecting otherwise siloed touchpoints with and for HCPs in the process.

    For the past 40 years detailing has been the backbone of pharma/HCP communication – but what about e-Detailing? Is it just detailing on an ipad or is it supposed to be something more? How does this fit and what is possible, and more importantly desirable?

    To analyse the current situation and present practical insights, pharmaphorum presents a new free to attend digital debate. Working with our partner Anthill agency we have put together a panel of leading experts from Bayer and Anthill.

    This debate will cover:

    •What is the current landscape for optimal HCP communication?
    •What is the future in terms of HCP channel preference?
    •New technologies in pharma marketing that help you to better engage with HCPs and extend HCP reach – AI, chatbots, self-detailing
    •How to reach more HCPs, when, where and how they want
    •How to overcome low content usage by HCPs
    •The most common challenges for traditional eDetailing effectiveness
    •How to achieve better communication without having to reinvent the wheel
    •How to activate your existing content and reach all customers willing to engage with your brand, regardless of their preference.
  • Next Generation IHC
    Next Generation IHC
    Jeff Gordon Recorded: Dec 5 2018 57 mins
    Immunohistochemistry has now been a staple in diagnostic pathology for decades. This is partially due to pathologist utilization of antibodies in the realm of specialty panels. As the science evolves, the panels evolve, creating demand for the next generation of antibodies to improve diagnostic capabilities. This talk will give an overview of some of these novel diagnostic markers and how they fit into the specialty panels with the traditional antibodies to provide the best diagnostic capabilities to the pathologist, therefore giving the patient the best care available.
  • Research Metrics and Your Career
    Research Metrics and Your Career
    Dr. Charles Martinez, Client Consultant Research Management, SciVal Fairy Recorded: Dec 4 2018 39 mins
    Learn about Research Metrics and how to use them responsibly and effectively throughout your academic career. In this session you will learn about ORCID, the H-index and journal metrics including CiteScore and Impact Factor. Our speaker discusses how research metrics can help you chose a publication for your research and how you can use them to help promote your own research.
  • How to drive digital agility & efficiency in the Pharma & Life Sciences industry
    How to drive digital agility & efficiency in the Pharma & Life Sciences industry
    Sean Donnelly (Econsultancy), Toby Donnison (Pharma Lead - Adobe), and Rupert Wills (Solutions Consultant - Adobe) Feb 21 2019 2:00 pm UTC 54 mins
    The 2018 Digital Trends report released by Adobe & Econsultancy found that only 5% of healthcare and pharma organizations reported being digital-first. Yet in today’s digital world, there has never been a better time for the Pharma industry to innovate and improve health outcomes whilst driving business performance. Technology has sparked a revolution across all functions, from research and development to sales and operations. However, meeting these demands is not without its challenges. The unique nature of the pharma and life sciences industry means that it faces issues that other businesses do not have to grapple with. There are complex supplier networks, growing regulatory requirements and increasing pressure to reduce costs – so what can digital leaders do to effect change quickly?

    Join Econsultancy & Adobe in this webinar to learn:
    • The reality of the digital first challenge and the trends causing complexity.
    • How technology is shaping the future and the opportunities for digital agility & efficiency.
    • How Merck transformed time consuming business processes though digital workflows – accelerating business, and improving the employee & customer experience.
    • How electronic signatures can digitally transform your documents and workflows, accelerating an organisations digital transformation journey.
    • How to ensure you stay compliant with regulations including a live demonstration the BioPharma module (covering Title 21 CFR Part 11)
  • Effect of Cell Culture Process Change from Fed-batch to Continuous on...
    Effect of Cell Culture Process Change from Fed-batch to Continuous on...
    Ru Zang, Associate Director at Mersana Therapeutics and John Bonham Carter, Director of Upstream Sales at Repligen Feb 25 2019 4:00 pm UTC 75 mins
    EFFECT OF CELL CULTURE PROCESS CHANGE FROM FED-BATCH TO CONTINUOUS ON PRODUCTIVITY AND PRODUCT QUALITY

    Integrated continuous bioprocessing has attracted a growing interest due to its potential to improve agility and flexibility in the manufacture of therapeutic proteins. To convert an existing fed-batch cell culture process to continuous, or perfusion, the major technical hurdles include maintaining steady state cell culture performance and generating product with comparable product quality attributes. In this presentation, we evaluated three molecules including a fusion protein, an aglycosylated monoclonal antibody (mAb), and a glycosylated mAb. Steady state culture at high cell density was achieved for all three molecules, which allows the delivery of products with consistent product quality and adequate productivity. However, as compared to fed-batch processes, product quality and cell specific productivity differences were observed in perfusion cultures. Further studies indicated that it was feasible to modulate product quality in perfusion process by adding process levers in culture medium. It was also feasible to increase cell specific productivity through medium and process optimization. This presentation provides an insight into the product quality and productivity differences between traditional fed-batch and perfusion cell culture processes and potential approaches to addressing these differences.
  • Continuous Manufacturing: Business Case Drivers and Deployment Strategies
    Continuous Manufacturing: Business Case Drivers and Deployment Strategies
    Lawrence De Belder, Senior Principal Engineer at Johnson and Johnson and Richard Steiner, Business Development Manager at GEA Feb 26 2019 3:00 pm UTC 75 mins
    Continuous manufacturing for Oral Solid Dose drug products has the potential to generate benefits in many different areas of the product life cycle. It will help to improve control and understanding, increase development and transfer speed, assure shorter cycle times, and reduce development, transfer and operational cost.

    If we look at the products which have been approved for commercial production, we see differences in technology, approach, and business case drivers. The main interest is coming from larger pharmaceutical companies, but also generic companies and CMO’s start to invest or have intentions to do so.

    Before implementing a continuous manufacturing process, a number of strategic choices have to be made: start off immediately with new products or learn by converting a legacy batch product into a continuous process without the critical deadline of a launch on your path. A clear development and deployment strategy will help to guide for important choices early on.

    This webinar will give an overview of the different elements that can drive the business case of a continuous manufacturing project, and which strategies could be used to deploy this wonderful technology throughout an organization.
  • Techniques and strategies for submission to The Lancet
    Techniques and strategies for submission to The Lancet
    Dr Diana Stanley, Deputy Editor of The Lancet Respiratory Medicine Feb 26 2019 10:30 pm UTC 75 mins
    Join Dr Diana Stanley, Deputy Editor of The Lancet Respiratory Medicine, to learn about:
    • The Lancet family of journals’ peer review process
    • What Lancet editors are looking for in a submission
    • Strategies for preparing your manuscript for submission to a premium publication
  • Sharpshooters Guide to Troubleshooting IHC
    Sharpshooters Guide to Troubleshooting IHC
    Ourhay Shamoon Feb 27 2019 4:00 pm UTC 75 mins
    Come one, come all to the troubleshooting gallery as we learn sure-fire techniques to troubleshoot IHC stains. Inappropriate stains impact patient care, slow your lab down, and waste reagents, all of which cost your lab money, time, and peace of mind. This workshop will cover common histology and immunohistochemistry protocols, paying close attention to how each step influences stain quality. We’ll take aim at the root cause for most stain issues and set our sights on the red flags to look for when troubleshooting. We’ve got you covered from specimen collection to cover slipping. Too Light, Too Dark, Background, No Stain and the rest of the outlaws won’t stand a chance. You’ll mosey out of this workshop with a thorough understanding of how histology and immunohistochemistry work to produce a quality stain and the tools you will need to efficiently troubleshoot the most common stain issues. Giddy up and count yourself among the ranks of ‘Sharp Troubleshooter’ for your lab.
  • Real Time Online Chromatography Monitoring of Product Quality Attributes for Bio
    Real Time Online Chromatography Monitoring of Product Quality Attributes for Bio
    Dr. Gang Xue, Scientific Director at Amgen Inc Feb 28 2019 3:00 pm UTC 75 mins
    REAL TIME ONLINE CHROMATOGRAPHY MONITORING OF PRODUCT QUALITY ATTRIBUTES FOR BIOLOGICS CONTINUOUS MANUFACTURING PROCESS

    The ever diversifying therapeutic modalities drive for modular and flexible bio-manufacturing, which transformed biologics process from traditional Fed-batch to Single Use BioReactor (SUB), then to Continuous Manufacturing (CM). Process Analytics evolve as critical enabling element of the CM process. It allows to move the release testing from the end of process to real time in the process, which not only eliminates weeks of material disposition delay, but also provides the process scientists product quality insight during the run to make process decisions. However, due to the structural complexity of the bio-molecules, spectroscopic sensors or probes nowadays lack the sensitivity and specificity to illustrate the product quality attributes (PQA) such as protein post translational modifications (PTM). We report here for the first time, we leverage a multi-functional automation system to directly take samples from the different stage of bio-process, purify, denature, derivatize and digest the samples before injecting onto the UHPLC and UHPLC/MS systems, one for online intact protein analysis, the other for Multiple Attribute Method (MAM) analysis for critical PTM PQAs. Benefiting from the high resolution chromatography and mass spectrometry, automated real time bio-molecule product quality monitoring is achieved for both SUB and CM process.

    Dr. Gang Xue is a Scientific Director at Amgen Inc. located in Cambridge, MA. With B.S. degree in Chemistry and B.E. in Computer Science from Tsinghua University and Ph.D in Analytical Chemistry from the Iowa State University, Gang is currently leading the Process Analytics group within Amgen Process Development organization. One of his group’s focuses is the cross modality PAT strategy for the biologics and synthetic continous manufacturing with the goal of process control and real time release testing
  • Risk Based Approaches To Use Of Closed Systems In Renovations Of Existing Biopha
    Risk Based Approaches To Use Of Closed Systems In Renovations Of Existing Biopha
    Lars Hovmand-Lyster of Novo Nordisk GPO and Ernest Jenness of MilliporeSigma Mar 5 2019 3:00 pm UTC 90 mins
    Risk Based Approaches To Use Of Closed Systems In Renovations Of Existing Biopharma API Facilities

    Companies often experience regulatory challenges during inspection of aging facilities, requiring them to initiate projects to optimize product protection and updating to current standards for classified areas for biopharma manufacturing. For a long time the company response have been to improve the existing classified areas or maybe even upgrading to a higher grade of classification. However, it may be more appropriate, and improve product protection, to instead implement the use of closed system processes and downgrade room classification during these facility renovation projects. If closed systems are fully utilised, then a CNC space can be used. As well as reducing complexity of operations, this will reduce capital and operating costs.
    This presentation elaborates the work of BPOG members to harmonize the use of closed systems and define risk based tools and approaches to evaluate appropriate room classification across the Biopharmaceutical industry.
  • Future of Clinical Laboratories—Winning Strategies & Growth Opportunities
    Future of Clinical Laboratories—Winning Strategies & Growth Opportunities
    Divyaa Ravishankar, Industry Principal,Frost & Sullivan, Kyle Fetter, Executive Vice President, XIFIN Mar 5 2019 6:00 pm UTC 60 mins
    What are the winning strategies for a laboratory to be successful? This webinar will focus on the state of the clinical laboratories market in the US, Canada, and Europe. Given the reimbursement cuts, it is essential to understand how this can impact the revenue-generating abilities of clinical laboratories and what strategies they can take now to keep the business profitable.

    Frost & Sullivan invites you to join Divyaa Ravishankar, Industry Principal, Frost & Sullivan and Kyle Fetter, Executive Vice President & General Manager of Diagnostic Services, XIFIN, for the webinar: Future of Clinical Laboratories—Winning Strategies & Emerging Growth Opportunities. The event will provide an overview of the current state of clinical laboratories and recommendations for future success followed by an interactive, live question-and-answer session.

    Key Takeaways:

    • Understand what is driving business for clinical laboratories and what will change in the future
    • Learn how are clinical laboratories adjusting to the declining reimbursement situation
    • Gain insight on ways a data-driven approach can help laboratories increase efficiency
    • Better understand how blockchain applies in the world of clinical laboratory services testing
  • Implementing Digital Signatures For Regulatory Compliance in Life Sciences
    Implementing Digital Signatures For Regulatory Compliance in Life Sciences
    John Jolliffe (Strategic Engagement, Adobe Document Cloud) & Viky Manaila (CEO, Trans Sped) Mar 7 2019 2:00 pm UTC 60 mins
    Pharmaceutical and Life Sciences companies are subject to unique legal and regulatory requirements that fundamentally impact the way they create and manage content and data. What role can digital signatures play in helping companies manage risk and comply with regulations for the management of clinical trials, securing patient informed consent, and the control of good manufacturing practices?

    Join our live webinar to learn how:
    • Life Sciences companies can achieve digital transformation in this highly regulated sector
    • To comply with ICH E6(R2) guidelines on data integrity to avoid rejection of clinical trial data.
    • To secure legally valid Informed Consent and comply with the new EU Regulations on clinical trials data.
    • To work alongside signature solutions in non-regulated areas of life sciences companies.
    • To achieve compliance with SAFE-BioPharma standards.
  • Discoverable Research Workflows
    Discoverable Research Workflows
    Trish Wilgar, SSRN Mar 7 2019 3:00 pm UTC 45 mins
    Introducing the Mendeley Data datasets API on SSRN! Learn more about early stage research and the integration of Mendeley Data datasets on SSRN encourages authors to upload the research data associated with their papers, allowing for greater transparency and reproducibility. SSRN authors get the credit for their research outputs, attract more citations, compliance with funder mandates data sharing, and more. SSRN readers easily access the data, can evaluate and follow the data connections, and use the data to create individual research.
  • Achieving Seamless Scale-Up and Technology Transfer – A Case Study in Single-Use
    Achieving Seamless Scale-Up and Technology Transfer – A Case Study in Single-Use
    Ying Wang, Ph.D., Senior Scientist I, Manufacturing Sciences at AbbVie Bioresearch Center Mar 11 2019 3:00 pm UTC 75 mins
    Title: Achieving Seamless Scale-Up and Technology Transfer – A Case Study in Single-Use Bioreactors

    A systematic scale-up strategy is critical in enabling a rapid and robust technical transfer. For a program involving a CHO cell culture process, a combination of mass-transfer (kLa) studies, computational simulation and scale-down model experiments were used within this newly developed work-flow. Utilizing this approach, scale-up was successfully accelerated (
  • Managing Biologics Process Analytical Technology in Pfizer
    Managing Biologics Process Analytical Technology in Pfizer
    Keith Davis, Principle Scientist at Pfizer Mar 12 2019 3:00 pm UTC 75 mins
    Coordinating PAT between development and manufacturing organizations is always challenging. When there are multiple development sites and numerous manufacturing sites, this becomes especially challenging. In order to help manage this in an efficient manner, we have established a PAT SME network with representation from the Manufacturing and the Development organizations. I will briefly introduce how this team facilitates PAT activities and attempts to add value to both organizations.
  • Corning®バイオプロセスの最新培養技術とシングルユース技術導入ポイントセミナー
    Corning®バイオプロセスの最新培養技術とシングルユース技術導入ポイントセミナー
    コーニングインターナショナル株式会社  ライサイエンス事業部 石渡 孝至 Mar 13 2019 6:00 am UTC 60 mins
    バイオロジクスの大量培養を具現化に向け、幹細胞、癌細胞、タンパク発現系細胞の基礎的培養技術を示しながら、弊社のシングルユース品質規格(ISO / GMP / QMS)について概説します。

    <セミナーのポイント>
    細胞治療・遺伝子治療を中心にバイオプロセス開発が急速に進められております。幹細胞、癌細胞や標的タンパクを発現する細胞による再生医療・遺伝子治療を具現化する際に、最も大きな懸案事項となりますのが質、量そしてコストの問題があります。 そこでコーニングは、安全、安価かつ簡便な最新シングルユース技術についてレギュレーション、導入事例によるマーケットトレンドを示しながら、セルカルチャー(可溶性マイクロキャリア、撹拌・振盪容器、多段型培養容器)、閉鎖系チュービング(プレアッセンブル、無菌接続)、パッケージング(回収 / セルバンク)、データインテグリティ(バーコードによるトレーサビリティ管理)、品質規格(成型施設環境、BSE/TSE、発熱物質(Pyrogen)、USPクラスⅥ原料樹脂規格 / 滅菌保証レベル / エンドトキシン規格 / QC試験)および品質に関するドキュメンテーションサポート(バリデーションガイド)に関する情報を概説します。
  • Integrity Assurance for SUS: End-User Perspective
    Integrity Assurance for SUS: End-User Perspective
    Charlotte Masy, Project Manager in global support GSK vaccinés and Donald Young, Sr. Product Manager at Thermo Fisher Scienti Mar 14 2019 9:00 am UTC 75 mins
    Single Use technologies are more and more used close to final product leading to increase concern related to integrity. In this article we would like to share supportive data affecting integrity. Defect mode analysis has allowed us to build a risk assessment and a strategy on integrity. This strategy is very important for critical applications when single use are used after last sterile filtration or in process no sterile filtration is possible.
    Several case studies supporting our approach will be shared showing the importance of addressing integrity in the context of use and taking all technical aspect into consideration. Finally, we will also present data analyzing the effect of such a strategy on lowering defect occurrence .
  • Understanding the Propensity of Sequence Variants During Cell Line & Culture...
    Understanding the Propensity of Sequence Variants During Cell Line & Culture...
    Dr. Lisa Marzilli, Associate Research Fellow and group leader Mass Spectrometry at Pfizer, USA Mar 18 2019 3:00 pm UTC 75 mins
    Sequence variants (SVs) are protein isoforms that contain one or more unintended amino acid substitutions. They can arise at a single amino acid site due to a genetic (RNA/DNA) mutation or at multiple amino acid locations, potentially due to translational errors, also referred to as misincorporations. The ability to detect SVs in protein biotherapeutics is critical due to their potential impact on structural/functional characteristics, safety and efficacy. Trypsin peptide mapping with liquid chromatography-ultrahigh resolution tandem mass spectrometry (LC-MS/MS) provides the ideal workflow for the detection, identification, and relative quantitation of both genetic and translational SVs. LC-MS/MS complements next-generation sequencing (NGS) of product cDNA and amino acid analysis (AAA) of cell culture medium during clone selection and process optimization in providing sensitive, comprehensive screening to strategically prevent/minimize SVs and ensure high product quality.

    The occurrence of genetic SVs was evaluated using Sanger sequencing and LC/MS. In this work, mAbs with known high and low-level genetic SVs were studied at various cell culture conditions including scale, process and cell age. While scale and process had no significant impact on genetic SV levels, low-level SVs were found to decrease with cell age whereas high level SVs remained constant.

    Multiple cell culture process options and the final process conditions are analyzed via LC-MS/MS prior to lock-down of the manufacturing process. Additionally, the cell culture medium (days in culture) for all small scale, pilot and clinical batches are analyzed by AAA to ascertain amino acid nutrient levels, which provides indirect monitoring of possible misincorporation situations. For mAbs with confirmed misincorporations, AAA and LC-MS/MS-peptide mapping results primarily correlated with amino acid nutrient depletion.
  • Transformational Science: Moving from Challenges of High Concentration Protein..
    Transformational Science: Moving from Challenges of High Concentration Protein..
    Sachin Dubey, Ph.D., Head of Formulation and Analytical Development at Glenmark Pharmaceuticals SA Mar 19 2019 3:00 pm UTC 75 mins
    TRANSFORMATIONAL SCIENCE: MOVING FROM CHALLENGES OF HIGH CONCENTRATION PROTEIN FORMULATIONS DEVELOPMENT TO MEET THE NEEDS OF HIGH POTENT BISPECIFICS
    Monoclonal antibodies (mAbs) have significantly contributed in the treatment of oncological and immunological disorders over last two decades. Next advancement in this line is the introduction of bispecific antibodies – molecules which can bind to two different receptors at the same time. Engaging T-cells to target tumor cells and eventually killing tumor cells have been clinically demonstrated by such bispecific antibody. Traditionally one of the key challenge for developing mAbs is to administer high quantities of mAbs, on the other hand bispecific antibodies are extremely specific and more efficient, which makes them highly potent – leading to a reduced dose. This turns the focus from developing high concentration formulations for mAbs to the development of low concentration formulations. Scientific challenges are of very different nature with surface adsorption being the key challenge; during drug product manufacturing as well as during clinical dosing a protein molecules encounters various different surfaces and preventing/controlling adsorption on any of these surfaces is important. Analytical methods are also required to be adapted for reliable low concentration measurement for the drug product as well as the diluted preparation for infusion in clinic.
  • mAb Industry in China: Biosimilars vs. Innovative Biologics
    mAb Industry in China: Biosimilars vs. Innovative Biologics
    Dr. Joe X Zhou is the CEO Walvax Bio Group & Floris D Smet, Director of Field Marketing, Sarotrius China Mar 21 2019 8:00 am UTC 75 mins
    Following patent cliffs for Erbitux, Rituxan, Sandosta_n and several big blockbusters, Herceptin, Avastin are now among the next biosimilar targets. This is creating huge potential for biosimilars, prompting innovators to shift their focus to target more emerging markets which remain untapped for many companies. In this presentation, Joe will be sharing with you his vision of the biosimilars market with a focus on China. He will also discuss key considerations for mAb and biologics therapeutic development, providing a broad overview of challenges and opportunities presenting in the market.
     
    1.        Landscape changes of mAb therapeutics
    2.        New targets and process/manufacturing innovation
    3.        Key consideration of mAb industry in China
    4.        Case study: Development strategies of PD-1 mAb as anti-tumor therapeutics in China for global market
  • Navigating new frontiers: Ways to find space in the future RA market
    Navigating new frontiers: Ways to find space in the future RA market
    Helen Parfitt, Head of Therapy Watch, Research Partnership, Mariel Metcalfe and Mark Hollis, Research Partnership Mar 21 2019 3:00 pm UTC 75 mins
    Rheumatoid arthritis (RA) has been a major growth driver for the pharmaceutical industry over the last 15 years, led by AbbVie’s blockbuster anti-TNF inhibitor treatment Humira (adalimumab).

    The emergence of low-cost biosimilar versions of Humira and the new janus kinase (JAK) inhibitors, are shaking up a once-stable market.

    Although there are only two drugs in this class available in the region – Eli Lilly’s Olumiant (baricitinib) and Pfizer’s Xeljanz (tofacitinib) – this is not likely to be the case for much longer, as several other candidates reach late-stage development.

    Analysis of Therapy Watch data, a real-time' syndicated market tracking tool from Research Partnership, shows that JAK inhibitors have already made a strong impression in the European RA market, where their convenient oral administration advantage may override cost considerations that would otherwise favour biosimilar uptake.

    This pharmaphorum webinar, held in conjunction with Research Partnership, will use the latest intelligence from both physicians and patients to look at emerging trends in the RA market, how these will shape the RA market of tomorrow and how companies can best position themselves for future success.

    This webinar will provide an opportunity to interact with the panel about how companies can best harness the potential of this increasingly complex, but highly rewarding, market.

    Topics to be covered include:

    The European RA market
    Current status and market situation of JAK inhibitors (key EU5 countries)
    Uptake curve of JAKs compared to other new entrants and biosimilars
    Profile of physicians prescribing JAKS
    Country differences
    The future of new classes of JAK inhibitors
  • Extractables and Leachables have been used interchangeablely for too long. Are w
    Extractables and Leachables have been used interchangeablely for too long. Are w
    Ken Wong, Deputy Director at Sanofi Pasteur and Diego Zurbriggen, Technical Account Manager at West Pharma Mar 25 2019 2:00 pm UTC 75 mins
    Title: Extractables and Leachables have been used interchangeablely for too long. Are we still confused?
    Presenters: Ken Wong, Deputy Director at Sanofi Pasteur and Diego Zurbriggen, Technical Account Manager at West Pharma

    Description:TBA
  • FROM EARLY STAGE TO LATE STAGE DEVELOPMENT: HOW TO CHARACTERIZE A PERFUSION-...
    FROM EARLY STAGE TO LATE STAGE DEVELOPMENT: HOW TO CHARACTERIZE A PERFUSION-...
    Perrine Rouel, Janssen Pharmaceutical Companies of Johnson & Johnson and Tom Jeffery, Sartorius Stedim Biotech Mar 27 2019 3:00 pm UTC 75 mins
    FROM EARLY STAGE TO LATE STAGE DEVELOPMENT: HOW TO CHARACTERIZE A PERFUSION-BASED VACCINE PRODUCTION PROCESS USING QBD?
    The biopharmaceutical industry is known for its long time-to-market and for requiring large resources and time investment for product development. The type of activities required at the start of a biopharmaceutical product development focus mainly on designing a suitable process for manufacturing as rapidly as possible material to be tested in pre-clinical and clinical trials. This is followed, upon success in early clinical trials, by a process optimization phase, which aims at increasing yields while reducing costs-of-good. Moving on towards late stage development, the manufacturing process needs to be characterized, meaning that its robustness to produce the desired product quality when operated within certain process ranges needs to be demonstrated. This phase requires large numbers of development batches using elaborate analytical methods and advanced statistics, in order to fully study the relations between the manufacturing process and product quality.
    Janssen Vaccines has transitioned over the last 3 years from early stage process development to full late stage development programs. In this presentation, we present the implications of such a transition, with the case-study of the QbD-based characterization of a perfusion-based PER.C6® cell culture process for Adenovirus vaccine production at Janssen Vaccines.
  • Introducing Chromassette®, a modular chromatography platform enabling next-gener
    Introducing Chromassette®, a modular chromatography platform enabling next-gener
    Ping Huang, Director, Head of DS BioProcesses, OED, Abbvie at Redwood and Masayoshi Nagaya, Sr. Global Technology Manager Apr 4 2019 5:00 pm UTC 75 mins
    Title: Introducing Chromassette®, a modular chromatography platform enabling next-generation bioprocess purification.

    We will introduce Chromassette® and an application example of an integrated rapid single pass process from harvest to purified bulk, a concept demonstrated by AbbVie. Chromassette is a stackable, single-use and pre-packed chromatography cassette with a supported bed, addressing the current key challenges in manufacturing. Chromassette enhances the separation capabilities of chromatography resins and combines it with the convenience of a modular cassette.
  • 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 Apr 8 2019 8:00 am UTC 75 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.
  • Case-by-Case Assessment of Bioburden (CCAB): A Comprehensive Approach to Assess
    Case-by-Case Assessment of Bioburden (CCAB): A Comprehensive Approach to Assess
    Dr Friedrich von Wintzingerode, Senior Manager, Global Analytical Science & Technology (gASAT) Microbiology, Global QC bei Ro Apr 9 2019 8:00 am UTC 75 mins
    Large scale Production of Biologics is susceptible to microbial contamination because many manufacturing steps occur under non-sterile conditions in aqueous systems at ambient temperature or 2-8 °C under substantially neutral pH conditions. Regardless of where in the Drug Substance (DS) manufacture (manufacture of the Active Pharmaceutical Ingredient), or Drug Product (DP) manufacture (manufacture of the Final Drug, e.g. formulated mAbs filled in vials or syringes) they occur, microbial contaminations can have a significant impact on product quality and patient safety. Even after bioburden removal by 0.2 µm filtration subcellular microbial components like toxins, lipopeptide/lipoproteins, flagellin, bacterial and fungal DNA, cell wall polysaccharides, extracellular proteases or endoglycosidases remain in the product. Those microbial components potentially lead to toxic, allergic or inflammatory responses in humans or product degradation or modification. The CCAB approach described here enables a comprehensive assessment of these risks.
  • Application of Multivariate Data Analysis for Process Diagnostic and Root Cause
    Application of Multivariate Data Analysis for Process Diagnostic and Root Cause
    Hossein Sahraei, Data Scientist, Sanofi Pasteur Apr 10 2019 2:00 pm UTC 75 mins
    The utilization of Multivariate Data Analysis (MVDA) techniques at Sanofi Pasteur, Toronto site has demonstrated innovative capabilities for improved process understanding, control and diagnostics. Examples from several successful and high impact applications will be presented. These examples cover the application of MVDA techniques in multivariate process control, root cause investigations and process analytical technology (PAT). The areas of application include fermentation, downstream purification and product formulation stages.
  • Principles for the Development of Latex Enhanced Immunoassays 
    Principles for the Development of Latex Enhanced Immunoassays 
    Vasilis Tsaousis, PhD., Medicon Hellas Apr 11 2019 4:00 pm UTC 75 mins
    Latex enhanced immunoassay reagents can be adapted to automated biochemistry bio-analyzers ,equipment available in every modern biochemistry laboratory. Combining existing knowledge in the areas of antibody development and bead conjugation these reagents are suitable for the determination of proteins in patient samples. Their use can override the need for specific and expensive equipment necessary to perform these tests in the past. This talk will focus on the methods we could follow in the design of these reagents, the optimization of crucial factors in the development phase and the validation procedures to reach the expected analytical performance.