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Life Sciences

  • Introducing the CellStreamTM System, A Highly-Sensitive, 7-Laser Flow Cytometer
    Introducing the CellStreamTM System, A Highly-Sensitive, 7-Laser Flow Cytometer Robert Smith-Mccollum and Christine Probst Recorded: Jul 18 2018 40 mins
    MilliporeSigma is excited to launch the new CellStreamTM benchtop flow cytometry system, a highly-customizable, highly-sensitive 7-laser flow cytometer. Its unique optics system and design provides researchers with unparalleled sensitivity and flexibility when analyzing cells and submicron particles. Within the CellStreamTM system, the Amnis® time delay integration (TDI) and camera technology rapidly captures low resolution cell images and transforms them into high-throughput intensity data. Researchers acquire the intensity data they are accustomed to from traditional flow cytometers, but with greater fluorescence sensitivity. Join us in this webinar to take a deeper look inside the instrument design, system performance and software of this exciting new system.
  • Key components of a comprehensive program for the management of single use techn
    Key components of a comprehensive program for the management of single use techn John Maguire, Shire & Donald Young Thermo Fisher Recorded: Jul 18 2018 74 mins
    As a result of the increased adoption of single-use technologies (SUTs) in biotech manufacturing, companies need to develop and implement programmatic approaches for the management of these systems under regulatory compliance. This webinar discusses the key aspects of such programs, with emphasis on collaboration with suppliers, cost management, as well as practical insights about the use of SUTs.
  • Proficiency Testing Portal Training
    Proficiency Testing Portal Training Jennifer Duhon Recorded: Jul 12 2018 17 mins
    We have taken your feedback shared with us over the years and used this to help improve our service to you. With this new portal, you will find new features including your methods now saved as default, graphical reports, the option to trend your data, as well as the ability to expand and collapse your items on the data entry screen which will allow for quicker loading times. This presentation will go through each feature step by step. If you could like to skip straight to how to enter data, please go to slide 34.
  • How to accelerate your innovation pipeline using Social Impact Investments
    How to accelerate your innovation pipeline using Social Impact Investments Rosemarie Truman from The Center for Advancing Innovation Recorded: Jul 12 2018 45 mins
    Social Impact Investment brings together capital and experience from the public, private and non-for-profit industries to achieve specific social objectives. The return of these investments is measured typically by the social outcomes achieved.

    The Centre of Advancing Innovation is a public-private partnership non-profit focused on identifying breakthrough inventions hidden in portfolios, to maximise investor returns and commercial success. Research performed by the group has highlighted that Social Impact projects accelerate innovation, and result in higher returns.

    In this webinar, Rosemarie Truman, CEO and Founder of CAI will be discussing the positive implications of choosing social impact projects for your business, including:

    - Why they accelerate innovation
    - How these projects can increase your potential investment opportunities for the future
    - The influence on the future funding of projects.
  • Development and Manufacturing of Recombinant Nanoparticle Vaccines
    Development and Manufacturing of Recombinant Nanoparticle Vaccines Atin Tomar, President of CPL Biologicals & Amelie Boulas Of Sartorius Stedim Recorded: Jul 12 2018 67 mins
    A recombinant vaccine technology platform based on highly purified, properly-folded protein antigens in stable well-defined Nanoparticles, enabling efficient and safe manufacture of vaccines against highly pathogenic targets. Nanoparticles are intrinsically immunogenic, producing both durable neutralizing antibodies and cellular immunity. The platform can be utilized for rapid response to potential pandemics as the time from identification of relevant viral gene sequence to final GMP drug product ready for human studies has been demonstrated to take less than 4 months for multiple vaccines.
    The GMP drug substance manufacturing process for the platform largely utilizes single-use technologies. Single-use-technologies and recombinant platform enables the utilization of same manufacturing facility for multiple products with rapid change-over.
  • Introduction to PharmaPendium: Leveraging FDA and EMA drug approval data
    Introduction to PharmaPendium: Leveraging FDA and EMA drug approval data Sherry Winter, PhD Recorded: Jul 11 2018 56 mins
    NOTE the date change.
    Learn how comparative information from FDA and EMA drug approval documents supports critical drug development decisions
  • Object Storage. What it Solves & Why it’s Better for Your Data at Scale.
    Object Storage. What it Solves & Why it’s Better for Your Data at Scale. Mike McWhorter, Senior Technologist, Western Digital Recorded: Jul 10 2018 25 mins
    Most have heard about object storage, but what problem is it solving, and how does it compare to other storage solutions like SAN or NAS? If these are questions you’ve asked yourself this webinar is for you! (Hint: The problem Object Storage solves is scalability.)

    Join Senior Technologist Mike McWhorter as he explains how Object Storage differs from SAN, NAS and distributed file systems, the unique technological features which make object storage ideal for archiving, accessing or protecting data (especially unstructured data), and how different industries are using Object Storage today.

    Register today to watch live or for the on-demand recording.
  • Proficiency Testing Portal Training
    Proficiency Testing Portal Training Jennifer Duhon Recorded: Jul 10 2018 17 mins
    We have taken your feedback shared with us over the years and used this to help improve our service to you. With this new portal, you will find new features including your methods now saved as default, graphical reports, the option to trend your data, as well as the ability to expand and collapse your items on the data entry screen which will allow for quicker loading times. This presentation will go through each feature step by step. If you could like to skip straight to how to enter data, please go to slide 34.
  • Soft Tissue Cancer & IHC
    Soft Tissue Cancer & IHC Jeff Gordon Recorded: Jun 29 2018 65 mins
    Soft tissue tumors are a broad group of neoplasms that involve the connective tissue of the body. Each year, over 13,000 people in the US are diagnosed with soft tissue sarcomas and over 5,000 people succumb to the malignancy. Because soft tissue sarcomas are very ambiguous and amorphous, many time sarcomas are classified as an uncertain type. Advances in immunohistochemistry as well as the utility of novel markers such as TFE3, TLE1, MyoD1, and MUC4 have aided pathologists in classifying these soft tissue tumors. This discussion will cover the key facts and statistics about soft tissue tumors and what role IHC plays in these difficult diagnoses.
  • Multiplexed immunofluorescence and digital image analysis for clinical use
    Multiplexed immunofluorescence and digital image analysis for clinical use Mehrnoush Khojasteh, PhD & Lei Tang, PhD Recorded: Jun 28 2018 63 mins
    There is an ever increasing need to understand the role of the Tumor Microenvironment (TME) in Cancer Immunotherapy. In this webinar, Drs. Lei Tang, PhD and Mehrnoush Khojasteh,PhD of Roche Tissue Diagnostics (Ventana Medical Systems, Inc.), present their work on multiplex immunofluorescence staining and digital pathology analysis in a CAP/CLIA certified laboratory. Multiplexed immunohistochemistry (IHC) enables the spatial characterization of TME immune cells and tumor cells by detecting multiple biomarkers while preserving tissue morphology. Co-expression of multiple biomarkers and relative spatial relationships requires whole slide digital pathology image analysis algorithms that are tailored to individual assays and their intended uses. The process described in this presentation demonstrates how multiplexing and digital pathology enable biotech and pharmaceutical research and development teams to explore the potential medical value of specific biomarkers,
  • CRISPR Protein Products
    CRISPR Protein Products Yanfang Jiang, Ph. D. Recorded: Jun 28 2018 32 mins
    MilliporeSigma is a pioneer in commercially offering targeted genome editing tools. With its 14-year experience in the first generation of genome editing tools such as TargeTron® and Zinc Finger Nuclease, MilliporeSigma has emerged as a prominent leader in the development of CRISPR systems, the most flexible and efficient genome editing technology thus far developed. CRISPR-based DNA integration patents have been granted to MilliporSigma in seven regions including Australia, Canada, the European Union, Singapore, Israel, South Korea, and most recently in China. The MilliporeSigma CRISPR portfolio consists of an array of CRISPR products, in both the plasmid, RNA, protein, and lentiviral formats. MilliporeSigma is also the first commercial provider to offer both pooled and arrayed whole human genome CRISPR libraries.

    In this webinar, we will give an introduction to our current CRISPR protein products, including SpCas9 (CAS9PROT), Cas9-D10A nickase (CAS9D10APR), high fidelity eSpCas9 (ESPCAS9POR), catalytically inactive dCas9-FLAG-biotin (DCAS9PROT), and FnCas9 (FNCAS9PROT), focusing on specific enzyme characteristics of each protein and their potential applications for the research community.
  • Strategies to overcome Low Endotoxin Recovery using the conventional LAL assay
    Strategies to overcome Low Endotoxin Recovery using the conventional LAL assay Dr. Ruth Daniels, Janssen & Kevin L. Williams, BIOMÉRIEUX USA, Inc. Recorded: Jun 28 2018 63 mins
    Title: Strategies to overcome Low Endotoxin Recovery using the conventional LAL assay
    Presenter: Dr. Ruth Daniels, Janssen
    This presentation will discuss:
    - Endotoxin hold time studies to identify LER
    - In silico assessment of interfering factors and associated LER mitigation strategies
    - Case study: optimization of product-specific LAL assay to overcome LER

    Title: : Addressing LER at the root, with ENDO-RS® sample preparation (demasking) prior to endotoxin assay of choice
    Presenter: Kevin L. Williams, Senior Scientist Endotoxin - BIOMÉRIEUX
    Scientific studies have demonstrated that biologics typically containing protein in high concentrations and non-ionic surfactants, are likely to change the aggregate state of endotoxin in such a way that it is no longer accessible for detection with Factor C-based endotoxin detection methods (LAL and rFC). The ENDO-RS® endotoxin recovery method developed by Hyglos - a bioMérieux company, is a unique toolbox of dedicated reagents for demasking (recovering) endotoxin prior to detection, also for conventional LAL. This presentation covers the mechanism of LER, regulatory requirements, work principle of ENDO-RS, the demasking services of bioMérieux, as well as method application data.
  • How to make digital work in medtech
    How to make digital work in medtech Bryn Davies (Critical Insights), Lars U. Diemer (Agnitio), Markus Ott (Ascensia), Jerome d'Astros (Edwards Lifesciences) Recorded: Jun 21 2018 71 mins
    The rise of mobile devices and apps, not to mention the involvement of non-medical technology players, is creating a wave of irrevocable digital change for medtech.
    It’s transforming how the sector reaches and engages with its stakeholders and customers, and in doing so provides vital opportunities to reshape a company’s commercial model.
    But although the sector can lay claim to some key success stories with digital technology, there remain a number of roadblocks impeding real digital progress for medtech.

    In this webinar we will discuss key digital lessons for medtech from other healthcare sectors, steps to take for a successful digital transformation and how to ensure ROI from digital technology.
    The free webinar will also see our expert panel:
    •Explore the practical impacts of the new medtech business model
    •Re-think the customer experience for payers and HCPs
    •Learn how digital technology enables you to deliver more customer value – while powering commercial success
    •Find out how virtual engagement technologies can make it happen
    •See best practices and use cases from your peers
  • Platform tech development for biosimilar upscaling
    Platform tech development for biosimilar upscaling Dr Hung Fai Poon, President, QuaCell Biotech Ltd and Floris De Smet, Sartorius Stedim Biotech Recorded: Jun 21 2018 68 mins
    Discover strategies to move candidate molecules through development
    Building consistent, straightforward processes with low variability
    Exploring the possibility of using single use, high throughput bioreactors in the upscaling process
  • Systematic reviews with Embase and Mendeley
    Systematic reviews with Embase and Mendeley Xuanyan Xu, Embase Solution Marketing Manager; Max Dumoulin, VP of Institutional Offerings at Elsevie Recorded: Jun 20 2018 51 mins
    (details to be updated)

    - How to use PICO search form in Embase to build effective search for systematic reviews
    - How to use Index miner and Find similar records to support a complex search query building
    - How to use Mendeley for systematic review
  • Short Tutorial: Techniques for Harvesting Adherent Cells
    Short Tutorial: Techniques for Harvesting Adherent Cells Corning Life Sciences Recorded: Jun 18 2018 5 mins
    Harvesting your cells is an important step in maintaining healthy cultures. Good technique will lead to a healthy single cell suspension. There are many harvesting options depending on the cell line and application. In this video, we will discuss some tips/tricks to harvesting cells.
  • User Profiles Tutorial
    User Profiles Tutorial Kathleen Berryman Recorded: Jun 18 2018 4 mins
    A short tutorial showing how to create and use the user profiles feature in Cabells.
  • Manufacturing strategies for Biosimilar: A case of continuous capture
    Manufacturing strategies for Biosimilar: A case of continuous capture Solomon Alva, Biocon & Presented by Yvan Ruland, PhD, Technology Director, Asia/Pacific operations, Novasep Asia Recorded: Jun 15 2018 74 mins
    Presented By Solon Alva Antibody Purification Group Lead, Senior Scientific Manager, Biocon Research Limited
    Continuous manufacturing is an emerging technology in biopharmaceutical industry. The focus of this webinar is a case-study on the benefits of continuous Protein A capture on productivity, capacity utilization and buffer consumption. The potential challenges of adopting the technology such as its integration with cell culture and low pH incubation step has been discussed. There is promise of this technology as an effective platform, and potential of additional savings when considering new generation Protein A resins and in-line concentration technologies.
    Followed by Yvan Ruland, PhD, Technology Director, Asia/Pacific operations, Novasep Asia
  • Master and power your chemical searchers with Reaxys and MarvinJS
    Master and power your chemical searchers with Reaxys and MarvinJS Aurora Costache, ChemAxon; Derrick Umali, Elsevier; Prima Sung, Elsevier; Recorded: Jun 14 2018 61 mins
    Marvin JS, produced by ChemAxon, is a state-of-the-art chemical editor that combines the chemical knowledge of MarvinSketch with the JavaScript-based browser technology. Based on the feedback from our users we have updated MarvinJS to enable easier and faster generation of structure queries.

    In this webinar, you will improve your structure and reaction searching capability via:
    •Learning the differences between substructure searching vs substitution count
    •Drawing common functional groups via keyboard input
    •Using Reaxys generics and abbreviated groups to direct result sets
    •Using merge reactants feature
    •Learning additional query functions
    oAtom Locking
    oReaction Manual Mapping
    oStructure Templates
    oOther tips and tricks
  • Fully continuous biosimilar manufacturing framework: A case study
    Fully continuous biosimilar manufacturing framework: A case study Samir Varma, Head of Manufacturing, Enzene Biosciences and Lotta Molander, Global Product Manager, GE Healthcare Recorded: Jun 14 2018 68 mins
    Biologics manufacturing has traditionally been in fed batch mode for the last 2 decades. During the early stages of biologics manufacturing, lower cell line productivity and product instability necessitated the usage of perfusion technology. As productivity increased and mabs became more stable, perfusion was replaced by fedbatch technology, as they were simpler to scale up. However, during the past 2-3 years, the perfusion technology is making a comeback due to the novel continuous chromatography technology. Connecting the perfusion bioreactor to the continuous chromatography system creates a continuous flow of drug substance and promises the following advantages

    The facility footprint for a continuous manufacturing plant would be substantially lower. Our calculations show that a 10-fold reduction in bioreactor size is possible with continuous bioprocessing. So the capacity of a 2000L Fed batch Bioreactor can be achieved by a 200L continuous bioreactor. This reduces the capex by about five fold.
    Consumption of media per amount of DS produced is the same for fedbatch and perfusion, although the cost per liter might be lower for perfusion as it could be a more diluted version of the fedbatch media ,
    Another major cost in bioprocessing is the Protein A resin. A significantly smaller Protein A column could be used in the continuous process and the utilization could be maximized by this strategy.
    As the process is more dynamic in continuous, automation and in-line analytical tools are essential for the successful implementation.
    Enzene Biosciences is on the forefront of the development of the continuous bioprocessing. We are in the processing of building a cGMP plant that would have a fully integrated continuous bioprocess. We have already complete a proof of concept studies in pilot scale (50L)
  • Preview of USP’s Informational Chapter , Guidelines on the Endotoxins Test
    Preview of USP’s Informational Chapter , Guidelines on the Endotoxins Test Karen Zink McCullough of MMI Associates & Kevin L. Williams of BioMérieux Recorded: Jun 11 2018 61 mins
    Title: Preview of USP’s Informational Chapter, Guidelines on the Endotoxins Test
    Presenter: Karen Zink McCullough, MMI Associates
    The retirement of FDA’s 1987 Guideline on LAL testing left a number of gaps in the written body of knowledge
    on LAL testing. Some of these gaps include: Guidance on RSE:CSE standardization, Guidance on Training,
    Guidance on OOS test results, and Calculation of Endotoxin Limits. The proposed chapter, that will appear in the
    July/August issue of Pharmacopeial Forum, provides information and recommendations on these topics and
    more. This Webinar will provide an overview of the contents of this new informational chapter.

    Title: Regulatory Compliance of Alternative Methods
    Presenter: Kevin L. Williams, BIOMÉRIEUX
    Recombinant Horseshoe Crab Factor C (rFC) tests are endotoxin-specific alternatives to Limulus Amebocyte Lyste
    (LAL). The United States Food and Drug Administration included rFC in their Guidance for Industry in 2012 and in
    2016 the European Pharmacopoeia followed suit. Recently, the Japanese Pharmaceutical and Medical Device
    Agency published a collaborative study demonstrating equivalence between rFC and LAL. This presentation will
    provide an overview of how alternative method validation of rFC methods is conducted in accordance to USP
    chapters < 1225 > and < 85 >.
  • Calls for Papers Tutorial
    Calls for Papers Tutorial Kathleen Berryman Recorded: Jun 10 2018 2 mins
    A short tutorial showing the calls for papers feature in Cabells Whitelist
  • Cabells Metrics Tutorial
    Cabells Metrics Tutorial Kathleen Berryman Recorded: Jun 10 2018 6 mins
    A short tutorial on what metrics Cabells offers and what each one means.
  • Search and Advanced Search Tutorial
    Search and Advanced Search Tutorial Kathleen Berryman Recorded: Jun 10 2018 6 mins
    A short tutorial on how to use the search and advanced search features in Cabells.
  • More on the Unique Selectivity of Ionic Liquid GC Stationary Phases
    More on the Unique Selectivity of Ionic Liquid GC Stationary Phases Len Sidisky Recorded: Jun 7 2018 55 mins
    Over the years, extensive evaluations of columns manufactured with ionic liquid stationary phases have occurred. Their main strength was discovered to be unique selectivity. This selectivity is made possible due to the various combinations of cations and anions that are available along with spacer groups used to prepare these germinal
    dicationic phases. Columns prepared with di- or tricationic phases have the ability to perform many of the same applications as columns made with polysiloxane polymer or polyethylene glycol stationary phases of similar polarity, but with slight elution order changes. Many times this results in increased resolution and/or shorter run times. This webinar will compare and contrast the selectivity of the ionic liquids stationary phases with
    traditional phases of similar or like selectivity’s for applications with a
    variety of different sample types from a number of industries including
    petrochemical, pharmaceutical, environmental, food and beverage and flavor and fragrance.
  • HPLC Method Development in One and a Half Days Using the Selectivity Concept
    HPLC Method Development in One and a Half Days Using the Selectivity Concept Dr. Frank Michel, Analytical & Chromatography Scientific Advisor, Merck KGaA, Darmstadt, Germany Jul 24 2018 6:00 am UTC 75 mins
    Modern HPLC technologies such as UHPLC, monolithic silica or Fused-Core™ particles provide superior separation efficiency and resolution of peaks. But in general resolution is more strongly impacted by selectivity which in turn can be affected by different stationary bonded phases. This presentation will discuss the choice of RP HPLC column chemistries such as RP-Amide, Phenyl, Pentafluorophenyl (F5) or Cyano which can provide alternative selectivities to traditional C18. It will compare their different retention mechanisms and highlight an approach to develop HPLC method within one and a half days.
  • High-Throughput Microfluidic Platform for Culture of 3D-Kidney Tissue Models
    High-Throughput Microfluidic Platform for Culture of 3D-Kidney Tissue Models Henriëtte Lanz, Ph.D. Jul 24 2018 5:00 pm UTC 75 mins
    Drug toxicity remains a major issue in drug discovery and stresses the need for better predictive models. Here, we describe the development of a perfused renal proximal tubule cell (RPTC) model in Mimetas’ OrganoPlates® to predict kidney toxicity. The OrganoPlate® is a microfluidic platform, which enables high-throughput culture of boundary tissues in miniaturized organ models. In OrganoPlates®, ECM gels can be freely patterned in microchambers through the use of PhaseGuide technology. PhaseGuides define channels within microchambers that can be used for ECM deposition or medium perfusion. The microfluidic channel dimensions not only allow solid tissue and barrier formation, but also perfused tubular epithelial vessel structures can be grown. The goal of developing a perfused RPTC model is to reconstruct viable and leak-tight boundaries for performing cytotoxicity, as well as transport and efficacy studies. Human RPTC (SA7K clone, Sigma) were grown against an ECM in a 3channel OrganoPlate®, yielding access to both the apical and basal side. Confocal imaging revealed that the cells formed a tubular structure. Staining showed tight junction formations (ZO-1), cilia pointing into the lumen (acetylated tubulin) and correct polarization with microvilli on the apical side of the tubule (ezrin). Tightness of the boundary over several days was shown by diffusion of a dextran dye added to the lumen of the tubule. Addition of toxic compounds resulted in disruption of the barrier which could be monitored in time. The time point of loss of integrity corresponds with the concentration and the toxic effect of the compound. Furthermore, fluorescent transport assays showed functional transport activity of in- and efflux transporters. The 3D proximal tubules cultured in the OrganoPlate® are suitable for high-throughput toxicity screening, trans-epithelial transport studies, and complex co-culture models to recreate an in vivo-like microenvironment.
  • How to create a 5-year M&A plan for dealing with patent cliffs
    How to create a 5-year M&A plan for dealing with patent cliffs Jurgen Vollrath, President at Exponential Technology Counsel Jul 25 2018 3:00 pm UTC 60 mins
    A ‘Patent cliff’ describes a severe drop in revenue once the patent for a company’s leading product expires. The sharp revenue decline is a result of competitors being able to start developing and selling the product, often at a much lower price.

    As US biopharmaceutical company Celgene struggles to get regulatory approval from the FDA, the company is facing major market, shares and revenue losses, and is facing a phenomenal patent cliff. Furthermore, research from EvaluatePharma reports that an estimated $250 billion in projected sales is at risk between 2018-2024 as many drugs lose exclusivity.

    When it comes to acquisitions, the effects of a dwindling patent term can severely impact the value of your company. So how do you create 5-year plan to prepare for an inevitable patent cliff? We are very excited to welcome back Jurgen Vollrath, President of Exponential Technology Counsel, and customer of PatSnap. ET Counsel, advise clients on IP strategy & business alignment to ensure the most successful M&A and exit outcomes.

    In this webinar, Jurgen will be discussing:

    - Risk vs. reality when it comes to patent cliffs
    - How to create a 5-year M&A plan for your organisation
    - How to find potential acquisition targets
    - Predicting the potential impact a patent cliff could have on your business.
  • Building a Better VDR
    Building a Better VDR Brian Nickel, Sales Engineer @ Box; Riju Khetarpal, Managing Director @ Box; Bijon Mehta, Financial Services @ Box Jul 25 2018 4:00 pm UTC 60 mins
    The Virtual Data Room (VDR) has become an essential tool for sharing time-sensitive data and intellectual property.

    Join us to learn how to build a better VDR that isn't held back by outdated UI, poor mobile capabilities, missing integrations and lack of collaboration tools.

    Here's what you'll find out:
    -How using Box for VDRs accelerates deal cycles — M&A term sheets, joint ventures, cross-licensing and other collaborations
    -Use cases from Life Sciences and Financial Services
    -How systems integrator MSI uses Box to build VDRs for clients
  • Subvisible Particles Matter, Developments in Regulations and Low Volume Methods
    Subvisible Particles Matter, Developments in Regulations and Low Volume Methods Dr Satish K Singh, Lonza Jul 26 2018 2:00 pm UTC 75 mins
    The need to measure and characterize proteinaceous particles in therapeutic protein products has been emphasized by regulators. USP is a new chapter that addresses the limitations of USP for therapeutic proteins in measurement of subvisible particles. USP is a guidance chapter addressing the task of characterization of particles with the emphasis on proteinaceous particles. Furthermore, regulatory authorities require that sponsors understand the submicron particle size range of the products also. This article will look at latest regulatory developments, key aspects of the measurement of subvisible and submicron particles in biotherapeutics, as well as the utility of low volume methods.
  • Next generation processes: What model works the best in Asia?
    Next generation processes: What model works the best in Asia? Ravishankar Kasturi, Reliance Life Sciences & Marc Bisschops, Director Continuous Bioprocessing - SLS Aug 9 2018 5:00 am UTC 75 mins
    Compare and contrast the available full scale processing technologies, and discover what works the best for manufacturing next generation therapeutic products in Asia.

    Biologics are complex and hard to make, which helps to explain why biotech manufacturing plants are huge and expensive to build. To be competitive, manufacturing must be efficient and cost-effective and should brainstorm economical ways to manufacture biologics.

    Biosimilars are a cost competitive market. Pricing may have a direct impact on market share, and return on investment. The market for biologics, including approved and in pipeline like ADCs, antibodies & antibody fragments present both tremendous opportunity and challenge. Challenges necessitates looking beyond the current platform philosophy for how to modify the process with a goal to increase overall productivity in a flexible manner.

    The current processing paradigm of large manufacturing facilities dedicated to single product production is no longer an effective approach for manufacturing next generation therapeutic products in Asia.

    Cost Effective Biosimilars Manufacturing may include
    Single-use technologies and continuous upstream processes have proven to be cost-efficient options
    Aspects of continuous manufacturing in both upstream and downstream manufacturing are being incorporated thereby increasing yields through a combination of longer production run times, more stable and higher secreting cell lines
    Technologies enabling high productivity, right-sized, small footprint, continuous, and automated operations are being evaluated.
    Adaptive control techniques are set to minimize development timelines and enhance process robustness
    Partnerships will continue to transform biosimilars industry. In order to gain access to developed markets, Indian biosimilar manufacturers are partnering with multiple local established manufacturers and big pharmaceutical companies
  • Mixed mode Chromatography in Purifying biologics - Overview
    Mixed mode Chromatography in Purifying biologics - Overview Vivek Halan Zumutor Biologics Pvt Ltd, Bangalore, India Aug 13 2018 9:30 am UTC 75 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.
  • Introducing Embase French Local Literature Module
    Introducing Embase French Local Literature Module Yvonne van de Vrede, Embase Product Manager Aug 15 2018 2:00 pm UTC 60 mins
    Literature is one of the essential sources to identify high quality 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. Currently, the local, non-English content sources is not available in most international literature databases, therefore screening, reviewing and monitoring this type of literature costs extra time, money and creates an additional compliance risk.

    In this webinar, Embase product manager Yvonne van de Vrede will discuss:
    -The challenges in Local Literature Monitoring process for pharmacovigilance, with a focus on the French market
    -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 Speaker:
    Yvonne van de Vrede has a degree in Molecular Pharmacology from the Free University in Amsterdam and a French MSc equivalence in Neurosciences from the University Paris VI. She started working for Elsevier in 2002 and has dealt with Embase in different roles: as an Index Quality Manager, a Thesaurus development manager, Account Manager and as a Project Manager. Since 2016, she has worked as Embase Product Manager for the content coverage and development, customer engagement and vendor relationship.
  • Is India Anywhere Closer to Implementing Continuous Bioprocessing
    Is India Anywhere Closer to Implementing Continuous Bioprocessing Narasimha Rao Nedunuri, CEO of CLONZ Biotech, and José Castillo, PhD, CTo and co-founder of Univercells Aug 16 2018 9:30 am UTC 75 mins
    Continuous processing has been widely employed in many biological manufacturing processes. In recent years it gained the momentum in the field of Biosimilar manufacturing due to an ever-increasing pressure for reduction in manufacturing costs.
    Potentially, the continuous processing offers Lower Cost of Goods, ease of scalability, and lower manufacturing footprint and hence became a topic of interest to many biosimilar players. Ongoing research on various new technologies for continuous operation, both in upstream and downstream processing may potentially be a game changer. Top on the wish list being, integration of all the multiple unit operations into a single continuous process with real time analytical tools.
    Though there are several challenges to develop and adapt continuous bioprocess, the magnitude of potential benefits are currently driving the research programs worldwide. India , being a significant global player in the biosimilar domain, currently making efforts to adapt these novel processes to make the drugs more cost effective.
  • Implementing CMC Strategies for scale-up operations in biologics manufacturing
    Implementing CMC Strategies for scale-up operations in biologics manufacturing Dr Anita Krishnan, Lupinand -Dr. Annu Uppal, Global Demo Lead and Advanced Workflow Specialist at SCIEX Aug 20 2018 9:30 am UTC 75 mins
    Biotechnological products are so complex, that manufacturing biologics which are both cost-effective and with best product quality, is a technical challenge. In the context of biosimilar manufacturing at each step, the sponsor should evaluate the extent to which there is residual uncertainty about the biosimilarity of the proposed product. Often there is remnant quality difference beyond the capability of process to address. In such instances, in-depth understanding of the process, impurities, analytical methods, the mechanism of action (MOA) of the drug substance and clinical relevance of any observed structural differences, will help in implementing novel CMC strategies. This talk will examine the elements of biopharmaceutical development that lead to successful licensure of biotherapeutics.
  • Evidence-Based Searching and Reporting the Search for Systematic Reviews
    Evidence-Based Searching and Reporting the Search for Systematic Reviews Farhad Shokraneh, University of Nottingham Aug 22 2018 2:00 pm UTC 75 mins
    Search methods are part of the research methods in systematic reviews and evidence synthesis. Running a robust search requires following the existing evidence in selection of databases and search filters, addition of limitations, and inclusion of a search methodologist in your team. While a proper evidence-based search protocol could reduce waste and increase value in systematic reviewing, proper reporting should make your search a piece of science.

    The search methods should be reported in a way that anyone who have access to the databases could repeat the search strategies and search methods (reproducibility) and retrieve the same or very similar search results both in terms of content and numbers (replicability). Following the minimum requirement for reporting the search, the team could produce an evidence-based search method that could be re-used by the readers. The team could also share the search results, as part of their research data, to prevent duplicate efforts for the researchers who want to update the review.

    About Speaker:
    Farhad Shokraneh studied Medical Library and Information Science for seven years and was a clinical librarian in an emergency department for a short time. He worked as a research fellow in Research Center for Pharmaceutical Nanotechnology for two years. Farhad later joined Cochrane Schizophrenia Group in University of Nottingham to manage the largest database of schizophrenia trials and to update over 320 Cochrane reviews. He is also a volunteer with 14 Cochrane groups.

    He ran his first systematic review search in 2004 and continued providing search and consultancy services to academic, clinical and policy making teams around the world for over 2,000 grant applications, clinical trials, economic evaluations, rapid reviews, scoping reviews, umbrella reviews, systematic reviews, overviews, health technology assessments, and clinical practice guidelines.
  • Material Understanding for Continuous Manufacturing of Solid Dosage Forms
    Material Understanding for Continuous Manufacturing of Solid Dosage Forms Dr Yifan Wang, regulatory research scientist, FDA CDER and -Dirk Leister, Head of the Application team Thermo Fisher Scienti Aug 23 2018 2:00 pm UTC 75 mins
    In continuous manufacturing of solid dosage forms, continued assurance of process performance and product quality is based on accurate and consistent flow of solid materials. Acknowledging the multidimensionality of material flow properties is often the first step to explore the material knowledge space. In addition, modular operations such as feeding and continuous blending often requires additional material testing for better understanding of process dynamics. As a key element of control strategy, tolerance of incoming material variations needs to be considered. The FDA’s Division of Pharmaceutical Quality Research is working to understand the impact of material properties and explore the material knowledge space for continuous manufacturing of solid dosage forms.
  • Project and Portfolio Management as a key tool to manage continuous improvement
    Project and Portfolio Management as a key tool to manage continuous improvement Gloria Gadea-Lopez, Ph.D.and Melvin Santos Sep 6 2018 2:00 pm UTC 75 mins
    Continuous improvement, risk mitigation and adherence to compliance rely on the successful execution of key initiatives aligned with an organization’s strategic imperatives. This article summarizes the Project and Portfolio initiatives at Shire’s Biologics manufacturing facility at Shire, Lexington, MA site. In addition to practical advice, the authors discuss the need for sound business processes, alignment with Finance and budget cycles, and play special attention to the importance of resource allocation and management.
  • Efficiency by Design- Case Study for a Hybrid Clinical Manufacturing Facility
    Efficiency by Design- Case Study for a Hybrid Clinical Manufacturing Facility Dr Sourav Kundu, Senior Director at Teva Pharmaceuticals Global Biologics R&D Sep 12 2018 2:00 pm UTC 75 mins
    Salient facility design aspects to achieve manufacturing efficiency
    Combining single use and stainless steel strategically creating a hybrid
    Risk-based approach to CQV- Reducing cost and tme
  • DSF and FTIR as methods for the identification and characterization
    DSF and FTIR as methods for the identification and characterization Marina Kirkitadze , Deputy Director, Head of Biophysics & Conformation Unit, Analytical R&D Biochemist & Kristen Kalbfleisch Sep 18 2018 2:00 pm UTC 75 mins
    The focus of this presentation is the application of Fourier Transform Infrared Spectroscopy (FTIR) and Differential Scanning Fluorimetry (DSF) methods to characterize vaccine components and their stability. Additionally, FTIR can be applied for the identification of final vaccine products, and DSF can be used to distinguish different formulations of vaccine candidates. These methods, when used in conjuction, provide valuable information regarding characterization and stability in the final stages of vaccine manufacturing.
  • Librarians’ Role in Evidence-Based Medicine Education for Healthcare Policymaker
    Librarians’ Role in Evidence-Based Medicine Education for Healthcare Policymaker Maylene Qiu, Systematic Review Coordinator and Clinical Liaison Librarian at Biomedical Library, University of Pennsylvania Sep 19 2018 2:00 pm UTC 60 mins
    The practice of evidence-based medicine (EBM) requires retrieving the knowledge from ever-increasing volume of literature. Librarians have supported EBM by offering information searching skills and various tailored training programs.

    While users’ needs constantly drive library’s teaching activities, customizable EBM teaching modules have been developed to respond to different needs of library's constituencies, particularly the policy makers within a university’s healthcare system. This involvement creates a new avenue to convey library’s value.

    About the speaker Maylene Qiu

    Maylene is responsible for developing and providing systematic review services for the patrons principally from the health sciences schools at UPenn and the UPenn Healthcare System. She also serves as the Clinical Liaison Librarian promoting evidence-based medicine information resources and services.

    Before coming to Penn, Maylene was Clinical Reference Librarian at Quillen College of Medicine Library at East Tennessee State University, where she provided services for the clinicians at the Point-of-Care.

    Prior to the library field, she has 10-year experience in pharmaceutical science obtained from working in China, Japan, and Canada. In that career, she commercialized several products in nutrition and agriculture. She earned a B.S. in Pharmaceutical Science from the Nanjing University of Chinese Traditional Medicine, and an M.A. in the Library and Information Science from the University of Wisconsin – Madison.
  • Multiplex immunoassay detection of Alzheimer’s disease biomarkers: Session 1
    Multiplex immunoassay detection of Alzheimer’s disease biomarkers: Session 1 Anthony Saporita, PhD Sep 26 2018 1:00 am UTC 75 mins
    Monitoring protein biomarkers in cerebrospinal fluid (CSF) of patients with Alzheimer’s Disease (AD) has been highly beneficial to understanding disease progression.  While several CSF biomarkers can reproducibly distinguish normal and diseased samples, CSF is a difficult biological fluid to obtain in research studies.  The need for blood-based biomarkers of AD has driven a continuous search for novel candidates.  Here we report the development of a multiplex immunoassay to quantitatively measure seven proteins present in both CSF and blood that are involved in neurological disease:  Neurogranin, TREM2, ApoE4, FABP3, Ferritin, angiogenin, and prion protein.  Notably, presence of the APOE4 allele is prominently associated with an increased risk for AD, in comparison to the APOE2 and APOE3 alleles.  Although these ApoE isoforms differ at only one or two amino acids, our assay distinguished ApoE4 with minimal cross-reactivity. Using this novel immunoassay, we measured these 7 biomarkers in CSF, plasma, and serum from AD patients and healthy controls.  Additionally, we developed an ultrasensitive Single Molecule Counting (SMCTM) assay for amyloid beta 1-42 (Aβ42).  This kit could detect the Aβ42 peptide in CSF and plasma at sub-pg/mL concentrations.  This study demonstrates the value of evaluating both novel and established biomarkers of neurodegeneration across distinct sample types.
  • Tracking technology trends to maximise commercialisation value
    Tracking technology trends to maximise commercialisation value Mireya McKee CEO of McKee Innovation Consulting Sep 26 2018 3:00 pm UTC 60 mins
    Technology commercialisation at its core requires for an invention to be applied to a use case in a specific market. Doing this successfully will ensure that you are getting ROI out of your research and inventions. Mireya McKee has over 16 years experience in research, academia and commercialisation and will be talking about how she utilises technology trends to maximise commercialisation value.

    Some of the topics discussed in this webinar will be:

    * How to track technology trends
    * What can patents tell us about technology trends
    * Technology adoption cycle
    * How technology readiness levels can affect commercialisation opportunities
  • Multiplex immunoassay detection of Alzheimer’s disease biomarkers: Session 2
    Multiplex immunoassay detection of Alzheimer’s disease biomarkers: Session 2 Anthony Saporita, PhD Sep 26 2018 3:00 pm UTC 75 mins
    Monitoring protein biomarkers in cerebrospinal fluid (CSF) of patients with Alzheimer’s Disease (AD) has been highly beneficial to understanding disease progression. While several CSF biomarkers can reproducibly distinguish normal and diseased samples, CSF is a difficult biological fluid to obtain in research studies. The need for blood-based biomarkers of AD has driven a continuous search for novel candidates. Here we report the development of a multiplex immunoassay to quantitatively measure seven proteins present in both CSF and blood that are involved in neurological disease: Neurogranin, TREM2, ApoE4, FABP3, Ferritin, angiogenin, and prion protein. Notably, presence of the APOE4 allele is prominently associated with an increased risk for AD, in comparison to the APOE2 and APOE3 alleles. Although these ApoE isoforms differ at only one or two amino acids, our assay distinguished ApoE4 with minimal cross-reactivity. Using this novel immunoassay, we measured these 7 biomarkers in CSF, plasma, and serum from AD patients and healthy controls. Additionally, we developed an ultrasensitive Single Molecule Counting (SMCTM) assay for amyloid beta 1-42 (Aβ42). This kit could detect the Aβ42 peptide in CSF and plasma at sub-pg/mL concentrations. This study demonstrates the value of evaluating both novel and established biomarkers of neurodegeneration across distinct sample types.
  • Overview of Certification Procedures for Organic Certified Reference Materials
    Overview of Certification Procedures for Organic Certified Reference Materials Ingrid Hayenga, PhD & Markus Obkircher, PhD Sep 27 2018 6:00 am UTC 75 mins
    his webinar highlights the different certification procedures regarding organic standards.

    Certified reference materials (CRMs) are an important and essential part of quality assurance. Laboratories accredited according to ISO 17025 must use CRMs on a regular base to prove their quality.

    For organic compounds, only a very limited number of CRMs from metrological institutes are available, due to this the big challenge is traceability.


    In this webinar, you will learn:
    •The certification process of the organic standard solutions by qNMR from the point of view of a commercial producer of certified reference materials under ISO/IEC 17025 and ISO 17034 accreditation.
  • Overview of Certification Procedures for Organic Certified Reference Materials
    Overview of Certification Procedures for Organic Certified Reference Materials Ingrid Hayenga, PhD & Markus Obkircher, PhD Sep 27 2018 2:00 pm UTC 75 mins
    This webinar highlights the different certification procedures regarding organic standards.

    Certified reference materials (CRMs) are an important and essential part of quality assurance. Laboratories accredited according to ISO 17025 must use CRMs on a regular base to prove their quality.

    For organic compounds, only a very limited number of CRMs from metrological institutes are available, due to this the big challenge is traceability.


    In this webinar, you will learn:
    •The certification process of the organic standard solutions by qNMR from the point of view of a commercial producer of certified reference materials under ISO/IEC 17025 and ISO 17034 accreditation.
  • Extractables and leachables testing using a Quality Risk Management approach
    Extractables and leachables testing using a Quality Risk Management approach Dhaval Tapiawala, Pfizer Oct 17 2018 2:00 pm UTC 75 mins
    • Understanding extractables and leachables for better adoption of single use systems
    • Ensuring safety of drug through determining the level of leachables throughout product life cycle
    • Case Study of implementation of standardized testing protocol
  • Application of Multivariate Data Analysis for Process Diagnostic and Root Cause
    Application of Multivariate Data Analysis for Process Diagnostic and Root Cause Ramila Peiris, Ph.D., Manager, Process Modelling and Process Analytical Technology, Sanofi Pasteur Oct 23 2018 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.
  • Advances and Challenges in Vaccine Development and Manufacture
    Advances and Challenges in Vaccine Development and Manufacture Tony D’Amore, Sanofi Pasteur Nov 2 2018 2:00 pm UTC 75 mins
    This webinar reviews the constraints and complexities of vaccine product development and manufacture.
    The evolution of bioprocess and analytics innovation and technologies to overcome these challenges are discussed.
    The strategy and leveraging of innovation and technology for rapid product development and accelerating timelines is described.
    Case studies to illustrate the advances in vaccine development and manufacture are illustrated.
    A look into the future with state of the art technologies.