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Medical Research

  • 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.
  • An Interview with Dr Günter Jagschies, of GE BioProcess teams
    An Interview with Dr Günter Jagschies, of GE BioProcess teams Interview with Dr. Günter Jagschies, business advisor for the GE BioProcess teams Recorded: Jun 18 2018 65 mins
    AN INTERVIEW WITH DR GÜNTER JAGSCHIES, OF GE BIOPROCESS TEAMS ON WHAT ARE THE MAIN OPPORTUNITIES AND CHALLENGES IN THE RAPIDLY EVOLVING ASIAN BIOPHARMA MARKETS?

    Demand for better, more precise, and effective medicines is driven by a changing global population and increased economic power in growth economies. Asia and the Sub-Saharan Africa are almost exclusively driving the global population growth. Also, the ageing populations are growing there, resulting in an increased demand on the healthcare systems. But simultaneously, there are also more and more Asian patients who can afford treatment with biologics, which is aided by generally lower price levels and improved economic situations in the region.

    Currently, the Asian biopharma industry is mainly concentrated in China, India, South Korea, Japan, and Taiwan, but the development of these markets is going to be heterogenous as they have, for example, different starting points, local policies and biopharma know-how. However, these countries are likely to face a market fragmentation challenge, because a large number of Asian companies are all focusing on the development of biosimilars for only a very few (5-10) original drugs, while at the same time many multinational companies are also entering the region. This requires more product development and manufacturing innovation from the local players to develop a differentiated position in their markets and to move to original drugs, although access to affordable biosimilars is also critical.
  • 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
  • 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.
  • Current State and Future Prospects for Primary Human  Hepatocytes in Basic Resea
    Current State and Future Prospects for Primary Human Hepatocytes in Basic Resea Edward L. LeCluyse, Ph.D. Recorded: Jun 5 2018 62 mins
    This presentation will focus on the current trends in hepatic culture technologies and considerations for how they are impacted by the quality and performance of the cell materials used. The current state-of-the-art in procurement, production and characterization of primary hepatocytes for in vitro research applications will be reviewed, and measures for improving the validation and qualification of hepatic cells for specific applications also will be proposed.
  • Extractable Study Design & Data Evaluation of Polymeric Product Contact Material
    Extractable Study Design & Data Evaluation of Polymeric Product Contact Material Dr. Ping Wang, Principal Scientist, Janssen R&D & Dr Nixdorf, SGS Group Recorded: Jun 5 2018 74 mins
    Concerns over the safety and drug product qualities due to extractables and leachables (E&L) from polymeric Product Contact Materials (PCM), especially single use systems, in the manufacturing, packaging and delivery of biologics have increased in recent years. Based on surveys and author’s experience, almost all major regulatory agencies require the E&L risk assessment of PCM for new biologics license applications (BLA). To ensure the E&L data are suitable for the assessment of intended application of the PCM, the health authorities are paying close attention to the study design, analytical assays employed, and how the extractable data being used to conduct a safety risk assessment of the materials. The key to the success is to ensure the study design and data interpretation is product and process specific. The lack of relevant E&L data from suppliers presents end-users a great challenge. Strategies of developing relevant extractable data and applying that in the toxicological evaluation will be discussed.
  • Short Tutorial: Corning® Matrigel® Matrix: Thick Coat Method Best Practices
    Short Tutorial: Corning® Matrigel® Matrix: Thick Coat Method Best Practices Corning Life Sciences Recorded: Jun 4 2018 3 mins
    Did you know that cells can be cultured inside Matrigel matrix? Learn more about the “thick-coating” method to embed cells in a 3D, more in vivo-like environment.
    Looking for more great Matrigel Matrix tips and tricks? We’ve summarized a bunch in our newly published "Ultimate Guide to Matrigel Matrix" – download it today: https://goo.gl/9Nq5Td
  • Duolink PLA Technology: How to detect and quantify protein interactions
    Duolink PLA Technology: How to detect and quantify protein interactions Cláudia Emanuele, Ph.D. and Holly Johnson Recorded: Jun 1 2018 52 mins
    Duolink® proximity ligation assay (PLA) technology allows you to visualize protein interactions with cellular localization and quantities by amplifying signals corresponding to single and post-translational protein events. With 1000x sensitivity and high specificity, this protein detection technology allows to visualize protein functions, all within a native cell. The PLA method provides:
    - Visual protein interactions – both stable and transient
    - Endogenous protein detection – no overexpression or genetic manipulation
    - High specificity – use of two antibodies/probes eliminates false positives
    - Single molecule sensitivity – rolling circle amplification makes proteins visible
    - No special equipment needed – standard immunofluorescence methods

    This webinar will review how to Work with PLA technology and provide an overview of their potential along with example applications.

    Topics covered:
    - How to work with Duolink PLA technology
    - Overview of most relevant applications using Duolink
    - Product offering to run an assay with PLA using Immunofluorescence or Flow Cytometry
  • The Rise of Digital Enterprise: Growth Strategies for Healthcare Companies
    The Rise of Digital Enterprise: Growth Strategies for Healthcare Companies Nitin Naik, Slava Akmaev Chief Analytics Officer, BERG, Guillaume Kerboul, Dassault Systemes; Dr. Thorsten Harzer, QIAGEN Recorded: May 31 2018 59 mins
    Digital Transformation is powering growth opportunities in Smart R&D, Patient Engagement, and Healthcare eCommerce. The explosion of patient centricity and technological advancement in big data analytics, cloud and artificial intelligence are putting severe pressures on companies to leverage all types of data (clinical, social media, IOT, etc.) in innovative ways. While the industry is decidedly upbeat on this new trajectory, there are heightened concerns about managing data privacy, especially for data flows outside the traditional ecosystem.

    Key Takeaways:
    • Learn about trends and growth opportunities in the Life sciences IT sector
    • Discuss hot topics, including Smart R&D, Digital Manufacturing, Connected patient and IVD eCommerce (B2C models)
    • Hear from industry leaders about company growth strategies and best practices for implementing digital solutions
    • Gain perspectives on M&A’s and the impact of investments from Big Tech companies
  • Learn From The Editors - Tips For Impactful Submissions
    Learn From The Editors - Tips For Impactful Submissions Dr. Ella Hinson and Dr. Rebecca Cooney Recorded: May 31 2018 68 mins
    Join Dr. Ella Hinson, Senior Editor with Cell Host & Microbe, and Dr. Rebecca Cooney, North American Executive Editor of The Lancet, to learn about techniques and strategies for authoring in high-impact journals. Dr. Hinson will present information on authoring with Cell Press, which includes such titles as Cell, Neuron, Chem, Immunity, Joule, and Cancer Cell. Dr. Cooney will represent publishing in the Lancet family of journals.

    The editors will present their experience working with researchers and authors throughout the research publishing cycle, how to develop papers for premium publications, and the opportunity to broadly disseminate findings.
  • Beyond the Cel-1 Assay:  Advancements in the Gene Editing Workflow
    Beyond the Cel-1 Assay: Advancements in the Gene Editing Workflow Mark A. Gerber, Jr., Ph.D. Recorded: May 30 2018 58 mins
    Gene editing has become a firmly established technology within the discovery sciences arena. With the advent of CRISPR/Cas9 systems, the researcher's ability to find an active nuclease for nearly any region of any genome is now a reality. Even with better nucleases available, those who routinely use gene editing tools to manipulate cell lines encounter other significant challenges that pose a barrier to building the "correct" cell line model. As a well-established partner for custom cell line engineering, we at MilliporeSigma have encountered many of these challenges and have developed and/or implemented a number of methods to circumvent them. Several of these methods and the new tools available for gene editing will be discussed in this webinar, along with a summary of how they have impacted our internal cell line engineering programs.
  • Current USP Perspectives on a Rapid Sterility Test
    Current USP Perspectives on a Rapid Sterility Test Dr David Roesti, Novartis/USP and Erin Patton, Charles River Recorded: May 30 2018 65 mins
    The current growth-based Sterility Tests with at least 14-days incubation is not suitable for short-lived products. An expert panel was formed under the USP General Chapters– Microbiology Expert Committee to provide recommendations on user requirements specifications and candidate technologies based on the URS in the area of rapid sterility tests. Based on the evaluation of the URS, the expert panel made recommendations for appropriate modern/rapid technologies available from multiple vendors. The next step would be to recruit collaborating labs to conduct the proof-of-concept studies that would support drafting of a rapid sterility test chapter in the USP.
  • 最新技術  Corning®可溶性マイクロキャリアの培養システムを初公開
    最新技術 Corning®可溶性マイクロキャリアの培養システムを初公開 コーニングインターナショナル株式会社 ライフサイエンス事業部 石渡孝至 Recorded: May 29 2018 30 mins
    シングルユース技術導入ポイントとなる効果的な細胞培養と分離工程の簡素化を実現するアプリケーションをMSC(間葉系幹細胞)を例に概説します。
  • Custom Assay Development & Services utilizing Single Molecule Counting (SMC™)2
    Custom Assay Development & Services utilizing Single Molecule Counting (SMC™)2 Sarah Hamren, Head of Custom Assays & Sample Testing, Merck KGaA, Darmstadt, Germany Recorded: May 24 2018 36 mins
    Single molecule counting (SMC™) technology enables precise measurement of molecules at levels previously undetectable, down to the femtogram/mL levels, allowing researchers to identify new biomarkers, or assist in therapeutic development with an improved view of efficacy, safety & time course studies. When time and resources are limited, Merck KGaA offers a comprehensive portfolio of Custom Services supported by a scientific team with core expertise in SMC™ technology. Learn how our team will partner with you to develop a project specific to your requirements, whether that is fit-for-purpose sample testing, biomarker analysis using our current SMC™ immunoassays, or development and manufacture of an immunoassay for your novel target of interest. Learn how we work with our clients to define and tailor a customized project plan that includes milestone driven tasks, collaborative data review and progress reports. Whether your focus is to expedite your clinical research or to transfer a method to a CRO, we will show you how our services can help you accelerate programs from discovery into clinical trials.
  • Chemical patents: What can they tell us about failing drug discovery?
    Chemical patents: What can they tell us about failing drug discovery? Roshan Jumnah, Chemical IP Data Analyst at PatSnap Recorded: May 23 2018 49 mins
    Modern drug discovery appears in many ways to be well-defined with tried-and-tested approaches to acquire success. However, some research processes often lead to very few new discoveries and sometimes stagnation of an entire research area.

    So, does it always have to be this way? One method to re-boot a failing area of research is to employ disruptive chemical methods and thinking to kick-start a process of rejuvenation.

    We invite you to our webinar with Roshan Jumnah, Chemical IP data analyst at PatSnap to explore:

    - Can we identify the reasons why drug discovery is failing?
    - Chemical disruption, its uses, and the impact of this new approach on the pharmaceutical industry
    - The ways chemical disruption can reverse failing drug discovery in the future.
  • Systematic searching with Emtree
    Systematic searching with Emtree Embase Customer Care Representative: Dr. Josephine Zimmermann Recorded: May 23 2018 52 mins
    Embase wouldn’t be Embase without Emtree, the life science thesaurus is a hierarchically structured, controlled vocabulary, for Biomedicine and related Life Sciences, providing a consistent description for Embase indexing.

    - It offers indexers a comprehensive vocabulary to describe the content of biomedical data;
    - For database users, it facilitates comprehensive searching and high precision retrieval.

    Emtree has been used to index Embase (including Embase Classic) since 1947, and is unrivalled in its coverage of drug and medical terminology.

    In this webinar, Embase Customer Care Representative Dr. Josephine Zimmermann will walk you through:

    - How Emtree is built-up and managed
    - How we index a typical article
    - How drugs, diseases and devices are indexed in Embase

    About the speaker:
    Josephine Zimmermann holds a PhD in Molecular and Structural Chemistry and Physics from University of Grenoble for her research on the synthesis of fluorescent core-shell nanoparticles for medical imaging. Since two years, she works as Customer Care Representative at Elsevier and supports Embase as well as other Life Science Products. She is reporting the voice of the customer by collaborating closely with the Embase team, analyzing tendencies, providing feedback, and helping you with any kind of issues.
  • Custom Assay Development and Services utilizing Single Molecule Counting (SMC™)
    Custom Assay Development and Services utilizing Single Molecule Counting (SMC™) Sarah Hamren, Head of Custom Assays & Sample Testing, Merck KGaA, Darmstadt, Germany Recorded: May 23 2018 32 mins
    Single molecule counting (SMC™) technology enables precise measurement of molecules at levels previously undetectable, down to the femtogram/mL levels, allowing researchers to identify new biomarkers, or assist in therapeutic development with an improved view of efficacy, safety & time course studies. When time and resources are limited, Merck KGaA offers a comprehensive portfolio of Custom Services supported by a scientific team with core expertise in SMC™ technology. Learn how our team will partner with you to develop a project specific to your requirements, whether that is fit-for-purpose sample testing, biomarker analysis using our current SMC™ immunoassays, or development and manufacture of an immunoassay for your novel target of interest. Learn how we work with our clients to define and tailor a customized project plan that includes milestone driven tasks, collaborative data review and progress reports. Whether your focus is to expedite your clinical research or to transfer a method to a CRO, we will show you how our services can help you accelerate programs from discovery into clinical trials.
  • Precision genome editing in macrophage and CD8+ human primary T cells for immuno
    Precision genome editing in macrophage and CD8+ human primary T cells for immuno Laura Daley, PhD Recorded: May 22 2018 54 mins
    Innate immune cells play a critical role in cell-mediated immunity and have the potential to serve as cell-based therapies to treat a broad spectrum of immune diseases such as cancer and autoimmune disorders. Modified immune cells, such as genetically engineered CAR-T cells, have proven to be critical in developing new cell-based therapies for these diseases. However, immune cell biology creates challenges during the gene-editing process that lead to hyper-regulated RNA and DNA sensing pathways and enhanced cell death upon introduction of exogenous ribonucleotides. Further, engineering in primary immune cells is often restricted due to their limited expansion capacity. Genetic engineering in immune cells has traditionally relied on random integration of gene-editing components using viral delivery systems. In contrast, genome editing mediated by nucleases, such as CRISPR/Cas9-single guide RNPs, provide a platform for precision editing, and alleviate the potential side effects caused by randomly integrated viral DNA. While RNP gene editing in immune cells is just beginning to be considered by the immune-therapeutics field, our recent advances demonstrate that this approach can be used to create targeted modifications in two key cell types, the macrophage and the CD8+ primary T-cell. In an effort to circumvent challenges with the finite lifespan of primary T-cells, we targeted genes to edit that rendered this cell type “pseudo-immortalized”, allowing additional passages for further downstream genome editing and propagation. In addition, we demonstrated that precision editing can be used to introduce disease relevant SNPs into the macrophage genome, which resist introduction of exogenous ribonucleotides due to the induction of apoptotic pathways. Advances such as these overcome many of the obstacles currently faced with immune cell editing and offer improved gene stability and expression in immune cells and will transform the Immuno-Oncology and Gene Therapy fields.
  • Platform tech development for biosimilar upscaling
    Platform tech development for biosimilar upscaling Dr Hung Fai Poon, President, QuaCell Biotech Ltd Jun 21 2018 8:00 am UTC 75 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
  • IoT & A.I. For Good
    IoT & A.I. For Good Wael Elrifai, Vice President of Solution Engineering, Big Data, IoT & A.I, Hitachi Vantara Jun 21 2018 6:00 pm UTC 60 mins
    Wael Elrifai shares his experience working in the IoT and AI space; covering complexities, pitfalls, and opportunities to explain why innovation isn’t just good for business—it’s a societal imperative.
  • Digital Therapeutics: Trends and Growth Opportunities
    Digital Therapeutics: Trends and Growth Opportunities Frost & Sullivan's Global Digital Health Team, Wolf Shlagman CEO - Care Angel, Amer Haider CEO - Doctella Jun 26 2018 6:00 pm UTC 75 mins
    Digital therapeutics presents a significant opportunity for traditional pharmaceutical therapeutics and information technology (IT) capabilities to influence a new approach to increase positive patient outcomes while reducing the overall cost of healthcare.

    Key Takeaways:
    · Gain expert insight into the accurate definition of digital therapeutics and market participants.
    · Learn about new solutions from mHealth companies that will combine apps, patient education, professional intervention and peer support to increase patient engagement and medication adherence by augmenting or replacing traditional drug therapeutics.
    · Hear opportunities to utilize digital therapeutics to improve medical workflow and patient communications.
    · Learn about some of the critical milestones related to digital therapeutics.
  • Modelling Piezoelectric Devices
    Modelling Piezoelectric Devices Paul Wilson, Knowledge Transfer Associate, Queen's University Belfast and Richard Chippendale, Technical Manager, COMSOL Jun 27 2018 1:00 pm UTC 60 mins
    In this webinar, learn about a multiphysics approach for modelling piezoelectric devices with couplings between electrostatics, acoustics and structural mechanics. Incorporating such models within the design process enables a better understanding of the interactions between structural materials, piezoelectric ceramics and fluid damping, which can reduce development time and prototyping costs.

    Piezoelectric transducers can be used, for example, in ultrasonic cleaning, sonochemistry and cell disruption or homogenisation. For such applications it is important to accurately design the ultrasonic horns (or sonotrodes) to increase the amplitude of piezoelectric vibrations and transfer energy to liquids through the production and disintegration of microscopic bubbles.

    In this presentation, Paul Wilson from Queen's University Belfast will discuss how to design such a horn to maximise power transfer to a liquid. An existing transducer will be modelled and the tuning of material parameters to match experimental results will be discussed. Parametric sweeps are then used to investigate the design space of the horn and predict the electrical and mechanical properties of the model. These results can then inform experimental procedure, where the simulated response shows strong agreement with laboratory measurements.

    The webinar will include a live demonstration in the COMSOL Multiphysics® software and conclude with a Q&A session.
  • 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. Jun 28 2018 2:00 pm UTC 75 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.
  • MilliporeSigma CRISPR Protein Products
    MilliporeSigma CRISPR Protein Products Yanfang Jiang, Ph. D. Jun 28 2018 3:00 pm UTC 75 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.
  • Multiplexed immunofluorescence and digital image analysis for clinical use
    Multiplexed immunofluorescence and digital image analysis for clinical use Mehrnoush Khojasteh, PhD & Lei Tang, PhD Jun 28 2018 3:30 pm UTC 75 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,
  • Soft Tissue Cancer & IHC
    Soft Tissue Cancer & IHC Jeff Gordon Jun 29 2018 3:00 pm UTC 75 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.
  • Changing Landscape: How Life Sciences Companies can Respond to the Latest Brexit
    Changing Landscape: How Life Sciences Companies can Respond to the Latest Brexit Andrew McConaghie Jul 5 2018 1:00 pm UTC 60 mins
    Brexit means Life Science companies operating in the UK and Europe are having to rapidly respond to a changing but still uncertain landscape. The lack of clarity in trade and regulation for the sector means life science companies need to make multiple risk assessments and plans for a number of scenarios.
  • Object Storage: What it is, What it Solves, and How it Compares
    Object Storage: What it is, What it Solves, and How it Compares Mike McWhorter, Senior Technologist, Western Digital Jul 10 2018 4:30 pm UTC 30 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.
  • Raman spectroscopy measurements during Bioprocessing
    Raman spectroscopy measurements during Bioprocessing Nobel Vale, Research Scientist II, Bristol-Myers Squibb Jul 11 2018 2:00 pm UTC 75 mins
    Raman spectroscopy has been seen as spectroscopic tool used in bioprocessing to monitor and control cell metabolism to optimize quality and yield of titer. This is due to Raman’s insensitivity to water and ability to analyze samples without manipulation. However there are certain challenges for Raman when analyzing a complex and dynamic sample such as a cell culture. This article will describe the different challenges in analyzing in-line Raman data and how to mitigate changes in samples that include changes in fluorescence background, presence of cells/debris in samples, and spectral interference.
  • Development and Manufacturing of Recombinant Nanoparticle Vaccines
    Development and Manufacturing of Recombinant Nanoparticle Vaccines Atin Tomar, CPL Biologicals Jul 12 2018 9:30 am UTC 75 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.
  • 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 Jul 18 2018 2:00 pm UTC 75 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.
  • Introducing the CellStream® System, A Highly-Sensitive, 7-Laser Flow Cytometer
    Introducing the CellStream® System, A Highly-Sensitive, 7-Laser Flow Cytometer Robert Smith-Mccollum and Christine Probst Jul 18 2018 3:00 pm UTC 75 mins
    MilliporeSigma is excited to launch the new CellStream® 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 CellStream® 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.
  • 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®[1] to predict kidney toxicity. The OrganoPlate® is a microfluidic platform, which enables high-throughput culture of boundary tissues in miniaturized organ models. In OrganoPlates®, extracellular matrix (ECM) gels can be freely patterned in microchambers through the use of PhaseGuide technology. PhaseGuides (capillary pressure barriers) 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.
    [1] S. J. Trietsch, G. D. Israëls, J. Joore, T. Hankemeier, and P. Vulto, “Microfluidic titer plate for stratified 3D cell culture.,” Lab Chip, vol. 13, no. 18, pp. 3548–54, Sep. 2013.
  • Lifecycle management of single use technologies
    Lifecycle management of single use technologies Francis Verhoeye, Director Single Use Technologies, GSK Vaccines Jul 25 2018 12:00 pm UTC 75 mins
    Single-use technologies (SUTs) are one of the key drivers in the biopharmaceutical industry today and are changing the way we are operating and qualifying our bioprocesses, offering more flexibility and increasing efficiency. However, the extended use of those technologies in commercial operations requires a robust and specific lifecycle management approach. In this context, we have built an improved technical lifecycle management approach involving close partnership with key suppliers, enhanced standardization, early involvement of global manufacturing functions and full compliance with item creation process in order to ensure business continuity and value creation.
  • 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 & Filipe Gaspar, Hovione FarmaCiência Jul 25 2018 2:00 pm UTC 75 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.
  • 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 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.
  • 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.
  • 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, Lupin 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.
  • 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 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.