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Life Sciences

  • 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.
  • Scientific Data Explosion: Adapting IT Infrastructure So Research Can Thrive
    Scientific Data Explosion: Adapting IT Infrastructure So Research Can Thrive Adam Kraut, BioTeam - Scott Jeschonek, Avere Systems - Tim Carroll, Microsoft Azure Recorded: Jun 6 2018 57 mins
    The advancements in scientific computing and healthcare are coming fast—from next generation sequencing onto precision medicine, “big data” and artificial intelligence. We’re embarking on a massive convergence of clinical analysis and information systems, and many are not prepared. With these advancements in technologies, comes higher demand for both compute and storage to degrees difficult to comprehend. An NCBI published study predicts that up to 40 exabytes of storage capacity will be needed by 2025 just to support the growth of sequenced human genomes.
    Adapting to this exciting shift in science will require changes in the way we think about IT infrastructure. In this webinar, BioTeam’s Adam Kraut will discuss…

    •How science changes faster than IT infrastructure, and what we can do to keep pace.
    •Converged infrastructures and their impact on research productivity.
    •How machine learning and microservices are changing the way we architect Cloud solutions.

    In addition, you’ll hear how companies are already supporting HPC workloads in hybrid cloud environments to increase analytic throughput efficiently. These workloads supply adaptability to changing research needs, integration into existing resources, and scalability to support growing demand for both compute and storage capacity.
  • FINDING THE COMMON ROAD TO QUALITY FOR SINGLE-USE MATERIALS
    FINDING THE COMMON ROAD TO QUALITY FOR SINGLE-USE MATERIALS Dr Trishna Ray-Chaudhuri, Genentech & Dr Hélène Pora of Pall Biotech | Recorded: Jun 6 2018 65 mins
    – GMP requirements touch every single use assembly used in clinical studies to commercial manufacturing. The drug product produced in clinical studies are given to patients.

    – GMP practices followed in producing the single use assemblies will ensure that there is no risk to patients in clinical trials and future commercial products.

    IF WE CAN”T PROVE GMP WHAT HAPPENS?

    -Single use assemblies will not be accepted by regulatory agencies and internal quality departments as an alternative to stainless steel tanks.

    -The perception will continue that there is inadequate quality controls on single use assemblies as GMP practices are not adequately followed.

    – Implementation of single will be inhibited

    Presented by Dr Trishna Ray-Chaudhuri, Senior QC Scientist in Direct Materials in Global Analytical Sciences & Technology / Global QC, Genentech

    DRiIVING QUALITY & RESPONSIVENESS IN SINGLE-USE TECHNOLOGIES

    Single-use technologies require a shift of responsibility from biomanufacturers to suppliers to enable production of safe and reliable drugs. One of the pre-requisites for efficient supply is to have standardized processes to design and manufacture single-use systems.
    Pall has developed a unique design, quality and business tool to drive quality and responsiveness, and to support standardization of single-use technologies. We will take you through the functionalities of this system and demonstrate what benefits it brings to end users when implementing single-use technologies in a regulated environment.

    Presented by Dr Hélène Pora, Vice President Technical Communication & Regulatory Strategy , Pall Biotech
  • 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: Thin Coating Method Best Practices
    Short Tutorial: Corning® Matrigel® Matrix: Thin Coating Method Best Practices Corning Life Sciences Recorded: Jun 4 2018 3 mins
    Looking for tips using Matrigel matrix before you coat and plate your cells? We’ve got you covered. Watch our short tutorial for best practices on how to coat Matrigel Matrix as a thin gel layer.
    In search of more Matrigel matrix user information? We’ve summarized some other great tips and tricks for Matrigel in our newly published "Ultimate Guide to Matrigel Matrix" – download it today: https://goo.gl/9Nq5Td
  • Short Tutorial: Corning® Matrigel® Matrix: Thin, Non-gelled Protein Layer Method
    Short Tutorial: Corning® Matrigel® Matrix: Thin, Non-gelled Protein Layer Method Corning Life Sciences Recorded: Jun 4 2018 3 mins
    Trying to use Matrigel matrix for cell attachment? Watch our short video to learn the best way to coat Matrigel matrix in a thin, non-gelled protein layer.
    Interested in some more Matrigel matrix best practices? We’ve summarized some other great tips and tricks for Matrigel in our newly published "Ultimate Guide to Matrigel Matrix" – download it today: https://goo.gl/9Nq5Td
  • 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
  • Short Tutorial: Corning® Matrigel® Matrix: Thawing Best Practices
    Short Tutorial: Corning® Matrigel® Matrix: Thawing Best Practices Corning Life Sciences Recorded: Jun 1 2018 3 mins
    We get a lot of questions on the best ways to thaw Matrigel matrix. Are the color changes normal? What are the best ways to ensure homogeneity? Get the answers to these questions and other best practices for effectively thawing the most widely used ECM in research, Corning Matrigel Matrix. We’ve summarized some other great tips and tricks for Matrigel 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
  • 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.
  • 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 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 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.
  • 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 and 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.
  • 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.