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Life Sciences

  • A breath of fresh air with Corning® HYPER Technology
    A breath of fresh air with Corning® HYPER Technology
    Julius Ang Recorded: Aug 13 2020 60 mins
    Traditional 2D stacked vessels have been widely accepted as production platforms for vaccines, cell and gene therapies. However, there are limitations in providing good gas supply to all layers without active gassing. Large scale vessels are also bulky and require additional handling and incubator space. With proper considerations, these vessels can perform adequately, however, there is a need to increase product yields and improve process and operational efficiencies to meet evolving market demands.

    To address this need, Corning offers HYPER (High Yield PERformance) technology including HYPERFlask® and HYPERStack® cell culture vessels which brings a breath of fresh air to adherent cultures in conventional stacked vessels. In addition to improving operations, HYPER vessels can generate greater yields per volumetric footprint saving time, space and labor.

    In this webinar, learn more about Corning’s HYPER gas-permeable film technology and how this unique approach optimizes production value in the fields of cell and gene therapy.

    About the presenter:
    Julius is currently the Applications and Technical Support Manager for Greater Asia. He first started his career in biologics as an Upstream Scientist with Baxter and Lonza, both in Singapore and the United Kingdom. He then moved into regional commercial roles at Thermo Fisher Scientific and Merck supporting various upstream technologies and providing technical consultation to customers in Asia.

    Julius has extensive experience in cell line development, high throughput selection, media development, bioreactor evaluations and process transfer to large scales.
  • Rapid T Cell Human Immune System ImmunoGraft® Platform to test PD of IOTherapy
    Rapid T Cell Human Immune System ImmunoGraft® Platform to test PD of IOTherapy
    Bhavna Verma, PhD, Scientist II, ImmunoOncology Department, Champions Oncology Recorded: Aug 12 2020 21 mins
    Champions Oncology was excited to participate in the American Association of Cancer Research’s (AACR) Virtual Meeting in June. Due the limited availability of access to these posters, we wanted to give you direct access to our expert researchers and all the details of the newest innovations happening at Champions. Therefore, we have set up Poster Talks with each presenter so that you can register, attend and ask questions live during each session – just like you were at AACR2020 face-to-face. The key poster takeaways you will learn by watching this webinar are:
    •Learning more about Champions Oncology’s T cell ImmunoGraft® platform and it’s applications in vivo using CDX and PDX.
    •Engraftment and infiltration of T cells in CDX and PDX models.
    •Expression of costimulatory and inhibitory markers in the platform.
  • Operational & Regulatory Factors in Cross-Border Enrollment in Rare Disorders
    Operational & Regulatory Factors in Cross-Border Enrollment in Rare Disorders
    Hanna Wide Director, Program Delivery Rare Diseases & Pediatrics at Premier Research Recorded: Aug 11 2020 19 mins
    Researchers are more focused than ever on finding treatments and cures for rare diseases, encouraged by a regulatory environment that is increasingly welcoming to innovation and collaboration. But even under these favorable conditions, the potential success of orphan drug development hinges on finding patients and getting them to trial sites.

    Patients for rare disease trials can be exceedingly hard to find, and because of variations in regulations, hospital capabilities, standard of care, and/or financial reasons, it’s often not practical to have trial sites in each of the countries where patients live. This webinar will examine challenges and solutions in cross-border trial enrollment, including:

    - Working with sponsors and investigators as well as patients, their caregivers, and local physicians to populate trials
    - Understanding the regulatory landscape for cross-border enrollment including submission requirements and informed consent as well as the requirements for visa and insurance
    - Ensuring anonymity of patient records, either by working with local healthcare providers or relying on information provided by the patient or caregiver
    - Paving the way for uneventful patient and caregiver travel by minimizing out-of-pocket costs and providing support for visa interviews, travel booking, local accommodations, and more
    - Carefully attending to the details of living in another country to maximize patient retention

    Premier Research’s rare disease experience spans more than 190 rare disease trials over the past five years. Our connections with patient advocates help us locate hard-to-find patients, even among extremely small populations. Register to get access to insights you can leverage in your rare disease drug development program.
  • Sampling Devices for In-line near Infrared Spectroscopy Monitoring of Powder...
    Sampling Devices for In-line near Infrared Spectroscopy Monitoring of Powder...
    Anders Sparén Associate Principal Scientist at AstraZeneca and Ed Gooding, MicroNIR Photonic Applications Specialist at VIAVI Recorded: Aug 11 2020 73 mins
    Sampling Devices for In-line near Infrared Spectroscopy Monitoring of Powder Blend Homogeneity in Continuous Manufacturing

    In continuous direct compression of pharmaceutical formulations, it is essential to assess the homogeneity of powder blends. This could preferably be done in situ, using fast spectroscopic techniques. In this study, near-infrared spectroscopy was used to study powder blend homogeneity at two positions in the continuous manufacturing process; after the first blender and in the tablet press feed-frame. The focus of the study was on sample presentation at the two positions, and several sampling devices were tested in a laboratory setting using a model formulation, aiming at improving the quality of the NIR measurements. The results for the sampling devices tested are compared and the future implementation in the continuous manufacturing equipment is discussed.


    Followed by Powder Blend Homogeneity Monitoring with the Viavi MicroNIR PAT-W

    The MicroNIR PAT-W wireless NIR spectrometer is used in monitoring blend uniformity in pharmaceutical manufacturing. The PAT-W is a rugged, IP65/67 rated instrument with no moving parts. The PAT-W, with >8 hours battery life, WiFi communication and onboard gravity sensor is well suited for use on tumble blenders in regulated facilities. Viavi’s Linear Variable Filter technology, optical fiber-free design and dual onboard tungsten lamps ensure excellent stability, long lifetime and minimal instrument-to-instrument variability. Viavi MicroNIR Pro software provides data acquisition and chemometric model building, and assures compliance with Title 21 CFR Part 11, USP chapter 1119 and EP chapter 2.2.40. OPC communication and control are also available for use in process environments.
  • High-Resolution Characterization of Structure, Interaction, and Miscibility
    High-Resolution Characterization of Structure, Interaction, and Miscibility
    Eric Munson, Professor and Head at Purdue University Recorded: Aug 10 2020 59 mins
    Full Title: High-Resolution Characterization of Structure, Interaction, and Miscibility of Drug Products

    The local interactions between a drug and its surrounding environment is critical in both small and large molecule formulations. For small molecules, the drug-polymer interaction is needed to ensure that the drug does not crystallize in an amorphous solid dispersion. For proteins, phase separation in lyophilized formulations will lead to reduced stability and the potential for aggregation. In this presentation, the ability to probe these local structures and interactions in both small and large molecule systems will be shown. Case studies will be presented that demonstrate how structural properties (e.g. degrees of interaction, changes in conformation) can impact functional properties such as crystallization and aggregation.

    Eric Munson of Purdue University

    Eric Munson, Ph.D., is currently Professor and Head of the Department of Industrial and Physical Pharmacy at Purdue University. He received his B.A. degree from Augustana College in Sioux Falls, South Dakota, in 1987. After studying one year in Munich, Germany, on a Fulbright Fellowship, he received his Ph.D. in 1993 from Texas A&M University, and was a postdoctoral fellow at the University of California, Berkeley in 1994. He was in the Chemistry Department at the University of Minnesota before moving in 2001 to the Pharmaceutical Chemistry Department at the University of Kansas, to the Pharmaceutical Sciences Department at the University of Kentucky in 2010, where he was the Patrick DeLuca Endowed Professor in Pharmaceutical Technology. In 2018 he moved to Purdue University to become Professor and Head of the department. His research program is focused on the characterization of pharmaceutical solids using a variety of analytical techniques, with an emphasis on solid-state NMR spectroscopy. Dr. Munson is a coinventor on three patents and has published more than 100 research, review, and book chapters.
  • Identification of Approaches to Simulated Leachable Studies
    Identification of Approaches to Simulated Leachable Studies
    Jason Creasey, Managing Director at Maven E&L and Karen Pieters, Ir. Team Leader E&L at Nelson Labs Europe Recorded: Aug 7 2020 80 mins
    Full Title: Identification of Approaches to Simulated Leachable Studies: What are They? When to do Them?

    Presented by Jason Creasey, Managing Director at Maven E&L Ltd. Followed by an Industry Perspective presentation presented by Karen Pieters, Ir. Team Leader Extractables and Leachables at Nelson Labs Europe

    The term “Simulated leachable studies” is open to interpretation. I hope to provide a definition of this term and in doing so suggest when they can and should be used. The general aim of such studies is to provide an accurate qualitative and quantitative description of the substances which might be present as leachables in a pharmaceutical drug product (DP) derived from container closure system (and sometimes its manufacturing process) when the drug product is stored up to and including its shelf-life. Simulated studies provide an alternative to analysis of leachables directly in the drug product. A simulated study aims to avoid some of the downfalls of leachable analysis such as; inaccurate analysis of leachables due to interference from drug product and/or formulation elements, availability of stored DP samples, reaching required limits of detection in the DP and time / resource constraints associated with complex method development using DP.
    Simulated leachable studies must be able to accurately simulate the expected leachables in a DP and should be carefully crafted to achieve this. The system used for extraction must have similar propensity to leach from materials under study a drug product and care must be taken not to use system which either leach too much (potentially masking other substance) or too little.
  • Best Practices on Implementing Thermal Vision Solutions
    Best Practices on Implementing Thermal Vision Solutions
    Wayne Arvidson, Director, Dell Technologies and Ken Mills, CEO, Intellisite Corporation Recorded: Aug 6 2020 30 mins
    Welcome back to Dell Technologies Innovation Webinar Series. In this conversation we will have Wayne Arvidson interviewing Ken Mills CEO of Intellisite as he shares some best practices around implementing thermal vision solutions. The next generation of safety and security solutions such as thermal imaging and computer vision are being used in different ways in today’s world, and we believe this is only the beginning.
  • Identification of unknown extractables and leachables using mass spectrometry...
    Identification of unknown extractables and leachables using mass spectrometry...
    Petra Booij, Investigator at GlaxoSmithKline & Dr Kyle D’Silva, Pharma & BioPharma Marketing Leader, Thermo Fisher Scientific Recorded: Aug 6 2020 57 mins
    Full Title: Identification of unknown extractables and leachables using mass spectrometry: Identification with confidence?

    Extractable and Leachable (E&L) studies on materials used in the manufacturing process and container closer systems of drug products and drug substances are commonly used to assess the risk for patient exposure. Most often LC-MS or GC-MS is used to detect, identify and then quantify extractables and leachables. In general, an analytical evaluation threshold or reporting threshold is set based on a calculated patient exposure. Substances above the set threshold required further investigation if patient exposure exceeds this. Substances can be identified using mass spectral libraries to enable a toxicological risk assessment which considers the risk of patient exposure. However, how confident are we when we identify a substance using spectral libraries? A match with mass spectral libraries, data from orthogonal techniques, fragmentation data and availability of a certified reference standard can increase the level of confirmation. We will discuss an approach for different levels of identification and how to increase the level of confidence of identified extractables and leachables
  • Antibody patents: maximising value in Europe and beyond
    Antibody patents: maximising value in Europe and beyond
    Tom Leonard (Kilburn & Strode), Alison Care (Kilburn & Strode), Dave Wortley (Kilburn & Strode), Tom Phillips (WIPR) Recorded: Aug 5 2020 60 mins
    Antibody Patents: Maximising value in Europe and beyond

    Join antibody experts and European Patent Attorneys Tom Leonard, Alison Care and Dave Wortley of Kilburn & Strode for a 60 minute webinar discussion on the latest developments in antibody patenting on Wednesday 5th August 2020 at 4.30pm BST (8.30am West Coast, 11.30am East Coast, 5.30pm Central European Time).

    Drawing on both private practice and in-house experience, this in-depth webinar has been specifically curated for those working in the antibody field, including private practice attorneys, in-house counsel and others involved in the development and marketing of antibodies. We will explore best practice for:

    · Drafting applications, including how to maximise potential claim scope where possible and what data to include to support your claims

    · Patent filing and IP strategies, including when and where to file

    · Prosecution of global portfolios, taking into account how different patent offices examine applications relating to antibodies

    · The preparation of freedom-to-operate and landscaping opinions to best inform the business or to prepare yourself for third-party due diligence

    This webinar will run for 1 hour.
  • 7 Steps for Boosting R&D Outcomes: Mastering Clinical Trials Data
    7 Steps for Boosting R&D Outcomes: Mastering Clinical Trials Data
    Mark Ramsey Recorded: Aug 5 2020 58 mins
    Mark Ramsey, former Chief Data and Analytics Officer at GSK, shares his insights on rationalizing clinical trials data repositories.
  • Qualification of Raw Materials and Cell Substrates for Biomanufacturing
    Qualification of Raw Materials and Cell Substrates for Biomanufacturing
    Maura Kibbey Senior Scientific Fellow, Global Biologics at USP and Martin Wisher, Global Head of Regulatory Affairs at Merck Recorded: Aug 5 2020 83 mins
    Presented by Maura C. Kibbey, Ph.D., Senior Scientific Fellow, Global Biologics U.S. Pharmacopeia
    Followed by an Industry Perspective presented by Martin Wisher, PhD, Global Head of Regulatory Affairs at Merck

    The quality of starting materials is critical for successful pharmaceutical manufacturing strategies. For biomanufacturing the challenges are further amplified due to the use of a wide variety of raw materials, cell lines, and naturally-derived materials with an increased risk for the introduction of unwanted impurities and adventitious agents. This presentation will provide an overview and updates on USP documentary standards containing best practices for qualifying incoming materials, demonstrating viral clearance, cryopreservation, cell banking, and controlling impurities derived from cell substrates for therapeutic proteins.
  • Custom immune assessment using flow cytometry to support clinical development
    Custom immune assessment using flow cytometry to support clinical development
    Greg Bannish, PhD, Subject Matter Expert - Flow Cytometry, Champions Oncology Recorded: Aug 4 2020 31 mins
    Champions Oncology was excited to participate in the American Association of Cancer Research’s (AACR) Virtual Meeting in June. Due the limited availability of access to these posters, we wanted to give you direct access to our expert researchers and all the details of the newest innovations happening at Champions. Therefore, we have set up Poster Talks with each presenter so that you can register, attend and ask questions live during each session – just like you were at AACR2020 face-to-face. The key poster takeaways you will learn by watching this webinar are:
    •Considerations for immune assessment during clinical drug development
    •Key factors in a successful flow cytometry assay
    •Validation overview for flow cytometry assays to support clinical trials
    •Case study: development and validation of a 19 color human T cell panel
  • Rapid Microbiology Applications in the COVID-19 Era
    Rapid Microbiology Applications in the COVID-19 Era
    Dr. Michael J. Miller, Ulrich Herber and Lori Daane Recorded: Aug 4 2020 110 mins
    The implementation of rapid microbiological methods (RMM) has gained significant momentum over the past few years. In particular, the ATMP segment has a desire to release cell and gene therapies using rapid sterility tests to accommodate patient needs and very short drug product shelf life. Additional rapid sterility testing needs are now being fueled by companies who are developing vaccines for COVID-19 clinical trials.

    In this webinar, Dr. Michael J. Miller will present an overview of past and future microbiological methods, the current regulatory landscape for rapid sterility testing including recent policy changes, applicable technologies and validation strategies.
  • Must Know Tips for Publishing In JACC Journals
    Must Know Tips for Publishing In JACC Journals
    Dr. David J. Moliterno, Editor-in-Chief, JACC Cardiovascular Interventions Recorded: Jul 30 2020 76 mins
    Learn techniques and strategies for getting published in JACC journals with Dr. David J. Moliterno, MD, FACC, Editor-in-Chief, JACC: Cardiovascular Interventions. Dr. Moliterno will present information on publishing in JACC Journals. Dr. Moliterno will share his expertise in working with researchers and authors throughout the research publishing cycle, how to develop papers for premium publications, and the opportunity to broadly disseminate findings. One of eight JACC Journals published by the American College of Cardiology (ACC), JACC: Cardiovascular Interventions disseminated top science in interventional cardiovascular medicine, including coronary, structural, peripheral and cerebrovascular diseases. You won’t want to miss this engaging webinar and how it can benefit your research process and impact. Learn about submitting to JACC Journals and subscribe to eTable of Content emails.

    About Dr. David J. Moliterno
    Dr. Moliterno is the Editor-in-Chief of JACC: Cardiovascular Interventions. He is the Jack M. Gill Chair and Professor of the Department of Internal Medicine at the University of Kentucky. He is also a member of the interventional cardiology faculty at the Gill Heart and Vascular Institute in Lexington, Kentucky. He has been involved with numerous investigational studies in cardiovascular medicine over the last two decades, with his primary research interest being in acute coronary syndromes. Prior to assuming position as Editor-in-Chief, Dr. Moliterno served as an associate editor for the journal. An active member of the ACC, Dr. Moliterno has been a member of the Board of Governors, Strategic Education Committee, and the Interventional Section Leadership Council.
  • Setting a Real-World Strategy in an Evolving Clinical Research Environment
    Setting a Real-World Strategy in an Evolving Clinical Research Environment
    Stacy Weil - Senior Vice President of Clinical Informatics & Nach Dave, RPh. MSc, Vice President, Development Strategy Recorded: Jul 29 2020 59 mins
    Since early this year, many standard clinical trial processes have been significantly disrupted. Patients have been prevented from attending regular physician visits. Clinical research associates who traveled regularly to study sites to review and verify processes and data were unable to do so. Supply-chain upheaval has forced schedule modifications and substitutions for products in short supply. Committees and boards accustomed to meeting in person were relegated to virtual gatherings, and clinical trial logistics had to be re-evaluated for time, cost, and quality expectations.

    We need to change the way patients participate in trials and how we collect and monitor data. Adopting processes that are more flexible and agile while maintaining data integrity and quality has emerged as a primary focus for everyone involved in conducting clinical trials.

    This webinar will focus on these process steps:

    • Quality data capture. What types of technology can be used to evolve processes that require a renewed focus on remote data capture? Where will the data come from and where will it live?
    • Data access. Who will handle the data? How it will it be transmitted and processed?
    • Information review. Once data becomes information, how will it be reviewed? What initiatives are driving collaborative, data-driven decision-making?

    There is growing consensus that researchers and regulators must adopt a holistic product development approach versus the limited approach of years past. Developers will need to build development plans that include traditional clinical trials and then some. Areas that will complement the traditional randomized clinical trial data will include use of real-world data and evidence to support future clinical trial submissions, building economic strategies in support of product development, and understanding how traditional and non-traditional data points will contribute to an overall data strategy for a product or a portfolio of products.
  • 2D Ex Vivo Patient-derived AML Platform for testing Molecular-Targeted Therapies
    2D Ex Vivo Patient-derived AML Platform for testing Molecular-Targeted Therapies
    Bandana Vishwakarma, PhD, Scientist in Hematology Oncology at Champions Oncology Recorded: Jul 28 2020 22 mins
    Champions Oncology was excited to participate in the American Association of Cancer Research’s (AACR) Virtual Meeting in June. Due the limited availability of access to these posters, we wanted to give you direct access to our expert researchers and all the details of the newest innovations happening at Champions. Therefore, we have set up Poster Talks with each presenter so that you can register, attend and ask questions live during each session – just like you were at AACR2020 face-to-face. The key poster takeaways you will learn by watching this webinar are:
    •Phenotyping, media optimization and reproducibility in AML models.
    •2D AML platform and its applications evaluating small molecule inhibitors.
    •Ex vivo and in vivo sensitivity to Ara-C.
  • Connected Innovation Intelligence Tours
    Connected Innovation Intelligence Tours
    Vik Pant Recorded: Jul 27 2020 57 mins
    Join this webinar and listen to experts discussing how AI has impacted their field and the ways in which their organizations are using AI technologies to develop IP strategies that enhance data driven approaches through closer collaboration, accurate benchmarking and competitor tracking.
  • Wearables as Medical Devices
    Wearables as Medical Devices
    Samuel Gibbon Recorded: Jul 25 2020 54 mins
    In this webinar we'll explore the overlap of the wearables market with technology uncovering the trends and showcasing a particular new entrant to the wearables market.
  • Module 3: Ventana PD-L1 (SP263) Assay NSCLC Guided Digital Case Review
    Module 3: Ventana PD-L1 (SP263) Assay NSCLC Guided Digital Case Review
    Dr. Dorothy Hayden, Pathologist at Roche Tissue Diagnostics Recorded: Jul 24 2020 71 mins
    This series of videos is provided as a resource for individuals in countries where VENTANA PD-L1 (SP263) Assay is approved for use for non-small cell lung cancer (NSCLC).

    Please refer to the respective drug labeling for clinical recommendations pertaining to PD-L1 expression.

    These videos feature Roche Tissue Diagnostics Pathologist, Dr. Dorothy Hayden, and are intended to be a refresher for pathologists and laboratories on VENTANA PD-L1 (SP263) Assay in NSCLC. Module 1 is a PD-L1 and PD-L1 (SP263) assay overview , Module 2 discusses evaluation guidance for PD-L1 (SP263) assay in NSCLC, and Module 3 is a PD-L1 (SP263) Guided Digital NSCLC Case Review.
  • Module 2: Ventana PD-L1 (SP263) Assay NSCLC Evaluation Education
    Module 2: Ventana PD-L1 (SP263) Assay NSCLC Evaluation Education
    Dr. Dorothy Hayden, Pathologist at Roche Tissue Diagnostics Recorded: Jul 24 2020 18 mins
    This series of videos is provided as a resource for individuals in countries where VENTANA PD-L1 (SP263) Assay is approved for use for non-small cell lung cancer (NSCLC).

    Please refer to the respective drug labeling for clinical recommendations pertaining to PD-L1 expression.

    These videos feature Roche Tissue Diagnostics Pathologist, Dr. Dorothy Hayden, and are intended to be a refresher for pathologists and laboratories on VENTANA PD-L1 (SP263) Assay in NSCLC. Module 1 is a PD-L1 and PD-L1 (SP263) assay overview , Module 2 discusses evaluation guidance for PD-L1 (SP263) assay in NSCLC, and Module 3 is a PD-L1 (SP263) Guided Digital NSCLC Case Review.
  • Module 1: Ventana PD-L1 (SP263) NSCLC Assay Overview
    Module 1: Ventana PD-L1 (SP263) NSCLC Assay Overview
    Dr. Dorothy Hayden, Pathologist at Roche Tissue Diagnostics Recorded: Jul 24 2020 11 mins
    This series of videos is provided as a resource for individuals in countries where VENTANA PD-L1 (SP263) Assay is approved for use for non-small cell lung cancer (NSCLC).

    Please refer to the respective drug labeling for clinical recommendations pertaining to PD-L1 expression.

    These videos feature Roche Tissue Diagnostics Pathologist, Dr. Dorothy Hayden, and are intended to be a refresher for pathologists and laboratories on VENTANA PD-L1 (SP263) Assay in NSCLC. Module 1 is a PD-L1 and PD-L1 (SP263) assay overview , Module 2 discusses evaluation guidance for PD-L1 (SP263) assay in NSCLC, and Module 3 is a PD-L1 (SP263) Guided Digital NSCLC Case Review.
  • The Pathologist in the Era of Immunotherapy
    The Pathologist in the Era of Immunotherapy
    Dr. Ken Bloom Recorded: Jul 23 2020 61 mins
    The job of the pathologist is crucial in the era of precision medicine and immunotherapy. Pathologists need not only to correctly diagnose and classify tumors, but also aid in the selection of the best treatment strategies based on the presence or absence of critical biomarkers. Because tumors are heterogeneous, this includes discussion with the interventionalist about which lesions to sample in metastatic disease and selection of the best area of tumor for analysis in resections. While next generation sequencing techniques provide a plethora of data about mutations, gene expression and copy number, the pathologist must interpret these results in the context of the histologic appearance of the sample. In this webinar, Dr. Bloom will review the challenges faced by pathologists today with the emergence of immunotherapy and explain the critical role of the pathologist in assessing the tumor and its microenvironment.
  • Calidad y Acreditación en Laboratorios Un Abordaje de la Influencia de Vidrios
    Calidad y Acreditación en Laboratorios Un Abordaje de la Influencia de Vidrios
    Jerónimo Figueiredo Recorded: Jul 22 2020 58 mins
    Calidad y Acreditación en Laboratorios - Un Abordaje de la Influencia de la Vidriería para Laboratorios
    Jerónimo Figueiredo - Business Operations Manager
  • Novel Applications for Ex Vivo PDX Models of the Tumor Microenvironment
    Novel Applications for Ex Vivo PDX Models of the Tumor Microenvironment
    Chris Koehler, PhD, Director of Scientific Operations at PhenoVista Biosciences Recorded: Jul 22 2020 57 mins
    Ex Vivo platforms not only can be used to gather additional in vivo model data throughout the in-life portion of an oncology study as well as at study completion, they also can address mechanisms of action for immuno-oncology agents and test for cytotoxicity of oncology therapeutics in an ex vivo system. In this webinar, case studies will be presented to demonstrate physiologically relevant 2D and 3D ex vivo PDX Models.

    Register for this webinar to learn:
    •How to combine physiologically relevant 2D and 3D ex vivo PDX models with quantitative fluorescence imaging and luminescence assays.
    •Why Use Tumor Fragments vs. Other 3D Systems?
    •How ex vivo PDX models more accurately reflect tumor heterogeneity and in vivo microenvironment using a tumor fragment approach.
    •How incorporating a diversity of readouts, including industry standard CellTiter Glo + fluorescence microscopy, can provide additional insights to drive research programs forward.
    •How adapting design flexibility, including drug combinations, treatment length, assay timing (3 days to 21-day assays) and readouts (RNA/Protein isolation) can improve data richness.
  • がんオルガノイドを用いた抗がん剤の評価
    がんオルガノイドを用いた抗がん剤の評価
    公立大学法人 福島県立医科大学 ふくしま国際医療科学センター  医療-産業トランスレーショナルリサーチセンター セルファクトリー部門 教授 高木 基樹 先生 Recorded: Jul 22 2020 77 mins
    がん組織より樹立した長期培養が可能な「がんオルガノイド(F-PDO®)」と「がん細胞株」とのゲノム、遺伝子発現、形態等の違い、がんオルガノイドの培養やアッセイ系構築の難しさ、がん細胞株(平面培養)との抗がん剤の感受性の違いなどについて紹介致します。

    <セミナーのポイント>
    ① がんオルガノイドの樹立と培養
    ② がんオルガノイドの特徴
    ③ がんオルガノイドを用いたアッセイ系構築のポイント
    ④ がんオルガノイドとがん細胞株の抗がん剤感受性の相違
  • Webinar Replay: Organoids and Spheroids Help Science See in 3D
    Webinar Replay: Organoids and Spheroids Help Science See in 3D
    Simone Sidoli, Ph.D., Asst. Professor, Albert Einstein College of Medicine & Hervé Tiriac, Ph.D., Moores Cancer Center Aug 13 2020 3:00 pm UTC 72 mins
    3D cell culture is an indispensable tool for drug discovery research, with the ability to produce in vivo-like iterations from in vitro cultures to understand cellular mechanisms, as well as in efficacious therapeutic development.

    In this previously recorded GEN webinar sponsored by Corning, we hear from two investigators who are employing organoids and spheroids in their respective research endeavors. Dr. Hervé Tiriac tells us how his laboratory is tackling some precision medicine goals by studying patient-derived organoids for pancreatic cancer. Tangentially, Dr. Simone Sidoli describes how his research team is utilizing spheroids to gain insight into chromatin dynamics.
  • HIV-related haematological malignancies
    HIV-related haematological malignancies
    The Lancet Haematology and The Lancet HIV Aug 13 2020 3:00 pm UTC 60 mins
    Since the earliest days of the HIV epidemic, haematological malignancies have been a defining feature of illness caused by the virus; individuals with HIV are living longer and contending with the challenges of treating cancer while on ART, now, work on haematological cancers is providing insights into how a cure for HIV might be achieved. Join Peter Hayward, Editor-in-Chief of The Lancet HIV, and the Series authors as they introduce and explore the findings from this new joint Series on HIV-related haematological malignancies from The Lancet Haematology and The Lancet HIV.

    About the Speakers:
    - Satish Gopal, National Cancer Institute Center for Global Health, Rockville, MD, USA
    - Ariela Noy, Memorial Sloan Kettering Cancer and Weill Medical College, New York, NY, USA
    - Thomas S. Uldrick, Fred Hutchinson Cancer Research Center, Seattle, WA, USA
    - Peter Hayward, The Lancet HIV, London, UK
  • Monitoring Impurities in Biologics
    Monitoring Impurities in Biologics
    Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia Aug 18 2020 4:30 am UTC 59 mins
    The complexity of biotherapeutic products and their manufacturing processes can yield a variety of impurities, which must be monitored and controlled to minimize safety concerns and ensure product quality. These impurities can be broadly grouped into two categories: 1) product-related impurities, such as precursors, aggregates and degradation products, and 2) process-related impurities, such as host cell DNA, host cell protein, and particulates. This presentation will provide an overview of approaches for monitoring impurities, including a discussion of existing USP standards and standards under development to support impurity testing.

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

    Dr. McCarthy is a Senior Manager, Science and Standards within USP’s Global Biologics Department. Diane works with stakeholders to identify areas where standards are needed and define and develop new standards. Prior to joining USP, Dr. McCarthy was Senior Scientific Director at Caprion Biosciences, where she focused on the use of mass spectrometry for characterization of biologics and host cell proteins. Her previous roles also included Director of Scientific Affairs at Ezose Sciences, where she focused on identification and quantitation of glycans by mass spectrometry and Global Manager, Biomarker Research Center, at Bio-Rad Laboratories, where she directed translational and biomarker research contracts and collaborations with industry, key consortia, academic, and government groups.
  • Establishment of a Patient-derived B-ALL Ex Vivo Platform
    Establishment of a Patient-derived B-ALL Ex Vivo Platform
    Bandana Vishwakarma, PhD, Scientist in Hematology Oncology at Champions Oncology Aug 18 2020 2:00 pm UTC 30 mins
    Champions Oncology was excited to participate in the American Association of Cancer Research’s (AACR) Virtual Meeting in June. Due the limited availability of access to these posters, we wanted to give you direct access to our expert researchers and all the details of the newest innovations happening at Champions. Therefore, we have set up Poster Talks with each presenter so that you can register, attend and ask questions live during each session – just like you were at AACR2020 face-to-face. The key poster takeaways you will learn by watching this webinar are:
    •Phenotyping, media optimization and reproducibility in B-ALL Models.
    •2D B-ALL platform and its applications with therapeutic agents.
    •Coculturing of B-ALL cells with BM-MSC and its impact.
  • Biopharmaceutical process development – Trends/ Challenges/Opportunities
    Biopharmaceutical process development – Trends/ Challenges/Opportunities
    Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd and Sudhakar Nagaraj, Principal Scientist, SLS at Pall Biotech Aug 19 2020 4:30 am UTC 63 mins
    Presented by Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd

    Current trends and regulation affecting Biopharmaceutical Industry
    Journey from Lab scale to Commercial –Overcoming Scalability design hurdles
    QbD-Bringing Improvements in Biologics development and Manufacturing Space

    Followed by Quality by Design (QbD) Approach for a Virus Filtration Application
    Presented by Sudhakar Nagaraj, Principal Scientist, SLS – Global Regulatory and Validation Consulting group at Pall Biotech

    Removal of viruses in bioprocessing applications is a fundamental regulatory requirement, and the use of virus filtration is considered a robust and well accepted component of a virus clearance strategy. With the advent of the International Conference of Harmonization (ICH) Q8 Pharmaceutical Development and Q9 Quality Risk Management guidelines, there is much greater emphasis for filter users to define the filter design space, in addition to performing the mandatory virus filtration validation studies.
    A thorough understanding of the virus filtration design space not only alleviates the risk of viral contamination, but an in-depth understanding of the boundaries of the process parameters ensures the manufacturing process remains in control. In this webinar, we describe an approach to implement QbD principles into virus filtration to create a safe and robust biomanufacturing process.
  • Seguridad y Calidad en Laboratorios - Impacto en la cristalería
    Seguridad y Calidad en Laboratorios - Impacto en la cristalería
    Jerónimo Figueiredo - Business Operations Manager Aug 19 2020 7:00 pm UTC 90 mins
    Seguridad y Calidad en Laboratorios - Impacto en la cristalería
    Jerónimo Figueiredo - Business Operations Manager
  • Biopharmaceutical Process Model Evolution – Enabling Process Knowledge Continuum
    Biopharmaceutical Process Model Evolution – Enabling Process Knowledge Continuum
    Saly Romero-Torres, PhD, of Biogen and David Lovett & John Mack of Perceptive Engineering Aug 20 2020 4:30 am UTC 66 mins
    Full Title: Biopharmaceutical Process Model Evolution – Enabling Process Knowledge Continuum from an Advanced Process Control Perspective

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

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

    Followed a Presentation by David Lovett, Managing Director & John Mack, Engineering Director at Perceptive Engineering
  • Engineering First Principles: Applications to Pharmaceutical Manufacturing
    Engineering First Principles: Applications to Pharmaceutical Manufacturing
    Bernard McGarvey, PhD Chemical Engineering Aug 24 2020 4:30 am UTC 65 mins
    Within the pharmaceutical industry, creating a robust Operational Control Strategy (OCS) is a key step to accomplishing the goals of Quality by Design (QbD). Along the way to developing this robust Operational Control Strategy many problems will be encountered that need to be solved. The use of a First Principles based approach provides value because it improves the effectiveness and efficiency of our problem solving, thereby leading to solutions that are more likely to work without unintended consequences and were created in a faster and more cost effective manner. Based on the author’s experience, a clear definition of what First Principles are will be given (and what they are not!). Areas of opportunity where the application of First Principles is likely to be successful will be described. An outline of a high-level process for implementing a First Principles based approach will be presented. Finally an example of the application of First Principles in the pharmaceutical industry will be briefly described.
  • Harnessing the Power of 3D Spheroids in Cancer Research
    Harnessing the Power of 3D Spheroids in Cancer Research
    Roxana Ghadessy, Ph.D. and Fiona Chang, Ph.D. Aug 25 2020 5:00 am UTC 60 mins
    In this joint webinar, Corning and Promega will present tools and solutions to support the continuous evolution of the spheroid model in 3D cell culture applications. Learn about how culture platforms optimized for single spheroid analysis or mass spheroid production can be coupled with novel real-time cell health assays and total RNA purification techniques. Furthermore, learn how to expand the spheroid workflow with downstream analysis of miRNA effects in cancer cell growth and metastasis.

    1. Turning the volume up on spheroid production with Corning Elplasia™ microplates - Roxana Ghadessy, Ph.D.

    Roxana is a Technical Marketing Manager for Corning Life Sciences, based in Singapore. In this role she is responsible for product awareness and education activities to highlight Corning’s workflow solutions in Cell Culture, Drug Discovery and other differentiated applications. Roxana has held previous roles in Sales and Product Management at Corning, BD Biosciences and Tocris. She received her Ph.D. degree in Pharmacology from the University of Bristol.

    2. A Complete Workflow for MicroRNA Analysis Paired with Novel Cell Health Assays for 3D Cultures - Fiona Chang, Ph.D.

    Fiona is an Applications Scientist at Promega Corporation, based in Singapore. She facilitates adoption of products by performing demonstrations, troubleshooting experiments, and giving trainings. Prior to joining Promega, Fiona received her Ph.D. in Biochemistry and Molecular Biology from Monash University, Melbourne. She has been working as a research fellow at the National University of Singapore before joining the Scientific Applications Group in 2018. Fiona has since been involved in applications in the Genomics, Genetic Identity, Applied Markets, Clinical Diagnostics and Cellular Analysis product areas.
  • Multiplica Tus Células, No Tu Trabajo: Cómo Escalar Cultivos Adherentes
    Multiplica Tus Células, No Tu Trabajo: Cómo Escalar Cultivos Adherentes
    Constanza Curotto Aug 26 2020 2:00 pm UTC 30 mins
    Corning y Aplicaciones en Bioprocesos: Células Adherentes - Parte1/3

    Un escalado eficiente es esencial en la producción de fármacos biológicos; el tipo celular, aplicación y espacio dictan cual es la plataforma más adecuada para cada proceso. En este Webinar haremos una revisión general de las plataformas de cultivo de Corning para células adherentes, y como estos pueden ser empleados para el escalado en aplicaciones de bioproduccion tales como producción de vacunas, terapias celulares y producción de vectores virales.

    Biografía del Expositor:
    Luego de graduarse como Bioquímico de la Universidad de Santiago de Chile, Constanza prosiguió su carrera en la industria farmacéutica veterinaria, desempeñándose como Científico de Bioprocesos tanto para el desarrollo de vacunas bacterianas y virales, estando a cargo de los procesos de escalado y generación de antígenos. Luego continuo su carrera en Bélgica, esta vez en el área de la producción de anticuerpos y proteínas recombinantes en sistemas celulares en suspensión, generando optimización de protocolos y experimentos de escalado.
  • Supporting students & researchers: Using the IR to respond to COVID-19
    Supporting students & researchers: Using the IR to respond to COVID-19
    Jean-Gabriel Bankier, Managing Director, Digital Commons Aug 26 2020 3:00 pm UTC 45 mins
    Universities face great COVID-related uncertainties. What can the library bring to the table to help with enrollment, the student experience, and support for research in an increasingly virtual environment? Many librarians are recognizing their institutional repository (IR) can bolster their university’s mission in times like these. Across the Digital Commons Community, we have seen dramatic increases in both interest from and submissions by authors as they look for better ways to share their works remotely. This 45-minute webinar will show you innovative trends on how the Digital Commons Community is using the IR to meet emerging COVID-related needs on campus:

    •Student recruitment and enrollment: providing prospective and incoming students an immersive view into research and scholarship opportunities
    •Student engagement and retention: providing hands-on ways for current students to participate virtually in academia
    •Research in a hybrid future: preparing the university for an easy switch to virtual conferences, virtual poster sessions and virtual exhibits
    •Critical information-sharing: providing a rapid way for faculty members to disseminate breaking primary research with global visibility

    The challenges of COVID-19 to higher education will be long-lasting. A robust repository program is a cornerstone for universities to maintain their presence in this new hybrid environment — and represents an opportunity to increase institutional reputation ahead of the curve.
  • Designing Quantum Materials using AI & Machine Learning
    Designing Quantum Materials using AI & Machine Learning
    Maria K. Chan, Alán Aspuru-Guzik and Stephen Gray Aug 26 2020 3:00 pm UTC 120 mins
    Artificial intelligence and machine learning (AI/ML) has sped up the discovery, synthesis, and characterization of quantum materials. The growth of this interdisciplinary field is driven by the collaboration of materials scientists, chemists, physicists, and more. This webinar will showcase advances from developing algorithms to understanding interactions in quantum materials to applying this knowledge in new technologies. Speakers will then discuss the interdisciplinary nature of AI/ML and collaborations with researchers, national labs, and companies.

    Maria K. Chan, Argonne
    Maria Chan obtained her PhD in Physics from MIT. Since 2012, Dr. Chan has been a staff scientist at Argonne’s Center for Nanoscale Materials. Her research focuses on the computational prediction of materials properties, using first principles, atomistic, and ML methods, particularly in applications toward energy technologies, such as energy storage, photovoltaics, catalysis, and thermal management.

    Stephen K. Gray, Argonne
    Stephen K. Gray is a Senior Scientist at Argonne’s Center for Nanoscale Materials. He has a PhD in Chemistry from UC Berkeley, and carried out post-doctoral work at Oxford and the University of Chicago. He is a Fellow of the American Physical Society, and his diverse research work is currently focused on modeling light-matter interactions in nanoscale materials, as well as hybrid materials for quantum information and quantum sensing.

    Alán Aspuru-Guzik, University of Toronto
    Alán Aspuru-Guzik is a Professor of Chemistry and Computer Science at the University of Toronto. He is a CIFAR AI Chair and CIFAR Fellow and Faculty member at the Vector Institute for Artificial Intelligence. He is interested in the intersections of quantum information and chemistry as well as the intersections of AI, automation and chemistry. He is a co-founder and officer of Zapata Computing, a quantum computing startup and Kebotix, a startup dedicated to self-driving laboratories.
  • Understanding Materials for Quantum Information Processing
    Understanding Materials for Quantum Information Processing
    Gary Wolfowicz, Sarabjit Banerjee and Danna Freedman Aug 26 2020 6:00 pm UTC 120 mins
    Breakthroughs in the fundamental physics and chemistry of quantum materials are key for emerging technologies in computation, information processing, and communication. Interdisciplinary teams must consider both the nature of the quantum states and materials as well as issues of engineering and scalability. In this webinar, the speakers will discuss their pioneering works in the field of quantum information processing, including the synthesis of new materials and characterization of their underlying physical processes. Speakers will then participate in a future-looking panel discussion about what fundamental and applied questions still need to be answered to advance the field.

    Gary Wolfowicz, Argonne National Lab
    Gary Wolfowicz obtained his PhD at Oxford in 2015 and is currently a scientist at Argonne National Laboratory. He has been exploring spin defect properties such as qubit coherence in semiconductors. His interest includes discovering and applying novel materials for quantum sensing and communication.

    Sarbajit Banerjee, Texas A&M University
    Sarbajit Banerjee is the Davidson Professor of Chemistry, Professor of Materials Science and Engineering, and Chancellor EDGES Fellow at Texas A&M University. His research interests are focused on electron correlated solids, electronic structure studies at interfaces, metastable materials, and energy efficient computation. He is a Fellow of the Royal Society of Chemistry and the Institute of Physics.

    Danna Freedman, Northwestern University
    Danna Freedman joined the Chemistry Department at Northwestern University in 2012, where she was recently promoted to Full Professor. Research in her group applies inorganic chemistry to challenges in physics, with emphasis on quantum information science, magnetic materials, and emergent phenomena. Notable accomplishments of the Freedman lab include the observation of millisecond coherence times in molecular qubit candidates and creating the first Fe-Bi bond in the solid-state.
  • Corning HYPER Technologies: Compact Solutions for Cell Scale-Up [GER. VERSION]
    Corning HYPER Technologies: Compact Solutions for Cell Scale-Up [GER. VERSION]
    Dr. Franziska Wienholz Aug 27 2020 9:00 am UTC 45 mins
    Efficient cell scale-up is essential in biologics and vaccine production to facilitate optimal product yields, whilst reducing footprint and manhours, Corning introduces the HYPER vessel technology. Corning HYPERFlasks and HYPERStacks are multilayer vessels incorporating proprietary gas-permeable film technology, resulting in high surface area to volume ratio. Using HYPER vessels, scientists can generate greater yields than traditional cell culture technologies, saving time, space and labor.

    In this webinar we will provide a general introduction of the HYPER technology, as well as technical applications in the fields of cell and gene therapy and viral particle production.

    About Presenter:

    Dr. Franziska Wienholz
    Franziska completed her Ph.D. in Molecular Genetics at the Erasmus MC,The Netherlands, focusing on studying DNA repair and related diseases. During her research, she acquired extensive knowledge on cell culture and patient-derived materials, molecular techniques, and genome editing.
  • Corning HYPER Technologies: Compact Solutions for Cell Scale-Up [FR. VERSION]
    Corning HYPER Technologies: Compact Solutions for Cell Scale-Up [FR. VERSION]
    Dr. Sonia Meconi Aug 27 2020 12:00 pm UTC 45 mins
    Efficient cell scale-up is essential in biologics and vaccine production to facilitate optimal product yields, whilst reducing footprint and manhours, Corning introduces the HYPER vessel technology. Corning HYPERFlasks and HYPERStacks are multilayer vessels incorporating proprietary gas-permeable film technology, resulting in high surface area to volume ratio. Using HYPER vessels, scientists can generate greater yields than traditional cell culture technologies, saving time, space and labor.

    In this webinar we will provide a general introduction of the HYPER technology, as well as technical applications in the fields of cell and gene therapy and viral particle production.

    About presenters:

    Dr. Sonia Meconi
    Sonia’s scientific background covers different fields such as biochemistry, cell biology, and immunology where she obtained a Ph.D., specifically in human infectious diseases working on a daily basis in a biologic level 3 lab. After a post-doctoral fellow and lecturer experience, she took over the head of the R&D and production teams in a small biotech which developed human serological diagnosis assays for infectious and autoimmune diseases. She oversaw pathogens (bacteria and virus) expansion supervision for protein microarray tests. Then, she joined an international company as an Application Specialist for cell culture and purification, creating new cell culture media dedicated to vaccines and cell therapy markets. Now, she joined Corning as Bioprocess Specialist working for different suppliers for the biopharmaceutical industry.
  • How to publish in groundbreaking journals
    How to publish in groundbreaking journals
    Steve W. Cranford, Editor-in-Chief, Matter Aug 27 2020 12:00 pm UTC 75 mins
    Would you like to learn tips for writing and developing a strong narrative for your work? Do you want advice on how to prepare your manuscripts for publication in the best journal for your research? Join us for a webinar with Steve W. Cranford, Editor-in-Chief, Matter to learn techniques and strategies to set yourself up for publishing success. Dr. Cranford will share details about the growth of multidisciplinary Cell Press journals and tips on developing your manuscript and will elaborate on his experience working with researchers throughout the publishing cycle. Join this engaging webinar and get answers to your questions in the Q&A session. Don’t forget to extend this invitation to your colleagues who might find this of interest.

    About Steve W. Cranford:
    A graduate from Memorial University (Canada), Stanford University (USA), and Massachusetts Institute of Technology (USA), Dr. Cranford was faculty at Northeastern University’s College of Engineering prior to accepting a new role as editor-in-chief for Matter.
    He has over 50 publications in the field of materials science in a range of high-impact journals, including Nature and Advanced Materials, with expertise in the area of atomistic simulation, computational modeling, and nanomechanics, encompassing a variety of materials systems, from carbyne to copper to concrete.
    He would have preferred to have published in Matter, but it didn’t exist. He constantly played with LEGO blocks as a child, likely leading to his interest in material assembly and structure.

    About the journal Matter:
    Matter, a sister journal to Cell, is a monthly journal encompassing the general field of materials science, from nano to macro and fundamentals to application. Recognizing that materials discovery and development facilitate groundbreaking technologies bridging multiple disciplines, Matter will embrace all significant advances in materials research, encompassing the previously unknown and the innovative.
  • Corning HYPER Technologies: Compact Solutions for Cell Scale-Up [SP. VERSION]
    Corning HYPER Technologies: Compact Solutions for Cell Scale-Up [SP. VERSION]
    Constanza Curotto Aug 27 2020 1:30 pm UTC 45 mins
    Efficient cell scale-up is essential in biologics and vaccine production to facilitate optimal product yields, whilst reducing footprint and manhours, Corning introduces the HYPER vessel technology. Corning HYPERFlasks and HYPERStacks are multilayer vessels incorporating proprietary gas-permeable film technology, resulting in high surface area to volume ratio. Using HYPER vessels, scientists can generate greater yields than traditional cell culture technologies, saving time, space and labor.

    In this webinar we will provide a general introduction of the HYPER technology, as well as technical applications in the fields of cell and gene therapy and viral particle production.
    About presenter:

    Constanza Curotto
    After graduating from Biochemistry in the University of Santiago (Chile), Constanza pursued directly a career in the Chilean Vaccine R&D industry, developing as a bioprocess scientist for both bacterial and viral vaccines in the field of animal health, being in charge of scale-up, and tech transfer with manufacturing plants. She furthered developed her career in Belgium as a bioprocess scientist, this time in the field of recombinant protein production, pursuing protocol optimization and scale-up experiments with suspension mammalian cell lines. Constanza is currently a field applications scientist in Corning for the EMEA region, providing customers with in-depth technical support, presenting seminars and trainings, and assisting customers in experimental set-up and troubleshooting.
  • Corning HYPER Technologies: Compact Solutions for Cell Scale-Up [ENG. VERSION]
    Corning HYPER Technologies: Compact Solutions for Cell Scale-Up [ENG. VERSION]
    Dr. Lindsey Parker Aug 27 2020 3:00 pm UTC 45 mins
    Efficient cell scale-up is essential in biologics and vaccine production to facilitate optimal product yields, whilst reducing footprint and manhours, Corning introduces the HYPER vessel technology. Corning HYPERFlasks and HYPERStacks are multilayer vessels incorporating proprietary gas-permeable film technology, resulting in high surface area to volume ratio. Using HYPER vessels, scientists can generate greater yields than traditional cell culture technologies, saving time, space and labor.

    In this webinar we will provide a general introduction of the HYPER technology, as well as technical applications in the fields of cell and gene therapy and viral particle production.

    About presenters:

    Dr. Lindsey Parker
    Lindsey completed her Ph.D. in Tissue Engineering and Regenerative Medicine at the University of Leeds (UK), validating a bioreactor for the application of mechanical stimuli to MSC. She subsequently joined UCL as an industrial KTP associate, leading clinical research in umbilical cord- derived MSC scale-up in collaboration with a tissue bank. Lindsey is currently a Bioprocess Sales Specialist at Corning, providing specialist support in bioprocess ranges, such as advising on product selection, custom products, and providing training.
  • Digital Pathology: Current and Future Benefits Using PD-L1 as the Paradigm
    Digital Pathology: Current and Future Benefits Using PD-L1 as the Paradigm
    Dr. Alex Haragan, Pathologist MRC Clinical Research Fellow at Royal Liverpool University Hospital, Liverpool, England Aug 27 2020 3:00 pm UTC 60 mins
    This webinar will give an overview of the Roche uPath software with particular regards to digital slide image viewing and the use of the PD-L1 immunohistochemistry interpretation algorithm. The pros and cons of digital pathology and uPath will be considered, with a focus on the use of the PD-L1 algorithm and how this can be used to augment pathologists' ability to interpret this tricky predictive biomarker in the context of NSCLC.
  • Multiplica Tus Células, No Tu Trabajo: Cómo Escalar Cultivos en Suspensión
    Multiplica Tus Células, No Tu Trabajo: Cómo Escalar Cultivos en Suspensión
    Constanza Curotto Aug 27 2020 4:00 pm UTC 30 mins
    Corning y Aplicaciones en Bioprocesos: Células en Suspensión - Parte 2/3

    Los procesos en suspensión juegan un rol clave en el mercado de biofarmacéuticos, donde sistemas celulares en suspensión son usados para producir anticuerpos y proteínas recombinantes. En este contexto, la selección de las plataformas de cultivo adecuadas favorece el uso eficiente del espacio, reduce costos y horas de trabajo. En este Webinar haremos una revisión general del portfolio de Corning para el cultivo en suspensión, aplicado tanto al ámbito de la investigación y desarrollo y producción. Apoyado además con datos experimentales generados por nuestros equipos de desarrollo.

    Biografía del Expositor
    Luego de graduarse como Bioquímico de la Universidad de Santiago de Chile, Constanza prosiguió su carrera en la industria farmacéutica veterinaria, desempeñándose como Científico de Bioprocesos tanto para el desarrollo de vacunas bacterianas y virales, estando a cargo de los procesos de escalado y generación de antígenos. Luego continuo su carrera en Bélgica, esta vez en el área de la producción de anticuerpos y proteínas recombinantes en sistemas celulares en suspensión, generando optimización de protocolos y experimentos de escalado.
  • Generando un Microambiente Óptimo en Todas las Etapas del Cultivo Celular
    Generando un Microambiente Óptimo en Todas las Etapas del Cultivo Celular
    Constanza Curotto Aug 28 2020 2:00 pm UTC 30 mins
    Corning y Aplicaciones en Bioprocesos: Medio de Cultivo y Suero - Parte 3/3

    El medio de cultivo y suero son componentes esenciales del cultivo celular – suministrando nutrientes y factores claves para las células – en ese sentido, seleccionar los productos óptimos es esencial.
    En este Webinar presentaremos una revisión general del porfolio de medio y suero de Corning, y como estos productos pueden ser usados en aplicaciones de bioprocesos para realzar tanto procesos de producción e investigación.
    El portfolio de Corning incluye:
    -Diversas formulaciones de medio estándar para requerimientos específicos
    -Medio libre de suero y medios especializados
    -Suero estándar y premium
    -Selección de suero especializado.

    Biografía del Expositor
    Luego de graduarse como Bioquímico de la Universidad de Santiago de Chile, Constanza prosiguió su carrera en la industria farmacéutica veterinaria, desempeñándose como Científico de Bioprocesos tanto para el desarrollo de vacunas bacterianas y virales, estando a cargo de los procesos de escalado y generación de antígenos. Luego continuo su carrera en Bélgica, esta vez en el área de la producción de anticuerpos y proteínas recombinantes en sistemas celulares en suspensión, generando optimización de protocolos y experimentos de escalado.
  • FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufa...
    FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufa...
    Dr Lily Koo, Consumer Safety Officer at FDA and Dr Keen Chung, Principal Scientist (Upstream Process) at Pall Biotech Aug 31 2020 4:30 am UTC 82 mins
    FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufacturing
    Presented by Dr Lily Koo, Consumer Safety Officer at Food and Drug Administration

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

    Followed by Process Control Strategy to Mitigate Contamination Risk of an Aseptic Viral Vector Production
    Presented by Dr Keen Chung, Principal Scientist (Upstream Process) at Pall Biotech

    Adeno-associated virus (AAV) vectors are potent gene therapy vectors, used to deliver therapeutic transgenes to target tissues. Gene therapy clinical trials often require high titer vector preparations to adequately deliver the therapeutic transgene, in great excess of research-level production utilized in many laboratories. To bring the virus into the pre-clinical and clinical phases, Pall Biotech simplified, optimized and scaled-up the current upstream and downstream process of viral vector production to industrial scales using the fully-closed, single-use Xpansion® multiplate seed train bioreactor and the production packed-bed iCELLis® 500 single-use bioreactor. In these processes, it is important to ensure that steps are built into the process to ensure adequate control of adventitious agents.
  • Cosun Test
    Cosun Test
    Cosun Test Aug 31 2020 1:00 pm UTC 30 mins
  • Qualification of Raw Materials Used in the Manufacturing of Cellular Therapies
    Qualification of Raw Materials Used in the Manufacturing of Cellular Therapies
    Jim Richardson, Sr Scientific Liaison at USP and Horst Ruppach, Ph.D. Scientific Director at Charles River Sep 1 2020 4:30 am UTC 79 mins
    Presented by Jim Richardson, Sr Scientific Liaison at United States Pharmacopeia

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

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

    After a short review of regulations/guidance related to viral safety aspects of raw materials the in principle concept for ensuring viral safety will be outlined. The viral risk profile of a raw material is defined based on the source material, the sourcing process and the subsequent manufacturing and/or purification process. Testing for viruses performed on the start material and/or process intermediates is one way to mitigate the viral risk. Different methods for testing will be presented and the pros and cons discussed. Analyzing the viral clearance capacity of the manufacturing process is another important strategy to reduce the viral risk significantly if applicable. There are, however, experimental challenges sometimes which makes it difficult to demonstrate efficient viral clearance even though the treatment is known to be highly efficient.
  • Application of USP 665 data to support qualification of single use systems
    Application of USP 665 data to support qualification of single use systems
    Ken Wong of Sanofi Pasteur, Desmond G. Hunt, of USP and James Hathcock of Pall Biotech Sep 1 2020 2:00 pm UTC 120 mins
    Application of USP 665 data to support qualification of single use systems


    Presented by Ken Wong, Desmond G. Hunt and James Hathcock

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

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

    Dr. Desmond G. Hunt has been with USP since 2005 and holds the position of Principle Scientific Liaison in the Compendial Science Group-General Chapters. He is the scientific liaison to the Packaging and Distribution and Dosage Forms Expert Committees, where he works to develop and revise USP Standards. He has authored many publications and peer-reviewed articles and is a frequent speaker and instructor on topics related to pharmaceutical packaging, particulate matter in parenteral and ophthalmic dosage forms and good storage and transportation practices. He participates on several industry Working Groups and Technical Committees related to his areas of expertise. Dr. Hunt obtained his M.S. and Ph.D. from the University of Texas at Austin and prior to joining USP, was a Research Fellow at the National Institutes of Health, Bethesda, MD, USA

    And Followed by an Industry Perspective presented by James Hathcock, PhD, Sr Director, Regulatory and Validation Strategy at Pall Biotech