WEBINARS AND VIDEOS

• Simplify Your Downstream Calculations With Bioprocessing Downstream Calculators

  Simplify complex biopharma downstream processing tasks using a suite of powerful, web-based calculators designed to streamline workflows and automate intricate mathematical modeling.

• Reimagine Sustainability In Bioprocessing

  Achieving sustainability in bioprocessing labs presents distinct challenges. Learn how to reduce your environmental footprint while maintaining efficiency and avoiding extensive re-validation efforts.

• Navigating Global Regulatory Landscapes In An Evolving Biopharma Industry

  Minimize regulatory risks and ensure compliance in the evolving biopharma sector. Watch this on-demand discussion for insights on change management, supplier collaboration, and future market trends.

• 2025 CGT Regulatory Outlook | Audience Q&A

  Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Medicine, and Chief Regulatory Officer of International Society for Cell & Gene Therapy (ISCT) answer questions from the audience. They covered key regulatory topics, including the FDA’s process for finalizing draft guidances, the status of INTERACT meetings, and the use of the term “critical component” in manufacturing regulations.

• Navigating Global Regulations, Equity Challenges, And The Future Of Patient Access

  Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Medicine, and Chief Regulatory Officer of International Society for Cell & Gene Therapy (ISCT) continue the discussion to explore the complexities of expanded access programs (EAPs) in CGT, highlighting global regulatory differences, ethical concerns, and accessibility challenges.

• How The FDA's 2024 Draft Guidances Will Influence CGT Regulation In 2025

  Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Medicine, and Chief Regulatory Officer of International Society for Cell & Gene Therapy (ISCT) share why the FDA’s 2024 draft guidance documents are expected to shape regulatory standards for cell and gene therapy in 2025, with topics ranging from safety testing of allogeneic cells to manufacturing practices and the use of human and animal-derived materials.

• How The New Administration Could Shape FDA Oversight, Compliance, And Guidance In 2025

  Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Medicine, and Chief Regulatory Officer of International Society for Cell & Gene Therapy (ISCT) share why the new administration may influence the regulatory landscape for cell and gene therapy, particularly regarding enforcement actions against unproven stem cell products and challenges to FDA authority at the state level.

• How The FDA Strengthens Industry Collaboration

  Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Medicine, and Chief Regulatory Officer of International Society for Cell & Gene Therapy (ISCT) explain why the FDA is signaling a stronger commitment to dialogue with sponsors and advancing cell and gene therapies, particularly through early-stage engagement and regulatory guidance. Key initiatives include enhanced pre-IND meetings, increased guidance document cross-referencing, and a focus on addressing potency challenges.

• Key Regulatory Challenges, Innovations, And Opportunities For CGT In 2025

  Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Medicine, and Chief Regulatory Officer of International Society for Cell & Gene Therapy (ISCT) detail how the regulatory landscape for cell and gene therapy in 2025 will continue to be shaped by advancements in science and manufacturing and evolving regulatory guidance.

• Congruence And Divergence In Global Regulatory Approvals

  Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Medicine, and Chief Regulatory Officer of International Society for Cell & Gene Therapy (ISCT) explain how regulatory standards for cell and gene therapy approvals are largely consistent across regions, with North America typically leading in approvals, followed by Europe and then Asia.

• Tools For Efficient Downstream Processing Of Antibody-Based Therapeutics

  Watch and discover how to effectively utilize chromatography tools for improved purification of therapeutic monoclonal antibodies and antibody derivatives.

• Process Development With Chromatography Resins And Expert Support

  Watch a Senior Product Manager discuss insights on emerging challenges and advanced downstream purification solutions for biologic therapeutics with chromatography resins, expert knowledge, and dedicated support.

• Efficient Downstream Processing Of Antibody-Based Therapeutics – A CDMO Perspective

  Discover efficient downstream processing strategies for antibody-based therapeutics. Explore key considerations and trade-offs in purity, yield, speed, and cost, from a CDMO perspective.

• Quality Roundtable: Raw Material Planning For Tech Transfer And Scaling Biologics

  Join this roundtable of biopharmaceutical professionals as they share their insights to help you navigate important quality and planning decisions for the progression of your biologic.

• Rapid Process Development And Technical Support For AAV Scaleup

  Accelerate your AAV production journey. Learn how rapid process development and expert support can streamline your path from vial to purified bulk, ensuring scalable and efficient manufacturing.

• mAb Up- And Downstream Process Intensification Strategies

  Discover how to reduce monoclonal antibody (mAb) manufacturing time and costs through process intensification. Learn about continuous perfusion, ultrahigh cell density banks, and more.

• The Role Of Peptones In Boosting Quality And Yield

  Peptones can significantly boost CHO cell bioprocessing. We analyze their impact on diverse CHO cell lines using real-world data to assess their effects on titer, protein quality, and cell growth.

• Analytical Solutions To Help Accelerate Bioprocessing Success

  Unlock the power of data-driven bioprocessing. Discover how advanced analytics can optimize your cell culture process, improve performance, and accelerate success.

• Scalable Production Of Lentivirus For Research To Commercial Manufacturing

  Join our webinar on scaling the CTS LV-MAX System in bioreactors, covering transfection scalability, Thermo S.U.B. advantages, and DynaSpin’s efficient gene therapy integration.

• The Way Forward: Supply Chain Solutions

  Learn how to build a resilient supply chain to navigate today's complex environment. Expert speakers share insights on optimization, innovation, and strategic planning to meet evolving market conditions.

• Innovative Contamination Control: Enabling Integrity And Efficiency

  An integrated approach can enhance contamination control, boost process efficiency, and ensure the production of high-quality cell therapy products.

• The Role of Peptones In Enhancing Efficiency

  Discover how peptones enhance vaccine manufacturing efficiency with valuable insights into cost-effective solutions, variability control in biologically derived materials, and more.

• Maximize Quality Assurance Through Rapid Sterility Testing

  This webinar explores mitigating the risk of product loss, and production delays, as well as the critical role rapid sterility testing plays in ensuring the quality and safety of cell therapy products.

• Accelerating mAb Process Development In The Growing Therapeutics Market

  The market for mAbs and mAb variants is growing rapidly. Explore the latest strategies and advancements in early stage mAb up- and downstream process development.

• Scalable By Design: Streamlining Cell Culture Media Manufacturing

  Learn ways to help improve quality, simplify technology transfer of proprietary media formulations, and mitigate logistical challenges associated with custom media scale-up processes.

• Thermo Fisher Scientific Bio-Expo Live 2024: Downstream Bioprocessing

  Review downstream process tools from Thermo Fisher Scientific to enable optimal biologics purification, including chromatography resins, chemicals, process liquids, and buffers.

• Thermo Fisher Scientific Bio-Expo Live 2024: Upstream Bioprocessing: A Next-Gen Medium And Feed System

  This presentation reviews next-generation cell culture media and feed options and a recent successful scale-up case study done in collaboration with Centre for Biochemical Engineering and Cell Cultivation Techniques at the Zurich University of Applied Sciences.

• Accelerate Process Development With HTS Chromatography Tools

  High Throughput Screening (HTS) chromatography tools can accelerate process development and reduce material usage. Learn about a solution that addresses challenges with their use in new modalities.

• Next-Gen Medium And Feeds System To Improve CHO Cell Line Productivity

  Choose the right CHO medium and feed system to optimize your upstream processes and secure a seamless scaling up.

• Unlocking The Future Of Allogeneic Cell Therapy For Oncology | Audience Q&A

  Expert panelists in this Cell & Gene Therapy Live presentation provided detailed responses to questions about the potential risks of CAR-T therapy, screening criteria for donor material, comparability, and more.

• Autoimmune Disease Research's Impact On The Development Of Cell Therapies For Oncology

  Recently, many cell therapy companies have been pivoting to autoimmune diseases. Expert panelists discuss whether they think there are any learnings or potential headwinds these pivots could provide to cell therapies for oncology.

• Defining The CMC / Clinical Relationship For Allogeneic Cell Therapies

  During this segment, Nguyen and Wagner define why the relationship between CMC and Clinical is so critical, and they also explain what a mutually beneficial partnership between CMC and Clinical looks like.

• Improvements In Scaling And Sequencing For Allogeneic Cell Therapies For Oncology

  During this segment, Nguyen and Wagner agree that scalability will be a top concern for most CGT companies.

• Best Practices For Effective Donor Management

  Starting with high quality donor material is critical for allogeneic cell therapy drug manufacturing, and this requires laying the groundwork for a high-touch, end-to-end donor pool management strategy.

• Major Trends Impacting Allogeneic Cell Therapies For Oncology

  We kicked off this Cell & Gene Live, Unlocking the Future of Allogeneic Cell Therapy for Oncology by discussing the major trends impacting allogeneic cell therapies for oncology.

• Process Liquids And Buffers Offering

  Whether you are a researcher, scientist, or industry professional, this video will provide valuable insights into our large volume liquids manufacturing capabilities.

• Thermo Fisher Scientific Large Volume Liquid Expansion

  This video provides an insightful look into the expansion of the large volume liquids manufacturing site at the Grand Island facility, highlighting the various stages of the manufacturing process and the capabilities it offers to support the bioprocessing industry.

• What Is The DynaChrom™ Single-Use Chromatography System?

  This chromatography system offers a flexible solution, paired with an advanced software platform, allowing easy integration with downstream process automation.

• 2024 Regulatory Outlook With Dr. Peter Marks And Dr. Nicole Verdun | Audience Q&A

  Experts on the Cell & Gene Live event, 2024 Regulatory Outlook, answer questions about topics including pediatric development in rare diseases, diversity planning for ultra-rare disease, anticipated approvals by 2025, and more.

• Collaborating with the FDA: Dr. Peter Marks and Dr. Nicole Verdun Share Advice For Small And Emerging Biotechs

  In this segment, Dr. Peter Marks and Dr. Nicole Verdun share their advice and best practices for small and emerging biotechs when working with the FDA.

• Understanding AI And Machine Learning's Impact On CGT with Dr. Peter Marks and Dr. Nicole Verdun

  During this segment, Dr. Peter Marks and Dr. Nicole Verdun share their take on how AI and machine learning will impact FDA regulation in 2024.

• The Need for Speed: Dr. Peter Marks and Dr. Nicole Verdun Explain Meeting Unmet Need for Pediatric Patients

  How can sponsor companies accelerate development in pediatric patients for genetic diseases that affect both children and adults, but where gene therapy holds the greatest promise to address unmet needs in pediatric patients?

• Dr. Peter Marks on the Adoption of Novel Precision Analytics

  Hear advice for developers who are worried that the FDA will not accept changes in their process that include a new analytical method.

• CMC Comparability: Transitioning to Commercial Manufacturing with Dr. Nicole Verdun

  In this segment, Dr. Nicole Verdun shares some of the challenges demonstrating CMC comparability during late-stage product development (i.e., pivotal or Phase 3 clinical trial) that occur while transitioning to commercial manufacturing.

• Patient Data's Impact On CMC Robustness

  When CGT products demonstrate dramatic improvements with minimal safety concerns in a Phase 2 study, sponsors may want to modify the protocol mid-study to increase patient enrollment.

• Dr. Peter Marks Talks a Standardized Playbook for Gene Therapy Manufacturing

  In this segment, Dr. Peter Marks shares developments in CMC for advanced therapies in the near future.

• Why Clinical Requirements Change: Dr. Peter Marks on Pre-IND Meeting Pathways

  Learn how clinical requirements change after the FDA and a company agree on a pathway during a pre-IND meeting and how the company might recover as a result.

• Race To The Regulatory Finish Line: Dr. Nicole Verdun Talks Efficiencies In Platform Technologies

  Could a platform approach help certain therapies make their way over the regulatory finish line more efficiently?

• Focal Points for 2024: Dr. Verdun and Dr. Marks Talk Regulatory Challenges for Cell-Based Therapies

  Dr. Verdun and Dr. Marks provide detailed feedback on the regulatory challenges facing cell therapy and explain the Agency’s most important focal points for 2024, patient accessibility, and more.

• How Past Gene Therapy Approvals Are Shaping the Future with Dr. Peter Marks

  In this segment of Cell & Gene Live, Dr. Peter Marks shared what he and his team have learned from current gene therapy approvals to accelerate future approvals.