WEBINARS AND VIDEOS

• 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. However, their use is less common in some modalities due to sample restrictions and the need for HTS expertise.

• 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.

• What's New for 2024: Dr. Nicole Verdun Offers a Look Inside The Office Of Therapeutic Products

  What is the Office of Therapeutic Products, where did it originate, and what's on its regulatory agenda for 2024?

• mRNA For Cancer Immunotherapy 2024 Outlook | Audience Q&A

  During our Cell & Gene Live, mRNA For Cancer Immunotherapy 2024 Outlook, our expert panelists answered audience questions regarding patient safety, foreseeable challenges in mRNA cancer immunotherapy for solid tumors, and much more.

• Supply Chain And Operational Challenges Facing mRNA

  Explore some of the biggest supply chain challenges facing mRNA cancer therapeutics and what short-term solutions may exist, starting with Chain of Custody/Chain of Identity.

• Bottlenecks And Manufacturing Challenges

  Expert panelists J. Andrew Case (Andy) and Daniel Getts cover the biggest bottlenecks facing mRNA cancer vaccine manufacturing today.

• Achieving Stability For mRNA

  Expert panelists for this Cell & Gene live event share some of things researchers are exploring to keep mRNA more stable.

• Major Advancements In mRNA

  Experts on this Cell & Gene live event discuss the major scientific biological advances in understanding the potential for mRNA-based immunotherapies vaccines for cancer over the last 2 years.

• Genentech, Myeloid's Approaches To mRNA Technologies

  Experts at a Cell & Gene Live event discussed the use of mRNA technology in cancer immunotherapy, including a brief overview of the different approaches being used to leverage mRNA technology.

• Quality Roundtable: Optimizing Biologics Manufacturing Processes With Raw Materials

  Improve your commercial manufacturing process with advice from regulatory and raw materials experts on the development journey from pre-clinical to licensure.

• Upstream To Downstream: A Comprehensive Approach To AAV Production

  How can you face the challenges of AAV production, scale up your AAV manufacturing effectively, and enhance the recovery and purity in your downstream processing.

• Scaling Viral Vectors

  Industry experts cover the high operational costs associated with viral vectors, along with the challenge presented by their shot shelf life and scalability.

• Overcoming Capacity Constraints

  How can CGT biotechs overcome issues such as building an in house facility and ultimately get their therapies to patients.

• Market Demand For AAV Vectors

  Here, Dave Maheu, VP, Head of Process & Analytical Development at Candel Therapeutics and Curran Simpson, Chief Operating Officer at REGENXBIO detail the key factors driving the adeno associated virus manufacturing market.

• An Active Release Mechanism For Magnetic Separation And Cell Isolation

  Discover an innovative active release solution that will serve autologous and allogeneic processes to the benefit of cell therapy patients.

• Regulatory Compliance And Viral Vectors

  Hear from experts who detail the specific regulatory challenges for advanced therapies, as well as how the regulatory requirements differ in early research and development in academia and in industrial vector production.

• Manufacturing Hurdles With Viral Vectors

  With a wide range of viral vector-based drugs already approved, viral vectors are expected to remain the primary delivery mechanism for the foreseeable future. However, as the demand for viral vectors increases, addressing the challenges related to their manufacture and scale-up is critical. In this segment, Dave Maheu, VP, Head of Process & Analytical Development at Candel Therapeutics and Curran Simpson, Chief Operating Officer at REGENXBIO share what they consider to be the most difficult challenges in vector development and manufacturing currently.

• Quality Control Assays

  Two company leaders detail not only the vectors their respective companies use and why but also the quality control assays performed on viral vectors.

• Optimize Cell Isolation And Activation For Flexibility And Scalability

  Learn about a first-of-its-kind platform technology that enables isolation and activation of T cells in one step using an active release mechanism for clinical trial or commercial manufacturing.

• Planning for Success: Supply Resiliency Strategies for Bench to Production

  Build scalable material sourcing strategies for R&D and early phases through to commercialization and learn how to accelerate the development process and ensure the scalability of your biologics.

• Driving Down COGS Audience Q&A

  Expert panelists provide detailed answers to questions submitted in real time by our registrants providing insightful responses regarding analytical challenges to automation, test automation, and more.

• Safety And Efficiency Of Source Material Collection

  Expert CTO's detail how automation improves safety and efficiency when collecting source material.

• Auto, Allo, And AI

  CTO experts debate autologous and allogeneic, and how automation improves the CAR-T cell process every step from collection to infusion. They also discuss the major ways AI optimizes automation.