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CELL AND GENE THERAPY MANUFACTURING

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Mitigating Risk In Process Automation

Two Chief Technical Officer's for therapeutic organizations cover the various ways in which automation helps to reduce risk and why closing systems and reducing the number of manual manipulations is so critical.

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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.

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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.

1:02 Process Liquids And Buffers Offering
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.

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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.

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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.

1:47 24_01_CGL_FDA_Webinar_Seg10-min
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.

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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.

4:12 24_01_CGL_FDA_Webinar_Seg09-min
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?

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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.

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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.

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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.

6:59 Thermo Fisher Scientific Large Volume Liquid Expansion
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.

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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.

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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.

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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 s...

3:22 24_01_CGL_FDA_Webinar_Seg11-min
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.

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Pipeline Progress

Experts working on robust pipelines that focus on various therapeutic areas explain how process automation looks different per therapeutic focus area.

16:47 Thermo Fisher Scientific Bio-Expo Live 2024 Downstream Bioprocessing
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.

8:44 24_01_CGL_FDA_Webinar_Seg13-min
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.

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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.

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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.

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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.

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Safety And Efficiency Of Source Material Collection

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

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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.

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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.

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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.

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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.

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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.

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Overcoming Capacity Constraints

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