Name: Getting a Gene Therapy Product to Market: Pitfalls and How to Prevent Them
Start: 2021-07-08T18:57:00Z
End: 2021-07-08T18:57:34.000Z
Location: BrightTALK
Rating: 4

Thermo Fisher Scientific connects you with the technical expertise, regulatory guidance, and custom or off-the-shelf solutions you need to overcome obstacles, streamline processes and advance your cell and
gene therapies.

The transformative potential to change the way human disease is treated using cell and gene therapy has motivated rapid technological advancements towards streamlining manufacturing processes. Standardization via automation and introduction of quality control via closed system manufacturing will contribute to overcoming barriers and facilitate the reach of this treatment to broader patient populations.

In this webinar, Decentralized Manufacturing: Enabling Scalable and Cost-Effective Point of Care for Cell and Gene Therapies, industry leaders from the University College London and Thermo Fisher Scientific discuss the evolution of the industry and where it's headed. You'll learn about drivers and challenges associated with decentralized manufacturing, how streamlined processes can enable scalable point of care, and closed, modular, automated cell therapy workflow solutions.

Enabling Scalable & Cost-Effective Point of Care for Cell & Gene Therapies

Cell therapy is a transformative cancer treatment that utilizes genetically modified cells from a healthy donor or patient's own immune system to attack cancer cells, but manufacturing these cells represents a major challenge for the industry. Although every therapy and process are different, there are a few key decisions that are critical to the success of any advanced therapy medicinal product (ATMP) and for the success of the company that plans to bring them to the clinic. 

In this webinar, we will discuss three key areas to consider when you’re preparing to commercialize a cell therapy: starting/raw material, controlled manufacturing process, and testing safety & quality. You'll learn about regulatory requirements for GMP ancillary materials for cell and gene therapy, closed-system manufacturing and how it can improve overall productivity and product safety, and characterization and lot release testing, proper validation for regulatory CMC filing.

A Successful Journey to Cell Therapy Manufacturing: From R&D to Lot-Release

Thermo Fisher Scientific product experts discuss upstream and downstream solutions across the entire workflow.

In this webinar, you'll learn about scalable, high-titer AAV production using 2 different producer cell platforms - Mammalian HEK293F based suspension system and an insect Sf9 cell line, ExpiSf9 suspension system, the benefits of utilizing a specifically engineered affinity chromatography resin in the downstream purification of AAV, regulatory requirements for safety and purity testing during the AAV production process, and how implementing automated systems helps save time and demonstrates product quality and safety.

Scalable AAV Manufacturing: Addressing Challenges Across the Workflow

This webinar covers regulatory requirements for GMP ancillary materials and the importance of regulatory documentation and support. Considerations for scalability, consistency of supply and commercial use rights to help you to commercial manufacturing.

GMP Ancillary Materials for Cell & Gene Therapy Manufacturing: What to Consider

In this webinar, industry leaders from Thermo Fisher Scientific, Viralgen, and Hemology Medicines Inc. discuss the lessons learned to get a gene therapy product to market. They discuss the common pitfalls and how to avoid them. You'll learn about common gene therapy development pitfalls and how to avoid them, cost-effective and robust transitioning through the clinic to commercial manufacturing, how to develop a scalable analytics strategy for gene therapies, and more.

Getting a Gene Therapy Product to Market: Pitfalls and How to Prevent Them

Biopharma

Pharmaceutical

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Getting a Gene Therapy Product to Market: Pitfalls and How to Prevent Them

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Thermo Fisher Scientific