Newsletter | May 1, 2024

05.01.24 -- Developing A Process Performance Qualification Master Plan


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Developing Process Performance Qualification Master Plans

This article provides considerations and a framework for a Process Performance Qualification Master Plan in the gene therapy industry. It is useful for sponsors with any level of experience.


Bridging The Gap Between Cell And Gene Therapy Promise And Practicality

Delve into the current challenges and opportunities of therapeutic targets, manufacturing processes, and regulatory frameworks for CGTs and realize the full potential of these revolutionary therapies.

Qualification Considerations For A ‘Factory-In-A-Box’

The cell therapy market is rapidly expanding into a multibillion-dollar industry, but its production is cost-prohibitive. Enter the "factory-in-a-box," which can be a game-changer.

Testing For Parenteral Packaging And Delivery Systems

There are many aspects to consider when developing a sound approach to performance testing to qualify packaging and delivery systems, and combination products.

mRNA/saRNA Manufacturing RNA Program Development And Support

Venkata Indurthi, Ph.D., shares his knowledge and experience with manufacturing RNA, including key upstream and downstream considerations for process development.

Enhancing AAV6 Vector Production For Cell Therapies

For the robust manufacturing of the serotype AAV6, the Pro10 production platform has proven reliability and scalability, making it suitable for meeting the demands of large-scale manufacturing.


Cell Sourcing: Apheresis Collections For R&D And cGMP

Smartly Scale iPSC To Benefit Human Health

CGT Analytical Services

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