Release specifications for master cell banks – your chance to make a difference

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Gene therapy (GT) is a rapidly expanding field that could potentially revolutionize curative treatments and is an exciting new way to help patients. The number of GT processes is wide and varied, yet current regulations and guidance are not always detailed enough for industry needs.

Industry is looking for initiatives to increase the speed of learning and, ultimately, influence regulatory agencies when creating guidance and policies around GT development and manufacturing.

That is why BioPhorum has published Gene Therapy Critical Starting Material: A discussion to help establish release specifications for master cell banks of parental host cells.

The paper proposes a platform framework for testing master cell banks (MCBs) of two origins for use in GT – human origin used for the generation of adeno-associated virus or lentivirus, and insect origin used for the generation of adeno-associated virus.

“Having a publication like this available can serve as a great resource for cell and gene therapy CMC project teams early on in development,” said Carlos A. Benitez, Scientist, Purification Process Development at Sanofi. “I’m encouraged by the thought that this paper could help to harmonize MCB release testing across the industry and advance the cell and gene therapy CMC space going forward.”

The paper aims to gain feedback on the proposed testing practices – this is where you can play a part!

Use your influence

The team has created a confidential, industry-wide online survey for you to give open and honest feedback on the survey questions and raise points of your own that can help develop this platform approach.

The survey questions include ‘Which attributes should be tested when monitoring phenotypic stability of master cell banks?’ and ‘When monitoring phenotypic stability of master cell banks, what is your sample size (e.g. 1% of the bank)?’.

This is an opportunity for you to have your say and help shape the future direction of this work. Your input will help develop an industry-wide consensus on the testing currently required for MCBs and for the future direction that this testing could take.

Achieving this consensus means industry will have an aligned and confident approach when dealing with regulatory bodies and presenting data around this critical starting material. It will drive forward industry’s shared knowledge and, ultimately, influence regulations and guidance in this area.

When developing the framework, the team used many group discussions and a blinded survey to share data and opinions. The final proposal is a combination of thoughts, suggestions and questions from more than 20 companies.

David Colton, Director, Quality Assurance at Sangamo Therapeutics, said, “We hope that bringing so much industry knowledge together to standardize the approach to cell bank testing for cell and gene therapy will help improve quality and efficiency.”

The team plans to present the paper at industry conferences and hold a webinar for an interactive discussion – watch this space! The survey is available electronically and as a downloadable document that can be returned to  This is an excellent opportunity to use your knowledge and experience to help develop release specifications for MCBs – why not share your thoughts?

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