An industry first – unifying the release standards for CGT endonuclease ancillary materials

30 May 2023
Advanced Therapy Medicinal Products
Victoria Mwanza
Senior Global Change Facilitator

The cell and gene therapy (CGT) industry is a rapidly evolving area with novel therapeutic solutions to complex diseases. The ancillary materials used in these therapies are increasingly just as novel as the modalities themselves. However, there is a commonality in some of the critical genetic process steps performed at the manufacturing scale, and therefore opportunities to improve process efficiency, safety, and product quality.

The materials used in genetic bioprocessing steps are led by commercially available Serratia marcescens-derived endonucleases that are recombinantly expressed from different host cell systems. Although these are commonly used in CGT, there is a lack of defined release test criteria throughout the pharmacopeial and regulatory landscape.

This is why we have published Cell & gene therapy: A proposal to align release standards for endonucleases used in nucleic acid removal, which contains a proposed framework for testing and releasing these endonucleases. It should help close the gap in the lack of guidance and potentially accelerate new therapies in the clinic.

“This is an industry first in unifying the release standards for cell and gene therapy ancillary materials,” said Daniel Blake, Engineer, Global Manufacturing Sciences at Biogen.

A common language

A universal standard will harmonize and support CGT product development to ensure higher quality and safety standards before commercialization. For a global adoption, we suggest these recommendations are added to dedicated references in the European and US pharmacopeias. It would also mean that whether you are a manufacturer, supplier, or client, you can use the same language and refer to an agreed reference table and testing. Importantly, when you file with regulatory authorities, you would also have a data pack covering what they expect to see and demonstrating you are managing and controlling that material appropriately.

“Recombinant Serratia marcescens endonucleases were the focus of the team’s initial interest,” said Andrew Schaefer, Raw Materials Manager, Analytical Method Development at Eurofins BioPharma Product Testing. “We found through our survey of phorum members that these enzyme reagents were common across a variety of manufacturing processes, but the expectations for testing of these materials were unclear. Our hope is to stimulate dialog with a broader industry audience to come to a consensus not only for Serratia marcescens endonucleases, but potentially other enzymes used in manufacturing.”

Nobody has tried to unify the endonuclease release testing needed for CGT processes, so our approach breaks new ground. However, with the explosive growth of the CGT industry, the need for these release specifications is loud and clear.

If you would like to help shape this important part of the CGT industry, please comment on the questions in this paper and add points for discussion to support the development and use of an endonuclease testing standard.

For more information, download the paper here and contact Victoria Mwanza, Lead Global Change Facilitator, at

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