Mapping cell and gene therapy manufacturing

Cell and gene therapy (CGT) is a diverse field, with products and processes as varied as the patients it is trying to treat. As a relatively new group, the Commercialization Workstream in the CGT Phorum began by creating maps of the manufacturing processes for CGT; and what originally started as an internal exercise has grown into a valuable project that could benefit not only member companies but the industry as a whole.

Creating the maps became a priority for the workstream because of the rapid growth in CGT products being developed with diverse processes across the industry, and the lack of standard technology platforms. The workstream members realized that a common language and terminology for the manufacturing processes were needed to improve familiarity, understanding and communication.

Scott Probst, Unit Head of Technical Development and Support at Bayer Pharma, explained, “There is a wide variety of therapy types manufactured by member companies and within each therapy type there are many different technology platforms or possible unit operations. Furthermore, participants from each company join with very different backgrounds, knowledge and experiences. It was necessary to define a common context in which we could discuss development or manufacturing challenges. The maps attempt to represent the spectrum of processes used within our CGT community and serve as a communication platform for our future collaborations.” The maps dedicated to CGT cell therapy and gene therapy will be published on the BioPhorum website in mid-2020. They will enable the similarities and differences of manufacturing strategies to be seen and will benefit a broad group of people across the industry by serving as an educational resource and an initial guide for deep-dive approaches. “For novices, the maps are a good place to start when trying to learn about manufacturing processes with which they are unfamiliar. They provide a preliminary orientation to folks who are just getting started and can help individuals start asking insightful questions faster,” said Probst.

Individuals with more experience in CGT will also benefit from the maps. “Experts will be able to appreciate the diversity of the approaches described in the maps, and will be able to start to leverage best practices, orthogonal approaches or different platforms and fold these into their current strategy for further optimization,” explained John Kerwin, Senior Manager, Gene Therapy Manufacturing Sciences at Biogen. Developing the maps has been a rewarding experience for the workstream members and has broadened their understanding of CGT approaches. “We have an opportunity to really move the needle and I think the BioPhorum group helps us to appreciate the large steps we have already taken, not only as individuals but also as a collaborative group,” said Kerwin.

“Working with other folks in BioPhorum expands the experience base and increases our exposure to different types of processes and technologies. It is also helpful to get the perspectives of others and benefit from the diversity of the groups.”

SCOTT PROBST, UNIT HEAD OF TECHNICAL DEVELOPMENT AND SUPPORT AT BAYER PHARMA

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