The International Society for Cellular Therapy (ISCT) is a global society of clinicians, regulators, technologists, and industry partners with a shared mission to drive the translation of all cell and gene therapies for the benefit of patients worldwide. The ISCT 2023 Annual Meeting took place in Paris, France from May 31 to June 3 2023. DDW’s Megan Thomas heard from attendees about key trends in the sector. First, the importance of cell collections. In subsequent articles, themes include allo vs auto, new generation MSCs, future regulatory changes and redefining manufacturing.
Veerle d’Haenens, General Manager Global Therapeutic Systems and Cell Therapy Technologies at Terumo Blood and Cell Technologies, told DDW that today’s approved therapies can be a next-in-line or even a last-resort treatment for patients with critical illnesses. The process of isolating patient or donor immune cells involves several steps and can be costly and time-consuming – taking up to four days. This time is, of course, crucial for patients. She said: “Improving the apheresis cell collection process aims to shorten development timelines and produce better CGTs that help patients faster. During ISCT, we hosted a roundtable on sources of variability in apheresis. An important learning shared by the panelists was the importance of communication between the apheresis centre and developers which will help close the gap on the collection characteristics needed to support the manufacturing success rate.”
Carole Nicco, Chief Scientific Officer of BioSenic, noted that cell collections help us to evaluate the potential of a wide type of cells and from different donors. She said: “Each donor is in fact different and the allogenic cell therapy needs more than one healthy donor to be established.” She also commented that while cell collection is important, no one knows how long the stability lasts. “This makes CGT difficult to manufacture and to bring to the market.”
Ravi Nalliah, Chief of Product & Strategy of TrakCel, said that an area that TrakCel has been working closely with customers on is the process of cell collection and ensuring that this is managed as well as possible within the other constraints of the supply chain (often resource related). He said: “The collections play a pivotal role in CGT development and rely on the isolation and modification of specific cell types which are then re-infused back into the patients. The cell collection process is invasive and time-consuming for a patient with many constraints that need to be managed. Patient health at the time of the collection needs to be factored in, which requires careful planning around the disease severity, patient comfort and logistics such as manufacturing, courier, and staff availability. In addition, the time between collection and manufacturing is tightly controlled with factors such as expiry which need to be considered and managed, so it is very complex. Integrating systems that manage this specific element of the supply chain with a CGT focus will be critical as the industry scales up.”
Becky Cap, SVP, Business Development, Advanced Therapies at BioBridge Global, said that for years, researchers and developers have viewed cell collections as a commodity. “Just give me a bag of cells”, she says. “Not all collectors have the depth of expertise to support such a request. Some of those experts can be found in community blood banks where you have a naturally distributed, network of collectors. Our 50-year history of collecting blood and tissue products allows us to serve therapeutic development partners well.”