Issue 201
It’s no secret that the demand for cell and gene therapies is growing. But what should the industry prioritize to improve manufacturing?
In a recent article for The Medicine Maker, Krishnendu Khan suggested the need for a complete overhaul of cell therapy manufacturing. Why? Because existing processes are not equipped for large batches. More specifically, Khan believes new solutions in fill-finish packaging strategies could alleviate some of the issues. He also discussed the topic of closed versus open systems.
Though closed systems offer advantages, such as contamination prevention, they also have high costs and limited scalability. Open fill-finish processes could provide flexibility for allogeneic therapies, but the contamination risks would need to be considered.
Khan ultimately believes the decision to choose closed, open, or even hybrid systems must consider the delicate balance between safety, accessibility, and scalability. “By leveraging the advantages of both approaches, researchers and clinicians can optimize the safety, accessibility, and efficacy of evolving cell therapies.” Read more here.
Until next week,
Jamie Irvine | Associate Editor
Essential Reading
UK Funding Boost
The Cell and Gene Therapy Catapult (CGT Catapult) is set to receive £80 million in funding as part of Innovate UK’s £1.6bn Catapult programme – an initiative aimed at supporting therapy commercialization, manufacturing, delivery, and workforce training. The ongoing agreement will facilitate the CGT Catapult’s activities until March 2028 and represents a 35 percent increase compared with the previous five years.
CAR-T development
Researchers at Ecole Polytechnique Fédérale de Lausanne’s School of Engineering say they have developed CAR-T cells that can “flourish” in tumor environments. The study suggests that adding another layer – namely, the molecule IL-10 – to the CAR-T cell therapy can create a supercharged immune cell that is particularly efficient at targeting and destroying tumor cells. The IL-10 molecule was widely regarded as an immunosuppressant, but their findings suggest CAR-T cells, which excrete the IL-10 molecule, are positively ingested by the modified T cells. Simply put, the cell is able to produce its own medicine to keep healthy in the tumor's hostile environment.
Worth Your Time...
Research
Bayer AG and Asklepios BioPharmaceutical complete phase Ib clinical trial for AB-1005 – a gene therapy for Parkinson’s disease.
Researchers report interim results from phase I/II trial of gene therapy containing codon-optimized human SGCB transgene against Limb-girdle muscular dystrophy.
Study suggests CAR-T re-expansion warrants close clinical attention and laboratory investigation to mitigate lethal risk.
Business
Senti Biosciences reduces workforce by approximately 37 percent to enable increased focus on SENTI-202, a Logic Gated investigational cell therapy for acute myeloid leukemia
Ginkgo Bioworks announces the completion of a gene therapy collaboration to improve AAV production titers for Biogen's gene therapy manufacturing processes.
Elicera Therapeutics AB’s collaborative CAR-T project with Vecura at Karolinska University Hospital and Uppsala University receives SEK 850,000 (~$85,000) award from Sweden’s Center for Advanced Medical Products.
