October 27, 2022 -- The cell and gene therapy (CGT) industry is growing and academic contract development and manufacturing organizations (CDMOs) -- like their larger commercial counterparts -- are playing a critical role in the ecosystem, according to Stuart Curbishley, PhD, head of business and process development at the University of Birmingham’s Advanced Therapies Facility.
Science Advisory Board spoke with Curbishley earlier this month at the 2022 Cell & Gene Meeting on the Mesa in Carlsbad, CA, about the manufacturing challenges facing the sector including an industry-wide dearth of skilled workers and the need for CGT workforce education and training.
While the manufacturing capabilities of small academic CDMOs like the University of Birmingham are limited in scale and are perhaps better suited for early-stage clinical trials, Curbishley contends that they nonetheless provide essential services.
"Our expertise is in taking early-phase trials through to phase IIb ready for that next step," Curbishley said. "We really try to build processes, even for preclinical, that are fit to translate through to later stages. I think that's an area that as a sector we need to get smarter at -- getting those processes right the first time."
The University of Birmingham's Cell Therapy Suite, a clean room facility licensed by the U.K.'s Medicines and Healthcare products Regulatory Agency for the manufacture of Advanced Therapeutic Medicinal Products and the Human Tissue Authority for the production of cell- and tissue-based therapies, is one of just a few such facilities in the U.K.
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