Group Working To Close 'Standards Gaps' For Cell And Gene Therapies
A group is coordinating the development of standards for cell and gene therapies in a congressionally mandated effort that could help manufacturers produce these therapies at commercial scale.
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A US FDA official is exhorting the biopharmaceutical industry to adopt standards to help in developing new cell and gene therapy products, yet this may pose difficulties as there is a lack of standards in this space, particularly in areas such as cell viability, chain of identity and viral vector gene quantification.
NIIMBL Issues Roadmaps For Advancing Gene Therapy, Vaccine And Antibody Drug Conjugate Manufacturing
A public/private manufacturing technology partnership has produced three roadmaps to help the biopharmaceutical industry navigate some of the regulatory and analytical hurdles in developing and manufacturing gene therapies, vaccines and antibody-drug conjugates. All three roadmaps cite a knowledge gap in the industry and the need for an adequately trained workforce.
Tmunity launched in early 2016 with $10m in seed funding for novel T-cell therapies, two of which are now in the clinic. The company reunites former Novartis cell therapy head Oz Azam and CAR-T researchers from the University of Pennsylvania.