Search results for " gene therapy"

Article Design Considerations for a Commercial Cell and Gene Therapy Facility
The workflows of a cell therapy or a gene therapy differ from each other and from those of therapeutic antibodies, so the design and layout of the manufacturing facility must take these workflows into…

Article Mapping a Route for Cell and Gene Therapy Process Development
allogeneic cell therapies or gene therapy vs. cell therapy applications), the focus of scaling of the manufacturing process may be different. Scale up and mass production of the final product s…

Article The Evolving Role of Starting Materials in Cell and Gene Therapy
Earlier this year, FDA issued a statement revealing that there are already more than 800 active cell-based or directly administered gene therapy investigational new drug applications (INDs) currently …

Article Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Such advances, though, require further clarification of regulatory policies governing gene therapy production and quality assurance. FDA is considering at least three CAR-T applications, and mo…

Article FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
CBER is receiving dozens of applications to test new gene therapies, Marks reported at the Cell and Gene Therapy symposium in July 2018, sponsored by CASSS. He acknowledged that the logistics of manuf…

Article Bioterminology: A Guide to the Biopharmaceutical Lexicon
(See PAS)  CBER Center for Biologics Evaluation and Research at the FDA; CBER regulates vaccines, gene therapy, cellular products, allergenic extracts, antitoxins, antivenins, venoms, and blood an…

Article New Therapies Present Scaling Challenges
For a gene therapy, some aspects of its manufacturing process can use a scale-up strategy similar to a mAb, but other aspects of its manufacture cannot be easily be scaled up.  The cell therapy ch…

Article Emerging Therapies Test Existing Bioanalytical Methods
Questions include the following: · How much of a dosed gene therapy is present in circulation, in the target tissue, and how long does it stay there? · Is the target protein expression changed…

Article FDA Framework Spurs Advanced Therapies
Three new products were approved in 2017 by FDA, chimeric antigen receptor (CAR) T-cell cancer therapies from Novartis and Kite Pharma and a retinal gene therapy from Spark Therapeutics. Markets and M…

Article Patenting Prospects for Cell-Based Therapies
Cell-based therapies are moving medical treatments forward, but intellectual property uncertainties may delay progress. By Kevin Noonan Treatment using cell-based therapies is a rapidl…

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