Search results for " gene therapy"

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…

Article Scaling Up Novel Therapies
Although these treatments are in early stages of development, gene therapy has already become a reality, with companies such as Spark Therapeutics. The company received “breakthrough therapy” status f…

Article Science Focus Fuels Successful Process Development for Startups
…prietary systems can provide significant advantages, particularly in nascent fields such as cell and gene therapy,” he remarks. “The systems we have implemented have tremendous advantages over commer…

Article Biopharma Seeks Balance
Developing sufficient quantities of a gene therapy for thousands of patients in a clinical trial would be cost-prohibitive, said Marks. Manufacturing processes need to be more productive for biopharma…

Article Tools and Processes for Mature and Emerging Therapies
Backing from the investment community in innovator companies and investments by major contract development and manufacturing organizations in cell and gene therapy capacity are strong indicators the b…

Article Transformative Medicines Challenge FDA and Manufacturers
Transformative Medicines Challenge FDA and Manufacturers New gene therapies and combination products require innovative regulatory approaches. By Jill Wechsler …

Article Flexible Facilities for Viral Vector Manufacturing
While the initial project looked at a monoclonal antibody (mAb) facility, the team plans to extend the concept to cell and gene therapy production. Cytiva has amassed expertise in modular design a…

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