Search results for " gene therapy"
Webcast
Viral Vector Production for Gene Therapy (in partnership with NIBRT)
In partnership with NIBRT, our eLearning course, “Viral Vector Production for Gene Therapy”, is available on the award winning NIBRT Online Academy.
Article
The Role of CDMOs in Cell and Gene Therapy Process Development
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An experienced contract development and manufacturing organization (CDMO) can ease scaling and tech transfer.
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
Bracing for a Future Wave of Advanced Therapies
Buoyed by the regulatory approval of several cell and gene therapy (CGT) products for difficult-to-treat diseases, the US biopharma industry is now bracing for a new wave of CGTs in the near future as…
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…