Search results for " novel therapy"

Article Scaling Up Novel Therapies
Scaling Up Novel Therapies Platform processes have improved monoclonal antibody scale-up. Can they do the same for personalized therapies? By Agnes S…

Article New Therapies Present Scaling Challenges
New Therapies Present Scaling Challenges Manufacturing differences between traditional mAb therapies and newer biotherapeutics dictate whether processes should be scaled up, scaled out, or use an al…

Article FDA Framework Spurs Advanced Therapies
Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies. By Cynthia A. Challener Ibreakstock/Shutterstock.co…

Article Mapping a Route for Cell and Gene Therapy Process Development
While cell and gene therapies differ in many ways, some of the best practices for process development and validation are similar. By Cynthia A. Challener …

Article Science Focus Fuels Successful Process Development for Startups
Getting the science right helps biopharma startups overcome development and commercialization challenges. By Cynthia A. Challener sdecoret/Stock.Adobe.com Pr…

Article Gene Therapies Push Viral Vector Production
Gene Therapies Push Viral Vector Production Viral vectors show promise as a delivery mechanism for gene therapy, but which virus types are commercially viable? By Feliza Miraso…

Article FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies More consistent and reliable production processes are critical for advancing innovative treatments. By Jill Wechsler …

Article Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
This article will explore the traditional path from the laboratory to the clinic and how the fixed-bed technology provides an alternative solution to meet commercial demands. By Alex Chatel and …

Article Biopharma Seeks Balance
Biopharma Seeks Balance Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science. By Rita C. Peters …

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 …

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