Search results for " advanced therapies"

Article FDA Framework Spurs Advanced Therapies
This program is designed to expedite the development and review of regenerative medicine advanced therapies and is managed by FDA’s Center for Biologics Evaluation and Research (CBER). Applicants that…

Article Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Gottlieb noted in early July 2017 that manufacturers have filed nearly two dozen requests for RMAT designation, and that CBER’s Office of Tissues and Advanced Therapies (OTAT) had granted four. Simila…

Article GMP Challenges for Advanced Therapy Medicinal Products
“ATMPs are complex pharmaceuticals, for which traditional approaches may not be possible,” Paula Salmikangas, chair of the EMA’s committee for advanced therapies (CAT), told an European Directorate fo…

Article Remote Monitoring and Big Data Advance Upstream Automation
Connected, integrated bioprocessing enterprises with greater data analytics capabilities are coming. By Cynthia A. Challener As upstream processing drives toward higher efficiencies in meeti…

Article Advances in Engineering of Protein-Based APIs
Advances in Engineering of Protein-Based APIs New platform technologies, advanced modeling tools, and addressing patient needs are important developments. By Cynthia A. Challener …

Article The Need for Advanced Process Modeling for New Therapeutic Biologics
The Need for Advanced Process Modeling for New Therapeutic BiologicsThe trend toward personalized medicines includes more complex manufacturing cycles that can benefit from advanced process modeling e…

Resource Advanced Cell Therapy Technology Fast Trak Course (CELLT1)
This free webinar gives an overview of cell and gene therapy manufacturing and what the current landscape looks like.  

Article Cytiva Advances Fiber Chromatography Technology with New Launch
The launch of HiScreen Fibro PrismA, the company’s newest product for early mAb purification process development strengthens Cytiva’s new fiber-based Protein A platform. On Jan. 27, 2021, Cyti…

Article Advancing QbD in the EU
EU authorities are stepping up their efforts to incorporate QbD principles. The European Commission (EC) and the European Medicines Agency (EMA), have been supporting quality-by-design (QbD)…

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…

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