Search results for " advanced therapies" in Articles / App Notes
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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…
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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…
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Bracing for a Future Wave of Advanced Therapies
In 2023, the agency established the Office of Therapeutic Products (OTP), a new “super office” structure that was transitioned from the former Office of Tissues and Advanced Therapies (OTAT). OTP was …
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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…
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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…
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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
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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…
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Future Downstream Process Development Solutions for Advanced Therapies
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Peter Guterstam, PhD, Product Manager of Next Generation Resins & Technologies at Cytiva, provides insight into solutions for ad…
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Working With Advanced Therapeutics: You Bring the Idea, We Bring the Map
We all know these advanced therapies hold huge potential. But developing them isn’t straightforward, and failing too late can be costly. At Cytiva, we’ve spent decades helping scientists turn vision i…
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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…