Final FDA guidance replaces 2011 potency testing advice, asking CGT makers to build potency assurance from IND filing through postmarket monitoring.
|Articles|February 15, 2020
- BioPharm International-02-15-2020
- Volume 2020 eBook
- Issue 1
Using the “Cubic Effect” to Drive Cell and Gene Therapy Commercialization
Author(s)Alberto Santagostino
Contract partners must help innovator biotechs consider manufacturability as early as possible in development. This requires focusing on technical and operational performance, as well as cost.
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The cell and gene therapy industry is at a major inflection point, as therapies move out of clinical trials and into the commercial market. As more therapies are commercialized and become established, demand for cell and gene therapies will grow, leading to vast changes in patient care.
Article Details
BioPharm International
eBook: Outsourcing Resources, February 2020
February 2020
Pages: 12–15
Citation
When referring to this article, please cite it as A. Santagostino, “Using the “Cubic Effect” to Drive Cell and Gene Therapy Commercialization," BioPharm International Outsourcing Resources eBook (February 2020).
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Biopharma Contract Market Updateover 6 years ago
Building Strategic Relationships with CROsover 6 years ago
Digitalization: A CDMO’s Perspectiveover 6 years ago
More Capacity and Technology Translate to More Optionsover 6 years ago
Sourcing Success in Cell and Gene Therapy Developmentalmost 7 years ago
Growth in Biologics Market Inspires OutsourcingAdvertisement
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