Search results for "cell therapy"
Article
Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
The necessity to detach cells from a culture substrate during cell harvesting remains one of the most challenging steps in a cell-culture process.
By Marcos Simon, Juan J. Giner-Casares
Cell…
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
By Leonard P. Freedman, Mark C. Gibson, Richard M. Neve
Irreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays and increased costs of …
Article
Taking a “Development-by-Design” Approach to Cell Therapies
More CDMOs are entering cell therapy market niche
Demand for specialized cell therapy manufacturing and development services is also growing, and has attracted Lonza Bioservices, Cognate BioService…
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FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
While there is great excitement over the potential of CAR-T (chimeric antigen receptor) cell therapy to target and activate T cells to eliminate a cancerous or other undesirable cell type, Marks cauti…
Article
Bioterminology: A Guide to the Biopharmaceutical Lexicon
Bioterminology: A Guide to the Biopharmaceutical Lexicon
This lexicon was generated by the editors of BioPharm International magazine. Please feel free to email your suggestions for terms that s…
Article
Patenting Prospects for Cell-Based Therapies
For example, the NurOwn cell therapy product (Brainstorm Cell Therapeutics, Inc.) is comprised of autologous mesenchymal stem cells (MSCs) modified to express neurotrophic factors, shown to promote mo…
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Downstream Processing for Cell-Based Therapies
By Qasim A. Rafiq, Fernanda Masri
With increasing numbers of advanced therapies—including cell and gene therapies—entering early- and late-stage clinical development, significant focus has been …
Article
Science Focus Fuels Successful Process Development for Startups
… developing cell therapies for immuno-oncology and autoimmune indications using its proprietary SQZ cell therapy platform, also known as cell squeezing. “There are no established protocols for how to…
Article
FDA Framework Spurs Advanced Therapies
… is “direct evidence of the commercializing potential of CAR-T therapies” and indicates that “cell therapy is now a sector that has emerged today, not evolving in the future” (2). ISCT also expects t…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Bryan Silvey, senior director for quality compliance at Kite Pharma, emphasized that personalized cell therapy production, utilizing a “one lot-one patient” manufacturing platform with a 15-d…