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…

Article 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…

Article 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 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 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…

Article Scaling Up Novel Therapies
However, with novel products such as cell therapy, the costs of production can be so high (e.g., including the cost of reagents for cell adherence and culture), that the whole process itself is essent…

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