Search results for "Gene Therapies" in Articles / App Notes

Article Gene Therapies Push Viral Vector Production
In general, there are two types of gene therapies, namely ex-vivo and in-vivo, Chaudhary points out. “In ex-vivo, cells are modified outside the patient’s body and the corrected version is transplante…

Article Design Considerations for a Commercial Cell and Gene Therapy Facility
By Feliza Mirasol With the recent FDA approvals and commercialization of cell and gene therapies in the US market and a pipeline of cell and gene therapies progressing toward regulatory review, …

Article Mapping a Route for Cell and Gene Therapy Process Development
Challener The regenerative medicine field is still quite young, and companies developing commercial processes for the production of cell and gene therapies face several hurdles. These product…

Article The Evolving Role of Starting Materials in Cell and Gene Therapy
By Brad Taylor, Dominic Clarke The number of product approvals for cell and gene therapies is rising steadily. Earlier this year, FDA issued a statement revealing that there are already…

Article Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Manufacturing Standards Key to Advancing Cellular and Gene Therapies FDA works with industry on strategies for assuring high-quality regenerative medicines. By Jill Wechsler …

Article FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
CBER is receiving dozens of applications to test new gene therapies, Marks reported at the Cell and Gene Therapy symposium in July 2018, sponsored by CASSS. He acknowledged that the logistics of manuf…

Article Getting Ahead of the Game in Cell and Gene Therapy
Successes in the clinic have placed many cell and gene therapies on an accelerated route to market. But unless developers consider, at an early stage, how they might produce their product at scale, th…

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 New Therapies Present Scaling Challenges
By Feliza Mirasol The approval of emerging biologic-based therapeutics—such as cell and gene therapies—presents challenges and decisions for drug companies looking to increase the manu…

Article Emerging Therapies Test Existing Bioanalytical Methods
Cellular and gene therapies are not new to the medical establishment. Cellular therapy, the transfer of live cells with a specific function to a patient to treat/cure a disease, was first successfully…

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