Search results for " gene therapies"

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 Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
Recent technological developments have made available advanced fixed-bed bioreactors (FBRs) that allow the successful and cost-effective development and commercialization of gene therapies using adher…

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 The Role of CDMOs in Cell and Gene Therapy Process Development
Click here to read more >> An experienced contract development and manufacturing organization (CDMO) can ease scaling and tech transfer.

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…

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