Search results for " Cell and gene therapies"

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 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 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 Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
This article will explore the traditional path from the laboratory to the clinic and how the fixed-bed technology provides an alternative solution to meet commercial demands. By Alex Chatel and

Article Best Practices for Selecting a Top-Quality Cell Line
Irina Shi - Stock.Adobe.com Leveraging automation and a step-by-step approach are keys to success. By Cynthia A. Challener Cell lines determine the performanc…

Article FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies More consistent and reliable production processes are critical for advancing innovative treatments. By Jill Wechsler …

Article Cytiva and 4Tune Engineering Collaborate on Cell Therapy Quality Risk Management
“Our collaboration with Cytiva will provide their customers with an automated, systematic, and user-friendly approach to risk management that will improve lifecycle management of cell and gene therapi…

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 Production of Recombinant Adeno-associated Virus Vectors Using Microcarrier Culture of HEK293T Cells
As of March 2020, more than 4310 gene therapy clinical trials have been performed worldwide, with only 518 of them in Phase III and Phase IV. As the gene therapy projects enter clinical Phase III or g…

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.

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