Search results for " cell and gene therapy"
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The Evolving Role of Starting Materials in Cell and Gene Therapy
Based on this forecast, the industry expects cell and gene therapy products to surge in the market and remain a prominent part of the pharmaceutical industry for years to come (2).
FDA has devel…
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Mapping a Route for Cell and Gene Therapy Process Development
Strategies for autologous cell and gene therapy production must therefore be sufficiently robust to enable the development and implementation of effective in-process controls,” he states.
The proc…
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Design Considerations for a Commercial Cell and Gene Therapy Facility
“Reliable sourcing and quality standards are key considerations when selecting single-use systems for cell and gene therapy because they are often not designed with these therapies in mind,” points ou…
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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 …
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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…
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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…
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Optimizing your Cell Culture Process to Improve Productivity
Other companies that we support are in the cell and gene therapy industry. The companies that support biopharma’s such as contract manufacturing organizations or CMOs are participating in cell line or…
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Cytiva and 4Tune Engineering Collaborate on Cell Therapy Quality Risk Management
Our customers will have peace of mind knowing they have a strong risk mitigation process in place,” said Catarina Flyborg, vice-president, Cell and Gene Therapy, Cytiva, in a company press release.
…
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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…
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Future-proof your AAV process with a complete producer cell line – just induce and grow
Stable producer cell lines helped to make mAb therapies the powerhouses they are today. To deliver on the promise of AAV-based gene therapy for prevalent diseases, we need similar technology. …