Search results for " media"
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The Evolution of Supply Chain Security: Increasing Focus on Raw Material Variability
An increase in the development of biological and patient-specific drugs has also reinforced the demand for heightened raw material control.
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Mapping a Route for Cell and Gene Therapy Process Development
“For instance, the variation of transplanted CD34+ cells/kg can be up to four orders of magnitude around the median for autologous purposes. Strategies for autologous cell and gene therapy production …
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The Evolving Role of Starting Materials in Cell and Gene Therapy
The Evolving Role of Starting Materials in Cell and Gene Therapy
Accelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting m…
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New Therapies Present Scaling Challenges
In the roller bottle process, cells grow and attach to the surface of cylindrical bottles and are bathed in growth media as the bottle is rolled on a rack inside a temperature-controlled chamber. To i…
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Driving Improved Access to Biosimilars
Driving Improved Access to Biosimilars
New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying ri…
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Tools and Processes for Mature and Emerging Therapies
…rms, added options for upstream and downstream systems, and introduced equipment, supplies, columns, media, buffers, single-use systems, and ancillary equipment to promote process capabilities and re…
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Faster Flavivirus Vaccine Production
The approach helps determine which components in the media will have the most beneficial effect on cell growth. Surface Plasmon Resonance (SPR) analysis during process development provides data about …
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A Plastic Pipeline for Commercial Bioprocessing?
More than 75% use filled media bags, preassembled tubing sets, depth filters, bioreactors, sampling systems, and tangential flow filtration devices. Less than two-thirds use disposable chromatography …
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Leveraging Data for Better Biopharmaceutical Process Control
We have developed a soft sensor applications for GMP biomanufacturing in which media components quality attributes are related to upstream yields or bulk product CQAs (e.g., stability) (4,5).
B…
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Impurity Testing of Biologic Drug Products
Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
By Adeline Siew, PhD
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