Search results for " media" in Articles / App Notes
Article
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…
Article
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…
Article
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…
Article
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 …
Article
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 …
Article
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…
Article
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
CA-SSIS/shutterstock.comIm…
Article
Preclinical Evaluation of Product Related Impurities and Variants
This may be attributed to the complexities related to the use of cell lines, media formulation, and other bioprocessing steps that are prone to variability to varying degrees (4).
The inherent …
Article
Process Development: What May Lie Ahead in 2018?
…n Inspection
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Bioburden Control in the Biopharmaceutical Industry
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Impact of Media Components on CQAs of Monoclonal Antibodies
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Start with the End in Mind GMP Tech Tr…