Search results for " contract manufacturing"
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Managing Biomanufacturing Capacity Expectations
“Either the manufacturing process was not as robust as the sponsor thought it was, or the tech transfer failed to successfully convey all subtleties to the contract manufacturing organization [CMO].” …
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New Therapies Present Scaling Challenges
Bioprocessing equipment and materials suppliers—as well as contract manufacturing organizations—are racing to develop suitable tools and processes to meet the manufacturing demands of these personaliz…
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Biopharma Advances Demand Specialized Expertise
Jun 15, 2015
By BioPharm International Editors
BioPharm International eBooks
Volume 28, Issue 13
Contract service providers share insights on biopharma market developments and the impl…
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Reducing Cross-Contamination Risks in Process Chromatography
Reducing Cross-Contamination Risks in Process Chromatography
Single-use systems provide replaceable fluid paths.
By Cynthia A. Challener
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Manufacturers Struggle with Breakthrough Drug Development
Accelerated testing and production create challenges in documenting product quality.
Biopharmaceutical companies are eager for FDA to designate potential test therapies as “breakthrough drugs…
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Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
Today, many Chinese companies are expanding through biosimilars, contract manufacturing organization (CMO) partnering, and other means to reach Western markets. For example, China’s WuXi Biologics, a …
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Strategizing for Rapid Changeovers in Biologics Manufacturing
Olivier Le Moal/Stock.Adobe.com
By Cynthia A. Challener
Facility and equipment design are important, but the team and its experience matter most.
Through its Operation Warp Speed pro…
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Flexible Facilities for Viral Vector Manufacturing
Single-use and modular systems will meet demand for rapid implementation at different scales.
By Jennifer Markarian
Industry experts have noted that there are limitations in the…
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A Plastic Pipeline for Commercial Bioprocessing?
Pressure to get drugs to market faster, the smaller batch sizes characteristic of targeted therapies, and the comfort level biopharma companies and contract manufacturing organizations (CMOs) have wit…
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Mapping a Route for Cell and Gene Therapy Process Development
While cell and gene therapies differ in many ways, some of the best practices for process development and validation are similar.
By Cynthia A. Challener
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