Search results for " Biopharm"
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Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
… of business resilience, at AstraZeneca Biologics to get the latest on performing risk management in biopharmaceutical manufacturing.
Risk Assessment Challenges in Biopharma
BioPharm: What to…
Article
Critical Quality Attributes Challenge Biologics Development
By Susan Haigney
Critical quality attributes (CQAs) are used in biopharmaceutical development to gain an understanding of a product and the processes used to make that product. The International C…
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Continuous Manufacturing: A Changing Processing Paradigm
Presenters of a BioPharm International webinar, “The Future of Continuous Downstream Bioprocessing,” cite continuous biomanufacturing initiatives at an Amgen Singapore plant as an example of how manuf…
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QbD and PAT in Upstream and Downstream Processing
Girard (Spinnovation): The underlying concept for QbD of an upstream bioprocess is that the desired quality of the biological or biopharmaceutical product is assured every time. CQAs vary for each cel…
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Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
…Continuous manufacturing
Transcript
BioPharm International: Welcome to the BioPharm International expert interview on analytical considerations for successful upstream process de…
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Leveraging Data for Better Biopharmaceutical Process Control
By Agnes Shanley
Upstream biopharmaceutical manufacturing has always depended on process measurements, because precise levels of nutrients and oxygen must be monitored closely to e…
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Fluid Handling in Biopharma Facilities
By Susan Haigney
Contamination prevention in biopharmaceutical manufacturing is crucial, and the proper handling and storage of fluids is essential to limit the possibility of contamination. Facili…
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What’s In a Name? For Biosimilars, A Lot
Hernandez, "What’s In a Name? For Biosimilars, A Lot," BioPharm International 28 (6) 2015.
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Challenges in Analytical Method Development and Validation
The manufacture of biopharmaceuticals presents some unique challenges when ensuring product quality and patient safety. Analytical testing can provide the data needed to produce a safe and effective d…
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A Closer Look at Affinity Ligands
In speaking with BioPharm International®, Phillip Elliott, PhD, associate director of Process Development, BioCina; Jan Bekker, PhD, director, Business Development, Commercial and Technical Operations…