Search results for "biopharm"
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
Jul 01, 2015
By Susan Haigney
BioPharm International
Volume 28, Issue 7, pg 34–36
BioPharm International spoke with Stephan Krause, director of quality assurance, Laura Jeannel, asso…
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…
Article
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…
Article
QbD and PAT in Upstream and Downstream Processing
UPSTREAM PROCESSING
BioPharm: In implementing QbD, what would you identify as the critical quality attributes (CQAs) in a typical upstream bioprocess using cell-culture?
Vanden Boom (Hospi…
Article
Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
…25 - PAT
10:35 - Continuous manufacturing
Transcript
BioPharm International: Welcome to the BioPharm International expert interview on analytical considerations f…
Article
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…
Article
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…
Article
What’s In a Name? For Biosimilars, A Lot
BioPharm International spoke to USP to find out a bit more about how the naming process for a drug occurs and who truly will have the final say when it comes to biosimilar nomenclature.
Naming for…
Article
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…
Article
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…