Search results for "bioprocess"
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
Clinton Weber is associate director of BioProcess Sciences, Ashok Kumar is principal scientist, Lisa Joslin is process validation manager, and Roland Ashton, James Schmid, and Michael Larson are devel…
Article
Flexibility in Biopharmaceutical Manufacturing
The history of bioprocessing drug substances has been such that mono-facilities were built to produce large volumes of single blockbuster products. The business environment has changed and biofaciliti…
Article
Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
BioProcess Int 24:30-38 (2011)
4. Application Note: Scale-up of adherent Vero cells grown on Cytodex microcarriers
using ReadyToProcess equipment, Cytiva, 29-0435-48, Edition AA (2013)
5. …
Article
Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
Howard Levine, President and Principal Consultant of BioProcess Technology Consultants, about what these guidelines mean for developers of biosimilars. Dr. Levine is based in Woburn, Massachusetts, in…
Article
PDA's Technical Report for Biotech Cleaning Validation
DEGRADATION EFFECTS
A key consideration in bioprocessing is that the active ingredient is usually degraded by cleaning processes that involve hot, aqueous, alkaline cleaning solutions. Although th…
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