Search results for " bioburden bioprocessing"
Article
Sanitization Opportunities for Protein A Resins
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Bacterial endospores present a challenge in bioproduction due to their resistance to common sanitization procedures using high concentrations of NaOH. Several protein-b…
Article
Cleaning Protein A Resins with 1 M NaOH
With increasing mAb titers, the impurity level of the cell culture feed increases. If not removed, these impurities can build up on the protein A resin and start to leach into the process material i…
Article
Process Chromatography: Continuous Optimization
Improved resin chemistries and customized separation solutions are enabling more efficient separations.
By Cynthia A. Challener
Cell-culture and fermentation are high-…
Article
Ensuring the Biological Integrity of Raw Materials
By Catherine Shaffer
Contamination with microbes, mycoplasma, viruses, and other adventitious agents can be a significant problem in biopharmaceutical manufacturing. Although contamination can o…
Article
Platform Approach Speeds Process Development
A modular cell-culture platform demonstrates accelerated process development.
By Harald Bradl, Jan Bechmann, Benedikt Greulich, Markus Michael Mueller, Patrick Schulz, Thomas Wucherpfennig
C…
Article
PDA's Technical Report for Biotech Cleaning Validation
The authors encourage biotech manufacturers to consult PDA Technical Report No. 49 for a detailed perspective on current practices and issues in biotech cleaning validation.
By Anurag S. Rathore, D…