Search results for "bioburden downstream"
Article
Process Development: What May Lie Ahead in 2018?
2018 is shaping up to be an interesting year in the world of biopharmaceuticals. What have 2017 developments taught us, and what may lie ahead for biopharmaceutical drug developers and process engin…
Article
Efficient Sodium Hydroxide Sanitization with a Novel Procedure of AxiChrom™ Columns Packed with Chromatography Resin
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Sodium hydroxide (NaOH) cleaning-in-place is the widely accepted method of sanitization employed by biopharmaceutical manufacturers to avoid the excessive costs and delays of a…
Article
Microbiological Testing: Time is of the Essence
Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing methods.
By Cynthia A. Challener
Effective microbiological testing during biopharmace…
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Digitalization: The Route to Biopharma 4.0
Industry 4.0, also known as the Fourth Industrial Revolution (4IR), will result in the digital transformation of the manufacturing sector. It is propelled by transformative trends such as the prolif…
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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-…
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Re-use of Protein A Resin: Fouling and Economics
Mar 01, 2015
By Anurag S. Rathore, Mili Pathak, Guijun Ma, Daniel G. Bracewell
BioPharm International
Volume 3, Issue 28
In the past two decades, Protein A affinity chromatography ha…
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…
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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…
Article
Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
The biopharmaceutical industry continues to expand in new and exciting ways. What might be in store for 2019, and what important lessons should process developers take from 2018? Here, we look back …
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…