Search results for " microbial contamination"
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
Mar 01, 2015
By Randi Hernandez
BioPharm International
Volume 3, Issue 28
Aggregation in biopharmaceuticals remains a major concern and threatens the stability of a product. Protein …
Article
Technologies and Practices Must Evolve to Meet Demand
Regulatory issues and microbial contamination, however, were of greater concern for the 2015 survey participants. Producing high enough product yields, purifying high product yields, and protein aggre…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
Newer classes of biotherapies will require innovations in processing technology.
By Glen R. Bolton, Bernard N. Violand, Richard S. Wright, Shujun Sun, Khurram M. Sunasara, Kathleen Watson, Johna…
Article
Single-Use for Downstream Chromatography: Benefit or Hindrance?
Single-use technology is gaining ground in downstream bioprocessing, but challenges stall further adoption.
By Feliza Mirasol
ARTMOIS/STOCK.ADOBE.COM
Biopharmaceutical manufactu…
Article
Prepare for an FDA Bioburden Inspection
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Not sure how to best approach a bioburden problem when an FDA inspection is imminent? Anastasia Lolas, former FDA Biologics License Application (BLA) revi…
Article
Optimizing Late-Stage and Commercial Cell-Culture Processes
Optimizing Late-Stage and Commercial Cell-Culture Processes
Late-stage and commercial biomanufacturing pose a challenge to cell-culture processing.
By Feliza Mirasol
…
Article
Understanding Validation and Technical Transfer, Part 3
Understanding Validation and Technical Transfer, Part 3
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies. Part 1 |…
Article
Chromatography Scale-Up: Don’t Get Tied Down by Bed Height
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When scaling, you can make better use of existing chromatography columns while avoiding overcapacity.
Keeping a constant residence time is a well-est…
Article
Industry Adoption of Single-Use Systems Remains Low
Single-use technologies are starting to gain ground as capacity needs change, but industrywide adoption remains low.
By Feliza Mirasol
zli…
Article
Prepare for an FDA Bioburden Inspection
Even with effective prevention, bioburden incidents can occur. A best-practices response will not only help you be prepared for any upcoming FDA inspection, it may also yield valuable insights to help…