Search results for " microbial" in Articles / App Notes
Article
Optimizing Late-Stage and Commercial Cell-Culture Processes
“There is also a renewed interest in non-mammalian cell-based expression systems for manufacturing antibody mimetics and novel scaffolds, for example, and we continue to develop and refine our microbi…
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
Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I
This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…
Article
Sanitization of ÄKTA™ pilot 600 Using Sodium Hydroxide
In a microbial challenge test, parts were exposed to a bacterial strain recommended by the United States Pharmacopoeia (USP 38) and to yeast strains commonly used in production environments. Sanitizat…
Article
Industry Adoption of Single-Use Systems Remains Low
“We have also launched a high-performance single-use microbial fermentor at the 500-L scale. In addition, we have also launched a single-use ÄKTA ReadyFlux ultrafiltration/defiltration system,” h…
Article
Preclinical Evaluation of Product Related Impurities and Variants
Two case studies—one involving a microbial therapeutic product (granulocyte colony stimulating factor)—and other—a mammalian therapeutic monoclonal antibody (bevacizumab) have been used to illustrate …
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…
Article
How to Address Bioburden Challenges: Insights and Tips
Bioburden control is an area of serious concern for anyone making mAbs or other biologicals. Manufacturers’ efforts to avoid microbial contamination are today being complemented by developments from…
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
It minimizes the risk of microbial growth, increases product stability with extended shelf life, eliminates agitation and foaming during transportation, and increases flexibility during manufacturing …