Search results for " control"
Article
Current Innovations and Practices To Address Microbial Contamination in Downstream Bioprocessing
A multifaceted, collaborative approach is the key to addressing the multiple challenges of bioburden control. Improved ways of working in the manufacturing facility have been facilitated by supplier d…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
Optimal growth of cells requires monitoring and control of process variables such as pH, dissolved oxygen, dissolved carbon dioxide, and temperature. Arguably the most important and -crucial step in c…
Article
Work from Anywhere and Add Flexibility to Protein Purification Workflows
… system?
ÄKTA™ chromatography systems and UNICORN™ software feature remote control capabilities to support:
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Freedom to operate from anywhere
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Efficient collabor…
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…
Poster
Impact of sporicidal agent on MabSelect SuRe™ protein A resin lifetime
Hence, there is an interest in evaluating oxidizing agents with sporicidal activities, such as peracetic acid (PAA), in the control of such contaminants.
However, many of the protein-based chromat…
Article
From Darwin to Recombinant Fc Multimers
Damien Bataille from LFB presented how affinity chromatography with a novel chromatography resin, VIISelect, together with a QbD approach, delivered a robust process control strategy to deliver a high…
Article
Speed and Flexibility Are Dual Goals for Biopharma Operations
…ority representatives learn about the new systems during review of the chemistry, manufacturing, and controls (CMC) submission.
To expedite the review of new manufacturing technologies, FDA has…
Article
Ensuring the Biological Integrity of Raw Materials
Protocols for control of contamination in raw materials rely on cleaning and decontamination procedures combined with rigorous testing. These procedures are effective for most agents, but some organis…
Article
Evaluating E&L Studies for Single-Use Systems
…will occur; and the probability of detecting the leached substances through in-process manufacturing controls.
The risk analysis of each product contact material used in the process takes into ac…
Article
High-Throughput Process Development Handbook
In addition, steadily increasing demands from regulatory authorities for better understanding and control of manufacturing processes put even more pressure on development work. Employing high-throughp…