Search results for " control" in Articles / App Notes
Article
Modern Manufacturing Key to More Effective Vaccines
CBER also encourages manufacturers to meet with FDA staff to address chemistry, manufacturing, and controls (CMC) issues before filing an application.
Robin Levis, deputy director of OVRR’s Div…
Article
Connected Polishing and Concentration Under One Automation Method
This work aims to demonstrate the capability of the UNICORN™ system control software to integrate these unit operations to eliminate intermediate hold steps thereby releasing resources and reducing ov…
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Participants explored strategies for analytical method development, assay validation, product characterization, specification setting, and for establishing relevant manufacturing controls for these hi…
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Development and Future of Protein A Chromatography Technology: Q&A with Jonathan Royce, Business Leader Chromatography Resins, Cytiva
Now, 1M NaOH can in fact be used, improving the bioburden control, and the binding capacity is now up to 80 g/L. With an increased binding capacity and new high-flow agarose bead design, the productiv…
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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…
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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…
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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…
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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
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…