Methods to Simultaneously Reduce Bioburden and Maintain Column Integrity, Explained Continuous bioprocessing is inevitably becoming the future of biomanufacturing. To date, several steps within a ...
On May 26, 2020, the U.S. Food and Drug Administration (“FDA” or “Agency”) issued an immediately in effect guidance, Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden ...
The Pharmaceutical Industry has a diverse set of products all with varying level of microbial risk to patients. On the low risk extreme there are topical pharmaceuticals on the other extreme are the ...
A key aspect of the validation of a sterilization process, irrespective of the sterilizing agent, is an understanding of the product bioburden. This understanding must be both quantitative and ...
As biopharma companies fine-tune their strategies for continuous bioprocessing, bioburden control has become a top priority. The approaches that worked for batch processing are inadequate for ...
Today, the U.S. Food and Drug Administration (FDA) issued guidance on the use of dry heat to help support the single-user reuse of certain particulate filtering facepiece respirators (FFRs), such as ...
MIDDLETON, Wis., Aug. 28, 2025 /PRNewswire/ -- Imbed Biosciences Inc., a leader in advanced wound care technology, today announced the launch of SAM™ PainGuard™ with Lidocaine, a groundbreaking ...
The National Academies of Sciences, Engineering, and Medicine are private, nonprofit institutions that provide expert advice on some of the most pressing challenges facing the nation and world. Our ...
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