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 ...

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 ...

A company's contamination-control plan is an important document designed to formalize the rationale, methods, and validation of contamination-control procedures in a manufacturing facility. The author ...

When sterilizing medical devices, sterilization personnel rely on bioburden counts as part of determining and maintaining the sterilization process. In the following Q&A, Martell Winters, senior ...

Lonza Pharma & Biotech and Innosieve Diagnostics announced today an exclusive distribution agreement for rapid bioburden testing technology. This agreement expands Lonza’s extensive offering of ...

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 ...

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 ...

The Global Bioburden Testing Market has experienced consistent growth, with a compound annual growth rate (CAGR) of 12-15%. This growth is driven by tightening regulatory standards and an increasing ...

Dublin, Nov. 21, 2024 (GLOBE NEWSWIRE) -- The "Bioburden Testing Market Size, Share and Trends Analysis Report by Product (Consumables, Instruments), Test, Application, End-use, and Region 2024-2030" ...

Marketresearch.biz reports that the Rising investments by companies on R&D in lifesciences and increasing product recalls due to microbial contamination are other factors driving growth of the target ...