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 ...

Note: This article is based on the white paper "Establishing Bioburden Alert and Action Levels" available for download. Most national and international standards regarding bioburden, sterilization, or ...

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 ...

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 ...

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 author reviews test methods for microbiological cleaning processes and suggests ways to improve microbial bioburden method suitability studies. Surface microbial bioburden monitoring methods are ...

The author clarifies the definition and objectives of overkill sterilization for steam sterilization cycles. Current sterilization practices are reviewed and the validation difficulties associated ...

Fully cell-free process aims to further democratize personalized cancer therapeutic manufacturing with shorter turnaround times and negligible bioburden and endotoxin risks. As late-stage PCT clinical ...