Bioburden testing serves a variety of purposes, and the relevance of the data can range from relatively insignificant to extremely critical. Bioburden tests can be used for general tracking or ...

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 ...

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 ...

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 ...

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 ...

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 quality of water for pharmaceutical production (purified water, water for injection, and ultrapure water) is quantified and regulated through four parameters – total organic carbon (TOC), ...

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 ...