Search results for " bioburden control"

Article Selecting a Comprehensive Bioburden Reduction Plan
Targeting Bioburden BioPharm: What type of planning is necessary to target all aspects of bioburden reduction? Mittelman and Anicetti (PDA task force): The most important consideration in biob…

Article Bioburden Control in the Biopharmaceutical Industry
Good Practices in the Biopharmaceutical Industry Because bio/pharmaceutical products are generally intended for ill populations, bioburden control throughout the whole manufacturing plant should b…

Poster Infographic: Sources of Bioburden You May Have Missed
Biopharmaceutical manufacturing has a natural risk of contamination. What can you do about it? The problem with traditional mAb manufacturing is that there are so many potential entry points for…

Article 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 Sources of Bioburden You Might Have Missed
A problem with traditional mAb manufacturing is that there are so many potential entry points for microbial contamination. There are, however, ways to shut the door on contamination. The risk …

Poster A Next Generation Protein A Chromatography Resin for Improved Productivity and Bioburden Control
mAb production using a Protein A capture step has followed a highly successful synergistic path the last 30 years. There are, however, remaining challenges. • The increased upstream titers in mA…

Article Bioterminology: A Guide to the Biopharmaceutical Lexicon
Bioterminology: A Guide to the Biopharmaceutical Lexicon This lexicon was generated by the editors of BioPharm International magazine. Please feel free to email your suggestions for terms that s…

Article Challenging the cleanroom paradigm for biopharmaceutical manufacturing of bulk drug substances
The process fluid is often filtered for bioburden control within a controlled amount of time after completion of any open process step. Sanitization: To make sanitary by cleaning and disinfection,…

Article Quality by design for biotechnology products—part 2
Second in a three-part series that discusses the complexities of QbD implementation in biotech development. By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman…

Article QbD and PAT in Upstream and Downstream Processing
To gain perspective on the implementation of quality by design (QbD) and process analytical technology (PAT) in biopharmaceutical processing, BioPharm International spoke with Clinton Weber, as…

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