Search results for " microbial contamination"

Article Current Innovations and Practices To Address Microbial Contamination in Downstream Bioprocessing
Manufacturers’ efforts to avoid microbial contamination are today being complemented by developments from bioprocessing suppliers. A multifaceted, collaborative approach is the key to addressing t…

Article Challenging the cleanroom paradigm for biopharmaceutical manufacturing of bulk drug substances
Demonstration and quantification of bioburden reduction through efficacy studies for cleaning, sanitizing, and sterilization processes can eliminate the sources of microbial contamination from the env…

Article Ensuring Viral Safety of Viral Vaccines and Vectors
EMA, Guideline on Quality, Non-Clinical and Clinical Aspects Microbial Contamination of Gene Therapy Medicinal Products(London, May 2015). 17. EMA, Guideline on the Use of Bovine Serum in the Ma…

Article Bioburden Control in the Biopharmaceutical Industry
Thus, the safety of the biological preparation is a major consideration, and the assurance that the finished product will be protected from microbial contamination is an integral part of product safet…

Article Aseptic Processing: Keeping it Safe
Protecting operators Protecting drug product from microbial contamination is a key concern when making biologics, which is why aseptic filling typically occurs in a positive pressure isolator. In …

Article Real Time Continuous Microbiological Monitoring
Various regulatory agencies expect faster and more complete microbial contamination control. LIF is one of the solutions that both satisfies regulatory requirements and helps pharmaceutical companies …

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 Selecting a Comprehensive Bioburden Reduction Plan
Process maps and risk assessments are among the valuable tools operators can apply to reduce the risk of microbial contamination. By Randi Hernandez There are multiple variables to consider …

Article Antibody Production in Microbial Hosts
The authors review the status of expression of antibodies in microbial hosts and present the recent advances in the production of aglycosylated antibodies in bacteria. By Anurag S. Rathore, Jyot…

Article Regulatory Challenges in the QbD Paradigm
…ng, and evaluate process analytical technology and in-line or at-line sensors for early detection of microbial contamination. There is even the possibility of real-time release through the implementa…

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