Search results for " microbial"
Article
Antibody Production in Microbial Hosts
However, clinical success of mAbs has tremendously increased their demand, and this in turn has fueled interest in other cost-effective alternative production systems such as microbial hosts. Further,…
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…
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Real Time Continuous Microbiological Monitoring
Traditional microbial monitoring within an EM program does not provide an exact quantity and quality of the microorganisms present in the manufacturing area. Numerous studies have shown that there is …
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Bioburden Control in the Biopharmaceutical Industry
Moreover, determination and identification of the nature and relative densities of microbial populations through trending analysis are essential for the appropriate selection of pre-filters rating and…
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Fermentation for the Future
Reinisch also notes that media costs for microbial fermentation are lower, although media costs for cell culture have been declining. Drivers of new technology development in microbial fermentation ar…
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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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The Outlook for CMO Outsourcing in 2019
… least some of their mammalian projects/products; 43% reported no (57% reported some) outsourcing of microbial work. The percent not outsourcing of any mammalian or microbial work has generally decre…
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Microbiological Testing: Time is of the Essence
Challener
Effective microbiological testing during biopharmaceutical drug development and manufacturing is crucial for ensuring sterility, determining antimicrobial effectiveness, detecting microbi…
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Aseptic Processing: Keeping it Safe
Compounding, if not carried out properly, can also introduce microbial loads. Normally, these would be filtered out, but can [still] result in high prefiltration bioburden levels.”
Future GMP init…
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Defining Risk Assessment of Aseptic Processes
It is often difficult to determine where a potential microbial ingress is coming from. This is why so much attention is given to monitoring personnel, equipment, air quality, etc., for microbial organ…