Search results for " microorganisms"
Article
Real Time Continuous Microbiological Monitoring
It is a common assumption that if fewer total particulates are present in a cleanroom, it is less likely that airborne microorganisms will be present. This is true only if human operators are the main…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
Studies are ongoing on sterilizing filtration, effects of terminal sterilization energies on classes of products, and methods for detection of elusive microorganisms in drug components and manufacturi…
Article
Bioburden Control in the Biopharmaceutical Industry
In addition, the growing list of super microorganisms that show broad-spectrum resistance to different classes of antimicrobials is becoming more common.
Up-to-date lists of product recalls due…
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
Microbial contamination of continuous cell cultures by a wide variety of microorganisms is also problematic in cell culture laboratories worldwide, particularly by mycoplasma. The latter can be diffic…
Article
Fermentation for the Future
Improving efficiency, value chain, quality, and protein complexity with advanced bioprocess development.
Jan 01, 2015
By Cynthia Challener, PhD
Microorganisms—bacteria and yeast—have b…
Article
Nurturing Knowledge from Disparate Data Streams
Because biologic drug substances are produced in cells or microorganisms, their structures and compositions can vary slightly from batch to batch, leading to inherent variability, according to Tiffani…
Article
Sanitization of ÄKTA™ pilot 600 Using Sodium Hydroxide
The results show excellent cleaning efficiency, with a log reduction factor of ≥ 6 for colony forming units (CFUs) of the test microorganisms. Sanitization of the SNAP-connectors using 1 M NaOH was al…
Article
Ensuring the Biological Integrity of Raw Materials
Ultraviolet disinfection is a powerful technique for neutralizing living microorganisms. Exposure to the UV light causes the formation of dimers between neighboring nucleic acids in the genome, which …
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
Cleaning validation studies, therefore, should demonstrate that storage conditions do not contribute to growth of microorganisms. Evaluations need to be performed on a case-by-case basis; a CHT might …