Search results for " microbial"
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
It minimizes the risk of microbial growth, increases product stability with extended shelf life, eliminates agitation and foaming during transportation, and increases flexibility during manufacturing …
Article
Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
…nology
Continuous Processing for the Production of Biopharmaceuticals
Antibody Production in Microbial Hosts
Single-use Technologies in Downstream Process Intensification
A Risk-Based…
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Modeling Bioreactor Performance
“At the end of the day, cell-culture or microbial bioreactor runs evaluating growth, productivity, and product quality will confirm if a model is predictive,” Fenge states. Effective models can, howev…
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Managing Biomanufacturing Capacity Expectations
According to numbers from the 2016 BioPlan report (1), approximately 59% of respondents used at least some outsourced capacity for mammalian cell culture, 55% used outsourcing for microbial fermentati…
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Will the facility be manufacturing monoclonal antibodies, recombinant proteins, vaccines, antibody-drug conjugates, or fragment antibodies? Also, will the products be mammalian cell-derived or microbi…
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Biopharma in 2015: A Year for Approvals and Innovations
In 2015, one could also see how single-use technologies entered microbial processes to a larger extent. A paper on process economic comparison between fermentation in single-use versus stainless steel…
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Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
By Leonard P. Freedman, Mark C. Gibson, Richard M. Neve
Irreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays and increased costs of …
Article
Best Practices in Qualification of Single-Use Systems
Vinci and S Parekh, Handbook of Industrial Cell Culture: Mammalian, Microbial and Plant Cells (Humana Press, 2003).
13. P. Culter, Protein Purification Protocols, Second Edition (Humana Press, 200…
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Fluid Handling in Biopharma Facilities
For example, the film from which a biocontainer is manufactured-- just one component of a single-use system--needs to serve as a barrier to microbial ingress for the duration of the storage period. At…
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Cleaning of Dedicated Equipment: Why Validation is Needed
Finished surfaces should be smooth and properly polished, and equipment should be appropriately designed and assembled in a way that facilitates cleaning and prevents microbial growth (i.e., no dead l…