Search results for " microbial" in Articles / App Notes
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…
Article
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…
Article
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…
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Taking a “Development-by-Design” Approach to Cell Therapies
Have the end in mind
Such things as formulation issues, dosage potency, impurities, residuals, and microbial assurance need to be thought out clearly from the start, Hampson says, as well as indic…