Search results for "fermentation" in Articles / App Notes
Article
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…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…
Article
A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
Bioprocessing equipment and materials, as well as technical discussions about process development, were in prominent positions at the INTERPHEX 2016 trade show, held in New York in late April. Rita …
Article
Tools for Continuous Bioprocessing Development
In addition to optical pH and DO sensors, the system combines miniaturized stirred tanks with a pipetting robot and automated feed pumps, greatly improving automation of the fermentation process. By u…
Article
Selecting a Comprehensive Bioburden Reduction Plan
If components or equipment are different for processes, such as microbial fermentation and mammalian culture, a separate risk analysis is performed for each process.
Personnel Training
BioPhar…
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
This article discusses cleaning validation of equipment dedicated to the production of a single API.
By Cristina Baccarelli, Paola Bernard, Teresa Cortellino, Oscar Cruciani, Rita Pacello, Chi…
Article
Ensuring the Quality of Biologicals
Biologicals are those products derived from biological sources such as tissues and cell extracts, fermentation using micro-organisms, plasma, plants, or those produced by recombinant DNA technology. T…
Article
Re-use of Protein A Resin: Fouling and Economics
In a typical platform process for production of mAb therapeutics, approximately 80% of the total process costs are for the steps following fermentation, with up to 60% of the downstream costs coming f…
Article
Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 4
Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …
Article
Quality by Design and Extractable and Leachable Testing
Impact on cell culture might also be important, particularly for single-use fermentation bags, for example, and USP Biological Evaluation, In Vitro (3) would be a reasonable minimal CQA for which to …