Search results for "extractables"
Article
Speed and Flexibility Are Dual Goals for Biopharma Operations
To assist the adoption of single-use systems, industry organizations, such as the BioPhorum Operations Group and Bio-Process Systems Alliance, are addressing concerns about extractables and leachables…
Article
Efficient purification of meningococcal polysaccharides in a two-step chromatography workflow
This application note demonstrates the purification of meningococcal capsular polysaccharides using chromatography. The described process constitutes a viable alternative to the traditional proce…
Article
Efficient Purification of Pneumococcal Polysaccharides in a Chromatography Workflow
This application note demonstrates the purification of pneumococcal capsular polysaccharides using chromatography. The described process constitutes a viable alternative to the traditional process f…
Article
A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
Testing of plastic components for extractables and leachables, as well as performance and consistency from multiple suppliers, was a popular topic. The need for harmonized standards was emphasized, bu…
Article
Continuous Processing for the Production of Biopharmaceuticals
The authors review the technologies that may help bioprocessing become a truly continuous operation and present case studies that could contribute to the integration of upstream and downstream platf…
Article
Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
The necessity to detach cells from a culture substrate during cell harvesting remains one of the most challenging steps in a cell-culture process.
By Marcos Simon, Juan J. Giner-Casares
Cell…
Article
Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
Use of a subspace model is a viable method to characterize process space variables and optimize process performance.
By Colin Jaques, Daniela Lega
Over the past decade, two improved capabili…
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
Using Single-Use Technologies in Downstream Processing
Challenges of SUS in Downstream Processing
BioPharm: What specific challenges do manufacturers face when using single-use systems in downstream processing?
Mehta: Extractables and leachables a…
Article
Biopharma Advances Demand Specialized Expertise
For example, changes in formulations may cause different leachable profiles requiring increasing emphasis on extractables/leachables techniques (i.e., high-resolution MS) to support characterization o…