Search results for "regulatory"
Article
Handbook: Design of Experiments in Protein Production and Purification
Design of experiments (DoE) is a technique for planning experiments and analyzing the information obtained. The technique allows us to use a minimum number of experiments, in which we systematically v…
Article
Platform Technologies Improve Protein Expression
Improving yield has always been and will continue to be one of the key drivers for a technology platform to be successful, explains Havenga, although clearly agility, product quality, and regulatory a…
Article
Development of Purification for Challenging Fc-Fusion Proteins
Development of Purification for Challenging Fc-Fusion Proteins
This study outlines methods for an alternative protein-polishing process for challenging proteins.
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Poster
Repurposing Fed-Batch Media and Feeds for Highly Productive CHO Cell Perfusion Processes
The authors developed a method for identifying first-generation perfusion culture media based on existing fed-batch media and feeds. Here, they show that they can obtain culture media that successfull…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
The authors review how media components modulate the quality of monoclonal antibody products.
By Anurag Rathore, Rajinder Kaur, Dipankar Borgayari
Recombinant protein products have…
Article
Process Chromatography: Continuous Optimization
Improved resin chemistries and customized separation solutions are enabling more efficient separations.
By Cynthia A. Challener
Cell-culture and fermentation are high-…
Article
Automated In-Line Buffer Preparation from Ready-Made Stock Solutions in a mAb Process Step
Buffer preparation is both time-and space-consuming and can easily become a challenge in biomanufacturing. This application note describes a lean approach to buffer preparation by implementing in-li…
Article
Column Tips for Successful SEC-MALS
Do you identify molecules using MALS, maybe in combination with size exclusion chromatography (SEC)? We have gathered Column Tips for Successful SEC-MALS in a blog post. Tap into these column …
Article
Managing Risk in Biomanufacturing
We simply cannot avoid all risks and the stakes are high in the biopharmaceutical industry. With patients’ lives dependent on a continuous supply of high-quality drugs and vaccines, it is essential …
Poster
Strategies for optimized cell culture media: Effectively using design space to influence product quality
Effective biopharmaceutical production is achieved in part through target-specific, quality-optimized cell culture media. Balancing the many individual media components required to achieve high tite…