Search results for " preparative"

Article Transformative Medicines Challenge FDA and Manufacturers
Transformative Medicines Challenge FDA and Manufacturers New gene therapies and combination products require innovative regulatory approaches. By Jill Wechsler …

Article Start With the End in Mind: GMP Tech Transfer
How can you be one step ahead in process development and prepare for future GMP work? Hear what tech transfer experts have to say about this important issue in this blog. And, learn how to apply …

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. …

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 Bioburden Control in the Biopharmaceutical Industry
Protecting against microbiological contamination over the whole manufacturing process grows increasingly important. By Mostafa Eissa The biopharmaceutical industry has witn…

Article Managing Residual Impurities During Downstream Processing
Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures. By Cynthia A. Challener Manufacture of protein and other biologic drug substances via …

Article High Throughput Protein Purification at a Glance
Within the Human Protein Atlas project, scientists are using ÄKTA systems to purify up to 180 protein samples per week. The project uses antibodies to study the localization of proteins in huma…

Article Ensuring Sterility in Small-Scale Production
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses how to ensure sterility when manufacturing small-scale parenteral batches. By Susan J. Schniepp Q. I am a …

Article Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) u…

Poster Validation of the Production of Influenza Virus
This application note describes the validation of the single-use ReadyToProcess WAVE 25 rocking bioreactor system in production of influenza virus from Vero cells in microcarrier-based cultures. A 2…

Previous PageNext Page