Tag: <span>mabs</span>

Mammalian cell culture processes used in the production of monoclonal and recombinant proteins require orthogonal steps in the downstream process to clear virus. Virus filtration is a common, size exclusion-based method in these processes. Initially, tangential flow products were used, but as a result of new-generation virus filtration products, most operations are now constant-pressure, normal-flow operations that can be executed in a single shift operation. The virus filtration step toward the end of the downstream process is now yielding increased protein concentrations…

Biologics Production

This article reports the average titers and yields currently attained with commercially manufactured biopharmaceuticals expressed by microbial systems such as E. coli and yeasts. A recent BioProcessing Journal article comparably covered results from the first phase of this study concerning historical titers and yields attained for commercial-scale biopharmaceutical production using mammalian cells (e.g., CHO). As with this prior mammalian component, public domain data concerning titers and yields attained with microbially manufactured products were obtained using all available sources.

Biologics Production Bioreactor Scale-Up Mammalian Cell Culture Manufacturing Research

Implementation of “real-time” analytics (RTA) in processes for biologics is challenging from a technological and timeline perspective. Therefore, there need to be significant drivers from both a regulatory (quality) and a monetary standpoint to justify investment. Understanding how regulatory agencies define real-time analytics and the expectations for implementations (how and when) is a key component to rational decision-making, and dovetailing process improvement and facility design is important in the planning and development process…

Biologics Production Cell & Gene Therapy Cell Lines Mammalian Cell Culture Manufacturing Regulatory Viral Reference Materials Viral Vectors