Tag: <span>mabs</span>

Biopharmaceutical Manufacturing: Current Titers and Yields in Commercial-Scale Microbial Bioprocessing

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.

Read MoreBiopharmaceutical Manufacturing: Current Titers and Yields in Commercial-Scale Microbial Bioprocessing

Biologics Production Bioreactor Scale-Up Mammalian Cell Culture Manufacturing Research

bacteria biopharmaceutical manufacturing mabs microbial bioprocessing microbial expression monoclonal antibody titers and yields yeast

Regulatory and Monetary Drivers for Real-Time Analytics

Implementation of ā€œreal-timeā€ 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 processā€¦

Read MoreRegulatory and Monetary Drivers for Real-Time Analytics

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

at-line analytics biolgics design space biologics cpp critical process parameters design-of-experiments doe fda guidance fmea in-line analytics ind investigational new drug mabs monoclonal antibodies on-line analytics pat process analytical technology real-time analytics regulatory considerations rta