The biotechnology industry is undergoing a paradigm shift in the properties of the manufactured drug product. As therapeutic protein formulations change from agonist to antagonist methods of action, the concentration of proteins in each dose increased by orders of magnitude, and with it, the challenge of producing and inspecting the product. Current inspection technologies meet the requirements...

The U.S. Food and Drug Administration (FDA), through the Center for Biologics Evaluation and Research (CBER)/Center for Drug Evaluation and Research (CDER), has long identified that the development of biopharmaceutical products is becoming increasingly challenging, and is inefficient and costly. The agency has also commented that superior product-development sciences are needed to address the c...

How the Biopharmaceutical Industry Uses Molecular Imaging O ver the past decade, biomarkers have been recognized as a critical element needed to improve predictability and efficiency in the process of developing more effective, more affordable, and safer therapeutics for patients. Biomarkers can provide information critical to both internal decision making (e.g., establish presence of target, e...

C O M P U T E R 0 0 1 8 9 1 6 2 / 1 7 / $ 3 3 . 0 0 © 2 0 1 7 I E E E P U B L I S H E D B Y T H E I E E E C O M P U T E R S O C I E T Y S E P T E M B E R 2 0 1 7 83 Bioprocessing—a technique that produces biological material, such as genetically engineered microbial strains and commercially useful chemicals—is big business in the US and growing quickly around the world. An increasing number of ...