Biologics Production: Impact of Bioburden Contaminations of Non-Sterile Process Intermediates on Patient Safety and Product Quality

摘要

The term “Biologics” is used for a class of therapeutics that are produced by recombinant DNA technology and generally fall into three major categories: (i) therapeutic proteins, (ii) monoclonal antibodies (mAbs), and (iii) antibody-drug conjugates.