This Guide intends to present a universal roadmap for process development and manufacturing of biopharmaceuticals that provides practical, scientifically sound guidance that helps users incorporate good practice and insight in order to develop robust processes that produce safe and more cost effective biopharmaceuticals.
This Guide applies to the class of products that include protein therapeutics, monoclonal antibodies, and/or those cells or organisms that have been generated or modified by recombinant DNA/RNA, or other technologies to produce drug substance. It may also be applied to cell culture based vaccine products.
This Guide is intended to be used in the design, development, implementation, operation, quality control, and quality assurance of biopharmaceutical processes. This guidance should be useful to persons involved in these activities, including process development scientists and engineers;manufacturing, quality, and industry suppliers. This also includes regulatory personnel with a need to understand fundamental biopharmaceutical processes.