Published: October 2013
The ISPE Guide: Biopharmaceutical Process Development and Manufacturing focuses on the development and the process approaches and practices involved in providing cost effective, regulated manufacturing of biopharmaceutical products in a timely manner that meet their intended use.
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.
The Guide is intended to be in alignment with ICH Q8 and ICH Q9 and applicable parts of ICH Q10 and ICH Q11, and associated international standards, regulations, and guidance documents. This Guide fundamentally addresses current US FDA GMPs. In addition, it includes commentary from other countries and regions regarding GMP compliance. US National Institutes of Health (NIH) and World Health Organization (WHO) requirements are referenced where applicable.
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.