Recombinant DNA: BIO Comments on WHO Guidelines on the Quality, Safety, and Efficacy of Biological Medicinal Products Prepared by Recombinant DNA Technology

The Biotechnology Industry Organization (BIO) appreciates the opportunity to comment on the “WHO Guidelines on the Quality, Safety, and Efficacy of Biological Medicinal Products Prepared by Recombinant DNA Technology.”  BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment. 

BIO is generally supportive of the World Health Organization (WHO) Draft Guidelines and has limited the scope of specific comments to the Nonclinical Evaluation section (Part B).  BIO believes that there are several topics in Part B for which additional clarification is warranted, including aspects of the current language that could result in additional animal use beyond that currently specified in International Conference on Harmonization (ICH) guidance or that is standard practice in biological medicinal product development.