Guidelines on the quality, safety and efficacy of biotherapeutic protein products prepared by recombinant DNA technology, Annex 4, TRS No 987

Overview

These Guidelines are intended to provide guidance to national regulatory authorities (NRAs) and manufacturers on the quality, safety and efficacy of biotherapeutic protein products prepared by recombinant deoxyribonucleic acid technology (rDNA-derived biotherapeutics) and intended for use in humans. The Guidelines are based on experience gained over three decades in this technically demanding field and replace Guidelines for assuring the quality of pharmaceutical and biological products prepared by recombinant DNA technology.

Part A of this annex sets out updated guidelines for the manufacture and quality control of rDNA-derived biotherapeutics, including consideration of the effects of manufacturing changes and of devices used in the delivery of the product and in its stability.

Part B is new and provides guidelines on nonclinical evaluation.

Part C, also new, provides guidance on clinical evaluation. 

Full version of the WHO Technical Report Series N° 987