LABORATORY QUALITY AND COMPLIANCE PRACTICES FOR GLOBAL REGULATORY CMC ANALYTICAL STUDIES FOR BIOTECHNOLOGY/BIOSIMILAR PRODUCTS
June 17, 2019 | (10:30AM)
USA (United States of America)
During the course of product development, and in the support of commercialized products, there are numerous biotech CMC studies conducted in non-GLP/non-GMP analytical laboratories (R&D labs). While it is true that these R&D labs are not required to follow GxP regulatory compliance statutes, much of the data they generate are used to support critical decisions on the process and the product. With the advent of biosimilar products, the role of R&D labs in product development has expanded to include extensive analytical comparability assessment of originator vs biosimilar product candidate.