| The list of biopharmaceuticals produced by recombinant DNA technology, transgenics and synthetic manufacture continues to grow to encompass therapeutic and diagnostic agents ranging from antibodies to vaccines. Regardless of the method of production, all these products present the biotechnology community with complex challenges in manufacture and, ultimately, analytical characterisation. Recognising the importance of this topic, a recent international conference was held on 'The Impact of Post-Translational and Chemical Modifications on Protein Therapeutics' (1). At this meeting of leading scientists from academia and industry, a keynote address was given by Dr Keith Weber, Deputy Director, Division of Monoclonal Antibodies, Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research (CBER), FDA. Dr Weber presented the current CBER perspective on post-translational and chemical modifications, emphasising above all that CBER's primary concerns are "safety, purity, potency and strength of bioproducts". |
