ABSTRACT
The Food and Drug Administration (FDA) established a regulatory approach for the approval of recombinant DNA-derived protein products, which was announced in the Federal Register. The FDA encourages the use of widely available state-of-the-art technology. The FDA provides detailed guidance for additional chemistry, manufacturing, and controls information that are relevant to assessing whether the proposed product and the reference product are highly similar. Physicochemical evaluation of the proposed product and the reference product should consider all relevant characteristics of the protein product. If a reference product exhibits multiple functional activities, the sponsors should perform a set of appropriate assays designed to evaluate the range of relevant activities for that product. The safety of the proposed product, as with any biological product, with regard to adventitious agents or endogenous viral contamination, should be ensured by screening critical raw materials and confirmation of robust virus removal and inactivation achieved by the manufacturing process.
