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Abstract - To registrate a drug, a developer should submit chemistry, manufacturing and controls(CMC) document to KFDA. This document provides guidance on the content and format of the chemistry, manufacturing, and controls(CMC) for therapeutic recombinant DNA-derived products and monoclonal antibody products for in vivo use. The submission document on CMC of biotechnological product follows generally Provision for specifications and test procedures of drugs . This guideline is aimed to provide the distinct items of submission document on chemistry, manufacturing and controls(CMC) of biotechnological recombinant products, and the special consideration on the quality, safety and efficacy of monoclonal antibody of products.
This guideline informs physicochemical characterization of reference standard, manufacture,
method of manufacture, process control, reference standards, specification/analytical method,
stability to anyone who intends to develop therapeutic recombinant DNA-derived products and
monoclonal antibody products.