Guidance for Industry: Chemistry, Manufacturing, and Controls (CMC) Information-Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products for Veterinary Medicinal Use

摘要

Fermentation processes are frequently used to manufacture intermediates, drug substances, and related drug products for veterinary medicinal use. Traditionally, most manufactured fermentation products were extracted from the media or cell mass and either further purified or molecularly modified to create another entity. Today, a variety of products are manufactured from fermentation processes, including: Biomass products (i.e., drug and cell mass constitute the product); Competitive exclusion products (i.e., the product consists of one or more microorganisms intended to exclude harmful bacteria, such as Salmonella, from colonizing); Biotech products; and Bacteriophage products. Microbial systems can introduce manufacturing variability that can affect the purity and quality, and ultimately, the safety and effectiveness of a product, if not controlled. Even though fermentation is a common manufacturing practice, CVM currently provides no CMC guidance to pharmaceutical sponsors about fermentation-derived intermediates, drug substances, or related drug products.