Relevance of Raw, Starting and Ancillary Materials for Advanced Therapies

Advanced therapy safety and efficacy is critically dependent on the quality of the materials that enter the manufacturing process. The United States Pharmacopeia (USP), whose standards have protected pharmaceutical quality for over two hundred years, is continuing to develop reference standards, informational chapters, and compendial analytical methods to safeguard raw, starting and ancillary materials for Advanced Therapies. USP’s standards give best practice guidance to developers and manufacturers, simplify risk assessments, accelerate analytical development, and support raw material qualification and release. This presentation will describe existing standards and USP's recent development related to plasmid DNA and rapid microbial methods.