Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics.

ABSTRACT: In this review, we focus on providing basics and examples for each component of the protein therapeutic specifications to interested pharmacists and biopharmaceutical scientists with a goal to strengthen understanding in regulatory science and compliance. Pharmaceutical specifications comprise a list of important quality attributes for testing, references to use for test procedures, and appropriate acceptance criteria for the tests, and they are set up to ensure that when a drug product is administered to a patient, its intended therapeutic benefits and safety can be rendered appropriately. Conformance of drug substance or drug product to the specifications is achieved by testing an article according to the listed tests and analytical methods and obtaining test results that meet the accept

SUBMITTER: Limpikirati PK 

PROVIDER: S-EPMC11259812 | biostudies-literature | 2024 Jun

REPOSITORIES: biostudies-literature