To meet the current expectation of the Health Authorities (HAs), which varies from country to country, companies developing and commercializing biopharmaceutical products should set up a reference standard (RS) program and carefully plan a change control strategy for post approval changes.
Reference standards are developed as part of the analytical control strategy. Due to the nature of biopharmaceutical products (amongst other, structurally complex, heterogeneous mixtures, inherent batch-to-batch variability, sensitive to manufacturing changes), a well characterized reference standard is essential to ensure consistency between different batches of Investigational Medicinal Product. Also the use of a reference standard will ensure the comparability of the product to be marketed with that used in clinical studies and provide a link between process development and commercial manufacturing. Reference standards can help to provide solutions that support discovery, regulatory compliance, and process efficiency.
