For the previous blog in this series, raw material testing programs were outlined, and common considerations for Contract Development and Manufacturing Organizations (CDMO) were discussed. In this section, the focus will be a specific example and highlight some of the thought processes behind raw material program development. Captisol®, a common formulation excipient for injectables, will serve as said example.
Anyone with experience in the pharmaceutical industry knows that the APIs in drug products are tested rigorously for safety and efficacy before reaching the market. Before any raw material can be used for manufacturing, it must meet the requirements outlined in CFR chapter 211.84. Even minor issues with the API or a raw material could compromise the product’s integrity, leading to patient harm or expensive corrective actions such as recalls. Companies that perform drug product manufacturing and raw material testing take this responsibility seriously.