By Ken Chomistek, Singota Solutions
Compendial monograph (pharmacopeial) testing applied to pharmaceutical raw materials and finished drug products is a critical element of drug development. A testing record is created in the form of a Certificate of Analysis (CoA) for manufacturing release and distribution. However, the testing required for a given product can be a source of consternation for biopharmaceutical sponsors and their partners.
Some tests/assays are mandatory, while others are supplemental, optional additions that can make a CoA more robust. Still other tests are product specific. For early-stage injectables or IV-infusion therapies — the focal point of this article — between 5 and 30 tests could appear on a CoA, though that number differs depending on applicable regulations where the therapy is to be manufactured and/or distributed.
A drug product formulation includes the active pharmaceutical ingredient (API) and, typically, salts, preservatives, and/or other buffers in the solution, an acid or base to adjust the formulation’s pH, and/or a surfactant (or co-surfactants working together). Each component of the formulation (raw material) requires its own CoA, as does the final drug product. Accordingly, some tests need not be repeated at the drug product level because their requirements have been satisfied at the raw material level.
Ultimately, sponsors are responsible for ensuring all necessary testing has been performed on their drug substance/drug product to satisfy a given regulator’s CoA requirements. However, a knowledgeable, well-established partner can help sponsors through the testing process, saving them time and expense.