Analytical Instrumentation – Advancing And Maintaining A CDMO's Capabilities

By Ryan Memmer, Supervisor Quality Control, Singota Solutions

Contract Development and Manufacturing Organizations (CDMOs) in the pharmaceutical/biotech industry rely heavily on state-of-the-art instrumentation to bring their client’s products from drug development through drug manufacturing to the patient. An analytical chemist will use advanced, computer-controlled instrumentation to measure the safety and quality of these products, perform process and product development studies, and ensure their company complies with regulatory requirements.

To better serve their client’s needs as technology and the pharmaceutical industry advances, a CDMO must know when to acquire new and emerging technologies, increase their overall instrument capacity, and continually maintain their existing validated instrumentation.

A pharmaceutical company may rely on a CDMO to do all of the analytical testing for an active pharmaceutical ingredient, or a finished drug product, for which the CDMO is doing the formulation, manufacturing, filling, packaging, storage, and fulfillment. The CDMO’s goal is to ensure that the client’s drug is pure, potent, and stable over its projected shelf life.