11.30.22 -- Key Components For Early Phase Trials

Intravenous (IV) drug administration has expanded as protein formulations have become increasingly complicated, interacting with the body faster and targeting therapeutic areas more precisely. It is imperative that sponsors understand the manufacturing time and means to analyze their IV products, as well as the regulator obligations relevant to their study.

To remove the risk of bias, drug substances, finished drug products, delivery apparatus, and kits must be visually indistinguishable from placebo units — including their respective labels. The content and creation of these labels is tightly regulated and benefits from the guidance of an experienced partner.

Compendial monograph (pharmacopeial) testing applied to pharmaceutical raw materials and finished drug products is a critical element of drug development. Discerning mandatory testing from supplemental testing for early-stage injectable or IV-infusion therapies streamlines CoA creation and promotes regulatory compliance.

A CDMO must know when to acquire new and emerging technologies, increase their overall instrument capacity, and continually maintain their existing validated instrumentation. The CDMO’s goal is to ensure that the client’s samples meet all testing requirements and specifications for stability over its projected lifetime.