Therapeutic agents that lead to cell death upon administration are known as cytotoxic. Typically cytotoxic compounds are developed as oncology drugs, utilizing some mechanism where the drug is selective for tumor cells over normal cells.
Formulation of cytotoxic drugs and manufacturing of cytotoxic clinical supplies is a growing segment of the CRO/CMO industry; one whose needs are not being fully met by the outsourcing industry, especially at the early development stages. Formulation development and manufacturing requires a completely separate equipment set, GMP clean room space with additional isolation protection to prevent exposing personnel to dangerous levels of the drugs, and formulators and manufacturing operators trained in the specialized procedures for working with such compounds. Formex has over 50 man-years combined experience in the formulation and manufacture of cytotoxic dosage forms, and state of the art facilities for cytotoxic dosage form development and manufacturing.