Low doses of highly potent active pharmaceutical ingredients (HPAPIs) treat cancer, autoimmune diseases, and other medical conditions, often with reduced side effects. Because these compounds can have a major cytotoxic effect in even tiny amounts, their safe handling is a challenge for personnel during manufacturing. Drug manufacturers must take precautions at every step of production.
Those safeguards can seem burdensome when flexibility to handle to handle different substances, formulations, batch sizes and production processes is critical to keeping a drug development project on track, on time, and on budget. Partnering with a contract development and manufacturing organization with expertise in safely handling HPAPIs can be a valued asset in the development process.