High Potency Product Manufacturing 

Key selection criteria when evaluating an outsourcing partner
Summary 

Approximately 25% of drugs in development worldwide are classified as highly potent, with this percentage expected to grow over the coming years. A compound is generally classed as highly potent if it has an occupational exposure limit (OEL) of ≤10μg/m3, a daily therapeutic dose of ≤10mg/day or if a 1 mg/kg/day dose produces serious toxicity in laboratory animals. While such highly potent compounds can have significant benefits in the treatment of certain medical conditions, they present substantial challenges to the pharmaceutical industry. 

These challenges include: can personnel and the environment involved in the manufacture of high potency products be protected; can adequacy of controls preventing contamination of other products by high potent materials be demonstrated; and can expectations of clients and/or regulators regarding separation or segregation of manufacturing activities be satisfied?