White Paper

Key Criteria When Evaluating A High Potency Manufacturing Outsourcing Partner

Source: Alkermes Pharma Ireland Limited
Registration Support- New Drug Application

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?

Many companies are choosing to outsource the manufacture of their highly potent compounds for strategic and/or economic reasons. A provider of contract pharma services in high potent manufacturing, Alkermes Contract Pharma Services, outlines here some of the elements that should be considered by a Sponsor/Donor Pharmaceutical company when outsourcing secondary processing (i.e. dosage form transfer, scale-up and commercial manufacture) of a highly potent product.