Highly potent technical transfer and commercial manufacturing
Alkermes’ successful approach to commercial-scale final dosage manufacture of drug product containing highly potent API
With more than 40 years in the service business, Alkermes Contract Pharma Services, as part of Alkermes plc, has proven expertise in drug product development, process design/improvements, technical transfer and commercial scale cGMP manufacturing of oral and injectable dosage forms, including the handling of highly potent drug substances.
This case study demonstrates how a commercial manufacturing partnership between Alkermes Contract Pharma Services (Alkermes) and a large pharmaceutical company resulted in the establishment of a high volume process for Highly Potent (HP) Active Pharmaceutical Ingredients (APIs).
The challenge
The manufacture of a Highly Potent Active Pharmaceutical Ingredient (HPAPI) compound can present many challenges due to the complex handling required for toxic substances. The successful and safe manufacture of HPAPIs requires the availability of a highly skilled team of staff with the right experience, the proper evaluation and training procedures being in place and the use of state-of-the-art facilities.
When taking on a HPAPI for final stage manufacture, it was important to follow a systematic approach to handle potent drugs safely. Other essential elements included the following: defined standard operating procedures, developing and managing a staff training programme, using tools to evaluate and measure exposure, designing and developing containment and controls, developing systems to verify effectiveness and finally determining and assessing the environmental impact of the active substance and associated manufacturing.