Case Study

A High Volume Process For Highly Potent (HP) Active Pharmaceutical Ingredients (APIs)

Source: Alkermes Pharma Ireland Limited

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 require 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 program, 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.

Ensuring these steps were in place was particularly important due to the fact that the Alkermes Athlone site is a multiproduct facility. Concern relating to crosscontamination with other products being manufactured had to be considered.