Case Study: A Successful Approach to Commercial Scale Final Dosage Manufacture of Drug Product Containing Highly Potent API

Overview:

Case Study: A Successful Approach to Commercial Scale Final Dosage Manufacture of Drug Product Containing Highly Potent API

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. In this case study learn 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). 

 

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