Highly Potent Technical Transfer and Commercial Manufacturing

Overview:

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 contained facilities.

This case study demonstrates how a commercial manufacturing partnership between a pharmaceutical contract manufacturer and a large pharmaceutical company resulted in the establishment of a high volume process for Highly Potent Active Pharmaceutical Ingredients.

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