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Engineering Controls Within HPAPI Manufacturing

Source: AbbVie

By Olindo Lazzaro and Max Brescia

sterile cleanroom protective gear

As the demand in the global market for HPAPI drugs grows, so too is the expense of manufacturing HPAPIs due to the requirements for specialized facilities, additional PPE, medical surveillance for workers, pollution controls, and specialized housekeeping. As a result, more and more often the question pharmaceutical companies find themselves asking is, "Should we be searching for a CMO to manufacture our HPAPI?"

In this article, scientists from AbbVie Contract Manufacturing, a division of AbbVie, answer that question and discuss the strict regulations regarding the manufacture of HPAPIs and adherence to stringent guidelines to ensure that safety remains of paramount importance.