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•Article: Handling Protocols - Key Consideration In HPAPI Market

By Trevor Calkins, Director of Process Development, SAFC

Over the past 10 years, the manufacture of highly potent active pharmaceutical ingredients (HPAPIs) has become increasingly attractive to contract manufacturers due to significant advances in clinical pharmacology and oncology research. In addition, with factors such as fewer FDA drug approvals, over-supply and stiff competition from Asia-Pacific producers putting pressure on profitability and margins in the ‘traditional' API sector, the rapidly growing HPAPI segment has an annual double digit growth rate and has become something of a ‘promised land' for CMOs. However, while the development and manufacture of HPAPIs present exciting prospects for the pharmaceutical sector, entry into this market brings significant challenges, primarily in terms of planning, proper equipment and facility design, personnel requirements and the implementation of the necessary procedures to safely handle the compounds. Knowledge gained through experience is, therefore, invaluable and robust systems must be employed throughout the HPAPI handling program, from initial project evaluation, through equipment cleaning, to waste disposal.

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•Article: Handling Protocols - Key Consideration In HPAPI Market