Challenges and Opportunities in Highly Potent Active Pharmaceutical Ingredient (HPAPI) Manufacturing

Sponsored Content by Powder SystemsMay 15 2024Reviewed by Andrea Salazar Highly potent active pharmaceutical ingredients are at the forefront of pharmaceutical manufacturing. They are particularly common in targeted therapies and personalized medicines. This is primarily due to their potent therapeutic effects at low dosage forms.

Highly potent compounds were initially confined to oncology research areas as they demonstrated restricted applicability for drug products beyond cancer treatment due to their limited specificity. The situation has since changed, and novel drug delivery systems, such as antibody-drug conjugates , have paved the way to highly targeted therapies.

Planning well defined zones, limiting personnel movement, and using state-of-the-art containment technologies highlight the industry’s commitment to ensuring the safe handling of potent compounds in commercial manufacturing of new drug systems. However, outsourcing does not mean there is no risk. The main concern is selecting competent CMOs or CDMOs with demonstrated proficiency in safely handling highly potent compounds.

These challenges highlight the need for careful planning, clear contractual agreements, and the selection of a dependable outsourcing partner when considering outsourcing HPAPI manufacturing.

HPAPI Manufacturing

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