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The Key to HPAPI Containment in a Multi-Product Facility

Drugs containing highly potent active pharmaceutical ingredients (HPAPIs) are becoming increasingly prevalent in the development pipeline due to their benefits in the treatment of various medical conditions, such as cancer and rare diseases. While providing significant benefit, developing and manufacturing these compounds pose several challenges and as a result, a growing number of HPAPI programs are outsourced to contract development and manufacturing organizations (CDMOs) that have the necessary facilities, equipment, and personnel to scale up manufacturing to commercial production, and can share critical infrastructure across multiple programs. This article explores the key factors pharmaceutical companies should consider when selecting a CDMO and evaluating its multi-product facility capable of handling HPAPIs to de-risk their programs and bring their products to patients safely.

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Understand how CDMOs and can effectively handle and manufacture HPAPI-containing products in a multi-product manufacturing facility

Learn the importance of integrating a robust NPI strategy to support program onboarding

Gain insight into implementing a risk-based management approach to control cross-contamination and protect other products in a multi-product site

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Why Catalent?

Catalyst + Talent

Catalent is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply over 70 billion doses of more than 7,000 products to over 1,000 customers annually. Catalent’s expert workforce exceeds 17,000, including more than 2,500 scientists and technicians. Headquartered in Somerset, New Jersey, the company generated $4 billion in revenue in its 2021 fiscal year. For more information, visit www.catalent.com.

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