The Critical Approach to the Design of a HPAPI Suite in a Multi-use Facility | CPhI North America

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The Critical Approach to the Design of a HPAPI Suite in a Multi-use Facility

Adam Kujath (Global Senior Director, Manufacturing Science and Technology, Alcami Corporation)

Location: E353c

Date: Wednesday, May 1

Time: 3:00pm - 3:45pm

Track: Drug Manufacturing

Vault Recording: TBD

The Highly Potent API (HPAPI) market is expected to grow more than 9 percent annually, exceeding $6 billion by 2020, thanks to the demand of highly targeted new drugs with higher efficacy at lower doses. These compounds can be small molecule APIs or the cytotoxic agent of an antibody drug conjugate (ADC). Due to the considerable risk to human health these compounds have during manufacturing, a comprehensive system of controls and containment is needed to ensure the safe handling of HPAPIs. The price of this investment has driven an increasing cross-section of the market to outsource their manufacture. However, it is not merely a question of having the physical assets for high containment; outsourcing of a specialized and potentially challenging piece of the supply chain requires partnership and collaboration between the contract development and manufacturing organization (CDMO) and sponsor. Several factors will dictate the performance of a CDMO when handling HPAPIs. A critical approach to risk mitigation of the entire process stream from receipt, development, manufacture, testing, and shipment is necessary. This presentation will discuss Alcami’s approach to designing a state‑of‑the‑art HPAPI suite, validation of containment procedures, and mitigation of risk to personnel and products in a multi-use facility, including a case study of a complex process implementation. Ultimately, success relies upon the equipment, experienced personnel, and a right‐first‐time ethos.

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