SAMUEL BARON1, WILLIAM DUBAY2
1. Director of R&D SK biotek Ireland
2. Vice President Global Research and Development SK pharmteco

Abstract

Manufacture of HPAPIs presents unique challenges, in particular around material handling and containment strategy. This article provides an overview of principles to apply for a robust and safe handling of HPAPIs. The article also lists examples of where the use of a risk-based approach supported by data can lead to increased flexibility in manufacturing and R&D capabilities.

Through continuous improvement in the field of containment and risk management, ability to scale-up and manufacture highly potent chemical intermediates and APIs (HPAPIs) continues to improve in the pharmaceutical industry. A well-established safety management system for HPAPIs can lead to increased flexibility in manufacturing and R&D capabilities.

A robust safety management of HPAPIs is paramount. The safety approach program in place at SK pharmteco to classify and control highly potent compounds, including HPAPIs used on site, utilizes a risk-based approach to ensure appropriate controls are in place, commensurate to the hazardous nature of the chemical. Key aspects of a robust safety management approach include:

• A well-defined banding system for air concentration of substances across many band widths need to be handled. API portfolios at many pharmaceutical companies contain a significant portion of compounds with Occupational Exposure Limits (OEL) ≤ 100 µg/m3. In the SK pharmteco banding system, the OEL region ≤100 µg/m3 is split in 4 bands. Each band corresponds to a different level of containment controls req ...
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