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Approach to handling high potency APIs-An overview

corresponding

WILLIAM DUBAY1*, SAMUEL BARON2*, JENNIFER O’LEARY2
*Corresponding authors
1. SK pharmteco, USA
2. SK biotek, Ireland

Abstract

Manufacture of HPAPI 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 HPAPI using a risk-based approach and an appropriate banding system. The article also lists examples of controls that could be applied to ensure safe handling of materials, commensurate to their potency.


The global market for Highly Potent Chemical Intermediates and Active Pharmaceutical Ingredients (HPAPI) is fast-growing at an estimated 10% annual rate. This growth is compounded by the growth in the oncology market (1).

 

Manufacture of HPAPI presents unique challenges, in particular around material handling and containment strategy.

 

A robust safety management of HPAPIs is paramount. 

A company should have a safety program in place to classify and control the management of highly potent compounds, including HPAPI used on site. This program could utilize a risk-based approach to ensure appropriate controls are in place, commensurate to the hazardous nature of the chemical. It includes:

 

- A six-band Exposure Control Band (ECB) system is in place at SK pharmteco with chemical intermediate and API categorized to an appropriate standard band to guide handling and engineering requirements;

- Systematic chemical classification of all chemicals manufactured or handled on site based on safety data and chemical composition/structure of the material.


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