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Choosing a CMO for your Highly Potent Pharmaceutical – Looking beyond the isolator

KEVIN HAEHL, P.E.
Evonik Corporation, 299 Jefferson Road, Parsippany, NJ 07054, USA

Abstract

Kevin Haehl, Director of Global Business Development Advanced Technologies for Evonik Corporation, explains why choosing a successful manufacturing partner for highly potent pharmaceuticals requires an in-depth look at a contract manufacturing organisation’s policies, practices and people.


THE DECISION TO OUTSOURCE HIGHLY POTENT PHARMACEUTICAL MANUFACTURING

Advances in pharmacology have resulted in the creation of highly potent compounds for the treatment of disease. These compounds exhibit pharmacological effects at very low doses, but they often have undesired occupational health effects that are manifested at even lower levels. While these developments are providing great benefits for patients, the pharmaceutical manufacturing industry has had to respond by developing highly specialised equipment and practices to protect the safety of workers, the environment and the quality of the product.
From an industrial hygiene (IH) perspective, the occupational exposure limit (OEL) for airborne particles of a Highly Potent Active Pharmaceutical Ingredient (HPAPI) is typically less than 10 μg of the compound per m3 of air averaged over a day’s 8-hour work period. In some cases, the limit can be lower by several orders of magnitude. To put this level of containment in practical terms, if a typical single grain of table salt weighing 60 μg were crushed and evenly distributed in an empty 12 metre sea cargo container with an interior volum ...