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2022 | January / February 2022

Ultra-Potent pharmaceuticals: Verifying containment

by cyb2025
M. Axon, R. Sussman, P. J. Marshall
airborne concentration
anti-body drug conjugate (ADC)
containment verification
HPAPIs
limit of quantification
occupational exposure limit
Ultra potent pharmaceuticals

MARTIN AXON1, ROBERT SUSSMAN2, PETER J MARSHALL3
1. SafeBridge Regulatory & Life Sciences Group, Bury St. Edmunds, Suffolk, United Kingdom
2. SafeBridge Regulatory & Life Sciences Group, New York, USA
3. Cheshire, United Kingdom

ABSTRACT

The pharmaceutical sector, uniquely carries out extensive testing of their products on human subjects. This testing provides data that allows toxicologists to develop safe limits for occupational exposure. However, ultra-high potent pharmaceuticals, with exposure limits below 10 ng/m3 provide challenges by pushing the containment technology and the verification of this technology to the limits of what is achievable.

TOXICOLOGY OF ULTRA POTENT PHARMACEUTICALS
Over the past twenty or so years, it has been a recurring theme within the pharmaceutical industry that active pharmaceutical ingredients (APIs) are becoming more and more potent and toxic. The potency of these APIs is generally indicated by the occupational exposure limit (OEL) which is defined as the airborne concentration of a chemical substance that a worker can be safely exposed to for a 40-hour work week, over a working lifetime. The methodology used in deriving these values for APIs was initially published in 1988 by Sargent and Kirk (1), and has been repeatedly refined over the years, but the basic premise remains the same:

ABOUT THE AUTHOR

Martin W. Axon, CFFOH, CMIOSH is Senior Principal Occupational Hygienist for SafeBridge Europe with degrees in Industrial Chemistry and Environmental Pollution Science. He spent the majority of his career working in the pharmaceutical industry. During mid-career, Martin was a Course Director for a postgraduate program in Occupational Hygiene, Health and Safety, at London South Bank University.

Robert G. Sussman, Ph.D., DABT is one of the Managing Directors of SafeBridge Regulatory & Life Sciences Group, he has over 30 years’ experience in the pharmaceutical industry as a toxicologist performing risk assessments. He is certified by the American Board of Toxicology and holds a Ph.D. from New York University. Prior to working at SafeBridge, Dr. Sussman served as a Director at Warner Lambert and Pfizer.

Peter J Marshall Previously Associate Engineering Director, AstraZeneca Global Engineering and Real Estate, Macclesfield, Cheshire, UK.
BScEng Biochemical Engineer (UCL), worked for ICI/Zeneca/AstraZeneca for 36 years, 27 years working with high hazard chemicals and APIs.
Responsibilities included Company Global Subject Matter Expert for containment systems and Project Technical Manager/Engineering Lead for multiple international OSD developments, responsible for ensuring appropriate technology is procured and installed to meet client requirements.

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