December 02, 2016
On Friday December 2, 2016, Robert Sussman, Ph.D.,
DABT and Charlyn Reihman MPH, CIH, presented “Risk Assessment and Control of
Antibody-Drug Conjugates” at the Northeast Industrial Hygiene Conference in
Princeton, New Jersey.
Antibody Drug Conjugates (ADCs) represent a promising technology platform for the treatment of various cancers and other diseases. At the same time, they create challenges in the area of toxicology evaluation and hazard assessment, as well as in the development of proper handling procedures and controls. The presentation provided background information on ADCs, methodology for evaluating their occupational hazards, and examples of engineering controls, work practices, and practical handling solutions.
ADCs are composed of components including a monoclonal antibody (or other element that recognizes a specific receptor), linker, and drug/payload. Each component, as well as the conjugated molecule, must be evaluated to determine its inherent properties. The drug or payload component of the ADC is generally comprised of a highly potent and extremely toxic drug. Due to the unique and high toxicity of the drug, an occupational health category (band) is not sufficient and quantitative risk assessment is recommended in order to develop occupational exposure level (OEL), acceptable surface level (ASL), and Acceptable Daily Exposure (ADE).
Challenges associated with handling ADCs include determining controls for the various components which may involve different OELs. Developing controls for the ADC process requires creativity and collaboration due to processes that are not typical “pharma” processes and include many tasks that are similar to biological processes. It is important to work with the scientific and production staff to understand the process, provide training so that there is an understanding of the hazard, and then work together to develop appropriate controls. An additional challenge of ADCs is detecting the low concentrations of the drug and ADC in workplace air and on surfaces. However, SafeBridge’s industrial hygiene analytical laboratory has developed ELISA methodologies for detecting these moieties at sub-nanogram/filter concentrations.
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