Ravtansine, also referred to as DM4, is a maytansine derivative that belongs to the group of tubulin inhibitors. It is too toxic to be used as a drug alone, but is being used, similarly to mertansine (DM1), as the cytotoxic component of antibody drug conjugates (ADC)s. At the time of writing this monograph, ravtansine ADCs have and are being evaluated in clinical trials focused on the treatment of a variety of cancers. Ravtansine binds to tubulin and disrupts microtubular dynamics causing cells to arrest in G2/M phase of the cell cycle leading to cell death by apoptosis. The mechanism of action of ravtansine, maytansine, and mertansine (DM1) are the same; however, unlike DM1, metabolism of ravtansine produces metabolites that diffuse across the cell wall and kill surrounding cells.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.
OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:
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Affygility Solutions’ OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.