OEL Fastrac Catalog

Maytansine and its derivatives (named as maytansinoids in general) are members of the ansamycins superfamily and contain 19-member macrocyclic lactams attached to a chlorinated benzene. Maytansine was originally isolated from the Ethiopian shrub Maytenus ovatus and exerts extremely high antimitotic potency. Maytansinoids are microtubule-targeting agents that share the same binding site with vinca and function by depolymerizing microtubules and arresting cells in the mitosis stage. Synthetic maytansine derivatives have been synthesized that possess 100-fold to 1000-fold increases in potency over drug maytansinoids (DMs) while also including modifications to enable conjugation to an antibody (antibody-drug conjugates (ADCs)). The form of ADC significantly increases the therapeutic window of maytansinoids compared to the free drugs, enabling the usage of an otherwise highly toxic drug in cancer treatments.

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.

Why do you need this OEL Fastrac monograph?

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:

• The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
• A listing of all cited references utilized in the derivation of the OEL and ADE
• An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

• Fully documented. Over 20 pages in length, with calculations and cited references.
• Save time! Unsurpassed delivery with instant download.
• Save money. Similar documents cost 5-12 times as much.
• Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Maytansine, just click the ADD TO CART button.

HBEL

If you're wondering about HBEL, we have something for you.