Monomethyl Auristatin E (MMAE) API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

Available Strengths: Supplied to an in-house or pharmacopoeial specification

Reference Brands: Adcetris, Padcev, Polivy, Tivdak

Category: Active Pharmaceutical Ingredient

Monomethyl auristatin E (MMAE) is a highly potent synthetic antimitotic used as the payload in several antibody-drug conjugates. It is sourced by ADC developers, CDMOs and research teams.

Product Description:

MMAE is a synthetic analogue of the marine natural product dolastatin 10 that blocks tubulin polymerisation and stops cell division. It is far too toxic to give on its own, so it is attached to monoclonal antibodies through a cleavable valine-citrulline linker (the vedotin linker-payload) and released inside target cancer cells. It is the payload in approved conjugates including brentuximab vedotin, enfortumab vedotin, polatuzumab vedotin and tisotumab vedotin, used in certain lymphomas, urothelial cancer and cervical cancer (reference brands: Adcetris, Padcev, Polivy, Tivdak).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 3 active Type II API DMFs for this molecule. Few filings usually means few qualified sources, so early contact with suppliers pays off. For Europe, ask whether the supplier holds a CEP or an EU ASMF and, for imports into the EU, a written confirmation.

Generic or biosimilar entry. United States: No confirmed date. European Union: No confirmed date.

Handling and quality points

MMAE is among the most potent compounds handled in pharmaceutical manufacturing and needs dedicated high-containment facilities with isolators, validated cleaning and strict occupational exposure controls. Buyers should confirm stereochemical purity (the molecule has several chiral centres), related auristatin impurities and residual solvents, as these carry through into the conjugate. Shipping and receipt need planning too: sealed primary and secondary containment, hazard labelling, and cold, dry storage in line with the supplier's stability data.

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Brand names are trademarks of their respective owners and identify the reference medicine only. Information is general and was checked in October 2026; confirm specifications and filings with the supplier before purchase.