Brentuximab Vedotin Drug Substance Suppliers & Bulk Manufacturers

Available Forms: Drug substance (bulk)

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

Reference Brands: Adcetris

Category: Active Pharmaceutical Ingredient

Brentuximab vedotin is a CD30-directed antibody-drug conjugate. Its drug substance and intermediates are sought by biosimilar developers, ADC CDMOs and R&D teams.

Product Description:

Brentuximab vedotin is an antibody-drug conjugate in which a chimeric anti-CD30 antibody carries the microtubule-disrupting agent monomethyl auristatin E (MMAE) through a protease-cleavable linker, releasing it inside CD30-expressing cells. It is approved for classical Hodgkin lymphoma and for several CD30-positive T-cell lymphomas, including systemic and primary cutaneous anaplastic large cell lymphoma, in specified treatment settings (reference brand: Adcetris).

Specification at a glance

Regulatory files and timing

Biologic drug substance is usually supplied in bulk under a long-term supply agreement, or licensed together with the dossier, rather than bought as a one-off API order. Buyers typically ask for the drug substance comparability package, cell bank and process documentation, and the supplier's GMP status.

Generic or biosimilar entry. United States: Patent expiry; entry not confirmed (2026). European Union: Patent expiry; entry not confirmed (Oct 2027).

Handling and quality points

This is both a biologic and a high-potency product: the conjugate needs cold-chain storage and protection from freezing-thaw stress and agitation, while the MMAE linker-payload and the conjugation step need full high-potency containment. Key quality attributes include the drug-to-antibody ratio and its distribution, unconjugated antibody, free payload, aggregates and binding and cytotoxic potency. Expect the supply chain to involve separate sources for the antibody intermediate and the linker-payload.

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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.