Blinatumomab Drug Substance Suppliers & Bulk Manufacturers

Available Forms: Drug substance (bulk)

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

Reference Brands: Blincyto

Category: Active Pharmaceutical Ingredient

Blinatumomab drug substance is a CD19/CD3 bispecific T-cell engager used in B-cell acute lymphoblastic leukaemia. It is sought by biosimilar and biologics developers.

Product Description:

Blinatumomab is a bispecific T-cell engager: one end binds CD3 on T cells and the other binds CD19 on B cells, bringing them together so the T cell can kill the leukaemic cell. It is approved for CD19-positive B-cell precursor acute lymphoblastic leukaemia in remission with measurable residual disease, in relapsed or refractory disease, and in the consolidation phase for Philadelphia chromosome-negative disease, in adults and children (reference brand: Blincyto).

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 (Apr 2030). European Union: Patent expiry; entry not confirmed (Nov 2029).

Handling and quality points

Blinatumomab is a small single-chain protein given at very low doses, so potency assays and control of aggregates and fragments are central to any specification. Drug substance needs controlled cold-chain storage and shipping, supported by freeze-thaw and agitation studies. The reference product includes a stabiliser to stop the protein sticking to infusion bags and lines, which is worth discussing with formulation partners early.

Send an API enquiry All specialty APIs

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.