Benralizumab Drug Substance Suppliers & Bulk Manufacturers
Available Forms: Drug substance (bulk)
Available Strengths: Supplied to an in-house or pharmacopoeial specification
Reference Brands: Fasenra
Category: Active Pharmaceutical Ingredient
Benralizumab is a humanised, afucosylated anti-IL-5 receptor alpha IgG1 antibody used in eosinophilic diseases. Its drug substance is sourced by biosimilar developers, CDMOs and R&D teams.
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Product Description:
Benralizumab is a humanised IgG1 kappa antibody that binds the alpha chain of the interleukin-5 receptor on eosinophils and basophils; because it lacks core fucose, it strongly recruits natural killer cells, which remove eosinophils by antibody-dependent cell-mediated cytotoxicity. In the US it is approved as add-on maintenance treatment of severe eosinophilic asthma in patients aged 6 and older, for adults with eosinophilic granulomatosis with polyangiitis, and for hypereosinophilic syndrome in patients aged 12 and older (reference brand: Fasenra).
Specification at a glance
| Traded form | Humanised, afucosylated IgG1 kappa monoclonal antibody produced in Chinese hamster ovary (CHO) cells |
|---|---|
| CAS number | 1044511-01-4 |
| Molecular weight | approx. 150 kDa |
| Pharmacopoeia | No product-specific pharmacopoeia monograph found; in Europe the Ph. Eur. general monograph on monoclonal antibodies for human use applies. Supplied to an in-house specification. |
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 (2028-2034). European Union: Patent expiry; entry not confirmed (2025 / 2028-2034).
Handling and quality points
The lack of core fucose is central to how benralizumab works, so any biosimilar drug substance must show a matching afucosylation level and ADCC activity, which usually depends on a glyco-engineered cell line. Buyers should review the cell line's origin and freedom to use it, as well as cell bank testing. Like other antibody solutions it needs a validated refrigerated or frozen cold chain, with data on aggregation and stability under shipping stress.
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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.
Benralizumab Drug Substance — third party manufacturing & bulk supply
Benralizumab Drug Substance is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:
Indicative minimum order quantity
Benralizumab Drug Substance is supplied as Drug substance (bulk) — a dosage form priced by order value, so the indicative MOQ is a minimum order value of USD 5,000 per product. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.
Manufacturers of Benralizumab Drug Substance listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.
Request a quote for Benralizumab Drug Substance →Usually answered within 48 hours, with matched manufacturers, indicative prices and document status.
Frequently Asked Questions
Buyers look for the GMP certificate, certificate of analysis and a comparability package covering glycan profile, afucosylation, ADCC and IL-5Rα binding against the reference product. Cell bank documentation, viral clearance data, process validation and stability results are also expected. As with other biologics, much of this goes into the marketing application itself, so agree data access terms early.
Removing core fucose from the antibody's Fc glycan greatly increases binding to the FcγRIIIa receptor on natural killer cells, which drives the eosinophil depletion the medicine relies on. A biosimilar must match this level closely, so ask how the supplier controls and measures afucosylation batch to batch.
Yes. PharmaTradz puts licensed manufacturers, CDMOs and biosimilar developers in touch with GMP-compliant antibody producers, with a document check before introductions. We keep buyer details private until both sides agree.
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