Axicabtagene Ciloleucel Infusion Suppliers & Bulk Manufacturers
Available Forms: IV Infusion
Available Strengths: Single infusion treatment approved for relapsed/refractory large B-cell lymphoma, with dosing based on patient weight
Reference Brands: Yescarta (US & EU)
Category: Cell & Gene Therapies
Axicabtagene ciloleucel is a CAR T-cell therapy that reprograms a patient’s T cells to target CD19-positive cancer cells. It provides rapid, targeted destruction of lymphoma cells, offering durable remissions, improved survival, and quality of life for patients with relapsed or refractory large B-cell lymphoma when administered in specialized centers. Axicabtagene Ciloleucel Infusion is available in IV Infusion and strengths such as Single infusion treatment approved for relapsed/refractory large B-cell lymphoma, with dosing based on patient weight. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Axicabtagene Ciloleucel Infusion is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.
| Technical Specifications & Supply Details | |
|---|---|
| Lead Time | 7 to 60 days (depending on batch size & schedule) |
| MOQ | As per manufacturer’s batch size |
| COA | Available with every batch |
| Regulatory Dossier / DMF | Available upon request |
| Export Documentation | FSC, COA, Manufacturing License, Product Permission |
| Standards | IP, BP, USP |
| Certifications | WHO-GMP, EU-GMP, USFDA (as applicable) |
Axicabtagene Ciloleucel Infusion can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.
Product Description:
Axicabtagene ciloleucel (Yescarta) is regulated in the EU and US, supported by dossiers demonstrating safety, efficacy, and manufacturing quality compliant with GMP and MDR standards. In the US, FDA approval involves extensive clinical validation and safety assessments. In the EU, CE marking certifies conformity with MDR regulations. These CAR T-cell therapies undergo validation, stability testing, and audits, with detailed documentation including clinical trial data, safety profiles, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to innovative, life-saving immunotherapies supporting advanced cancer treatments worldwide.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
Axicabtagene Ciloleucel is used for the treatment of certain types of large B-cell lymphomas that have not responded to previous therapies or have relapsed after at least two lines of systemic treatment. It is a type of CAR T-cell therapy, where a patient’s own T cells are genetically modified to recognize and destroy cancer cells. This treatment offers a potentially curative option for patients with aggressive, treatment-resistant lymphomas.
Axicabtagene Ciloleucel is made from a patient’s own white blood cells (autologous T cells) that are collected and genetically engineered to express a chimeric antigen receptor (CAR) targeting the CD19 antigen found on B-cell malignancies. The modified cells are then multiplied and infused back into the patient to attack and kill the cancer cells.
The trade name of Axicabtagene Ciloleucel is Yescarta®.
The brand name of Axicabtagene Ciloleucel is Yescarta.
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