Description

Blinatumomab is a bispecific T-cell engager (BiTE) antibody construct designed for targeted immunotherapy. This precision-engineered biologic is of critical importance for its ability to redirect the body's own T-cells to recognize and eliminate specific cancer cells. It is primarily required by pharmaceutical manufacturers, advanced therapy medicinal product (ATMP) developers, and clinical research organizations focused on oncology. The compound, identified as CAS NO 853426-35-4, represents a significant advancement in the treatment of certain hematologic malignancies.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the active pharmaceutical ingredient in targeted cancer immunotherapies.
• Oncology Drug Development: Critical raw material for the research, formulation, and production of novel bispecific antibody therapies.
• Clinical Trial Material (CTM): Sourced for use in Phase I-III clinical trials investigating new treatment protocols for B-cell precursor acute lymphoblastic leukemia (B-ALL).
• Biosimilar & Biobetter Development: Reference standard and starting material for companies developing biosimilar or enhanced versions of existing blinatumomab therapies.
• Preclinical Research: Used in academic and institutional laboratories to study mechanisms of T-cell engagement, tumor cell lysis, and resistance pathways.
• Cell Therapy Combination Studies: Investigated in combination with CAR-T cell therapies and other immunomodulatory agents to improve therapeutic outcomes.

Basic Information

Product Name	Blinatumomab
CAS No.	853426-35-4
Molecular Formula	C2358H3664N648O698S18
Molecular Weight	~54.1 kDa
Synonyms	AMG 103; Anti-CD19 x Anti-CD3 Recombinant Bispecific Monoclonal Antibody; MT103; Bispecific T-cell Engager (BiTE) Antibody Construct CD19/CD3; Blincyto (Brand Name); Recombinant Blinatumomab; CD19xCD3 BITE; BITE Antibody Blinatumomab
EINECS	Contact for details

Quality Control

Our Blinatumomab is manufactured and controlled under a strict quality management system. Each batch is subjected to a comprehensive battery of analytical tests to ensure identity, purity, potency, and safety, aligning with ICH Q6B guidelines for biotechnological products. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting critical quality attributes such as purity by SEC-HPLC, biological activity in cell-based assays, and absence of host cell proteins and DNA.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store lyophilized material at -20°C or below. Reconstituted or liquid formulations typically require storage at 2-8°C. This product is hygroscopic (moisture-sensitive) and must be handled under controlled, low-humidity conditions to maintain stability and prevent degradation.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear solution
Identification (Mass Spec)	Conforms to reference standard
Purity (SEC-HPLC)	≥ 98.0% (Monomer)
Assay (Protein Content)	90.0% - 110.0% of label claim
Biological Activity (Cell-based)	Meets potency specifications
Endotoxin	< 1.0 EU/mg
Host Cell Protein (HCP)	< 100 ppm
Host Cell DNA	< 10 pg/mg
Moisture Content (KF)	< 3.0% (for lyophilized form)

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.