Description

Teplizumab CAS NO 876387-05-2 is a humanized monoclonal antibody designed to modulate the immune system. This compound is of significant commercial and therapeutic interest for its targeted mechanism of action. It is primarily required by pharmaceutical developers, biotechnology companies, and clinical research organizations engaged in advanced immunotherapy.

Application

• Type 1 Diabetes (T1D) Immunotherapy: As a primary therapeutic agent to delay the onset of clinical stage 3 type 1 diabetes in at-risk individuals.
• Autoimmune Disease Research: For in vitro and in vivo studies investigating T-cell mediated autoimmune pathways.
• Drug Substance (API): Serves as the active pharmaceutical ingredient in the formulation of finished biologic drug products.
• Clinical Trial Materials: Used in the manufacturing of supplies for Phase I, II, and III clinical studies.
• Biologic Reference Standard: Acts as a high-purity standard for analytical method development and quality control testing.
• Mechanism of Action Studies: Utilized in research to further elucidate the interaction with CD3 on T lymphocytes.

Basic Information

Product Name	Teplizumab
CAS No.	876387-05-2
Molecular Formula	Contact for details
Molecular Weight	Approx. 150 kDa (Contact for details)
Synonyms	Teplizumab; Anti-CD3 Monoclonal Antibody (hOKT3γ1(Ala-Ala)); MGA031; hOKT3γ1(Ala-Ala); PRV-031; Anti-Human CD3 Epsilon Monoclonal Antibody (hOKT3γ1(Ala-Ala)); Therapeutic Anti-CD3 Antibody
EINECS	Contact for details

Quality Control

Our Teplizumab is manufactured and controlled under a stringent quality management system. Each batch is tested to ensure identity, purity, potency, and safety, meeting exacting standards for biologic active substances. Certificates of Analysis (COA) documenting comprehensive testing, including but not limited to HPLC purity, bioassay, endotoxin, and sterility, are provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store frozen at -20°C to -70°C. Avoid repeated freeze-thaw cycles. Under these conditions, the product remains stable for the duration specified on the certificate of analysis. This product is hygroscopic (moisture-sensitive).

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear to slightly opalescent solution
Identification (HPLC/MS)	Conforms to reference standard
Purity (SEC-HPLC)	≥ 95.0% (Monomer)
Purity (RP-HPLC)	≥ 90.0% (Main Peak)
Potency (Cell-based Bioassay)	90% - 120% of reference
Protein Content (A280)	90% - 110% of label claim
Endotoxin	< 1.0 EU/mg
Sterility (Membrane Filtration)	Sterile

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