Description

Atezolizumab is a humanized monoclonal antibody designed as a programmed death-ligand 1 (PD-L1) blocking agent. This compound is critical for its role in cancer immunotherapy, specifically by inhibiting the PD-1/PD-L1 pathway to restore the body's anti-tumor immune response. It is primarily required by the pharmaceutical and biotechnology sectors for the research, development, and manufacturing of targeted oncology therapeutics, particularly for treating various carcinomas.

Application

• Oncological Therapeutics: Key active pharmaceutical ingredient (API) in the formulation of immunotherapeutic drugs for cancers such as urothelial carcinoma, non-small cell lung cancer (NSCLC), and triple-negative breast cancer (TNBC).
• Biopharmaceutical Research: Used as a reference standard and critical reagent in preclinical and clinical research to study PD-L1 inhibition mechanisms and efficacy.
• Drug Development: Serves as a core component in the development and scale-up of new biologic drug candidates targeting immune checkpoints.
• Biosimilar Development: Employed as a comparator in analytical and bioanalytical studies for the development of biosimilar versions of atezolizumab.
• Clinical Trial Material (CTM): Supplied as a high-purity ingredient for the manufacture of clinical trial supplies for Phase I-III studies.
• Cell-Based Assays: Utilized in in vitro assays to evaluate T-cell activation and tumor cell killing in immunology research.

Basic Information

Product Name	Atezolizumab
CAS No.	1380723-44-3
Molecular Formula	C6448H10012N1724O2018S44
Molecular Weight	Approx. 145 kDa
Synonyms	MPDL3280A; RG7446; Anti-PD-L1 Monoclonal Antibody; Tecentriq (Brand Name); Atezolizumab Injection; Immunoglobulin G1, anti-(human protein B7-H1) (human-mouse monoclonal MPDL3280A γ1-chain), disulfide with human-mouse monoclonal MPDL3280A κ-chain, dimer; PD-L1 Inhibitor Atezolizumab; Atezolizumab (USAN)
EINECS	Contact for details

Quality Control

Our Atezolizumab is manufactured and controlled under a quality management system compliant with cGMP guidelines for active pharmaceutical ingredients (APIs). Each batch undergoes rigorous analytical testing including purity assessment by SEC-HPLC and CE-SDS, potency via cell-based bioassays, and comprehensive characterization for identity, charge variants, and post-translational modifications. Certificates of Analysis (COA) detailing full specifications and test results are provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store lyophilized powder at -20°C or below. Reconstituted or liquid formulations should be stored at 2-8°C and used within the specified timeframe. Avoid repeated freeze-thaw cycles.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear to slightly opalescent solution
Identification (SEC-HPLC)	Conforms to reference standard
Purity (Monomer by SEC-HPLC)	≥ 98.0%
Purity (CE-SDS, Non-reduced)	Main peak ≥ 95.0%
Protein Content (A280)	95.0 - 105.0% of label claim
Potency (Cell-Based Bioassay)	90.0 - 120.0% of reference
Endotoxin	< 1.0 EU/mg
pH	5.5 - 6.5 (for solution)

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