Description

Obinutuzumab CAS NO 949142-50-1 is a humanized, glycoengineered, type II anti-CD20 monoclonal antibody. It is a critical therapeutic agent designed for targeted immunotherapy, offering enhanced antibody-dependent cellular cytotoxicity (ADCC) and direct cell death induction. This product is essential for pharmaceutical manufacturers and research institutions developing and producing advanced treatments for specific hematologic malignancies.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the active component in commercial drug formulations for targeted cancer therapy.
• Oncology Therapeutics: Manufacture of biologic drugs indicated for the treatment of chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL).
• Clinical Research & Development: Serves as a reference standard or key reagent in preclinical and clinical studies exploring novel anti-CD20 mechanisms and combination therapies.
• Biopharmaceutical Process Development: Used in scale-up and optimization studies for monoclonal antibody production, purification, and formulation processes.
• Biosimilar Development: Acts as a critical comparator in analytical and functional characterization for the development of biosimilar products.

Basic Information

Product Name	Obinutuzumab
CAS No.	949142-50-1
Molecular Formula	C6514H10066N1714O2016S44
Molecular Weight	Approx. 146 kDa
Synonyms	GA101; RO5072759; Gazyva (trade name); Gazyvaro (trade name); Anti-CD20 Monoclonal Antibody (glycoengineered, type II); Humanized IgG1 kappa Anti-CD20; Obinutuzumab (USAN/INN)
EINECS	Contact for details

Quality Control

Our Obinutuzumab is manufactured and tested under strict quality systems to ensure it meets the rigorous standards required for pharmaceutical development. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing critical quality attributes such as purity, potency, and identity. We adhere to relevant cGMP guidelines and can provide material suitable for research and commercial development phases.

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 protected from freezing. This product is hygroscopic (moisture-sensitive); ensure containers are sealed under controlled, dry conditions to maintain stability and potency.

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)	≥ 98.0% (Monomer)
Assay (Protein Content)	90.0% - 110.0% of label claim
Potency (Bioassay)	Within specified range
Endotoxin	< 1.0 EU/mg
Host Cell Protein	< 100 ppm
Residual DNA	< 10 pg/mg
pH	5.5 - 6.5 (for solution)
Moisture Content (K.F.)	< 3.0% (for lyophilized powder)

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