Description

Gemtuzumab CAS NO 220578-59-6 is a targeted monoclonal antibody-drug conjugate (ADC) specifically designed for therapeutic applications. This product is critical for pharmaceutical research and development, offering a precise mechanism of action for targeted cell therapy. It is primarily utilized by pharmaceutical manufacturers, biotechnology companies, and advanced research institutions engaged in oncology drug development and biopharmaceutical production.

Application

• Oncological Therapeutics: Primary use in the formulation of targeted treatments for specific types of leukemia, notably acute myeloid leukemia (AML).
• Biopharmaceutical R&D: Serves as a key reference standard and active pharmaceutical ingredient (API) in the development of novel antibody-drug conjugates and targeted cancer therapies.
• Clinical Trial Material: Used in the manufacturing of investigational drugs for Phase I-III clinical studies in oncology.
• Cell Biology Research: Employed in laboratory studies to investigate targeted drug delivery mechanisms and antibody-mediated cellular cytotoxicity.
• GMP Manufacturing: Integral component in Good Manufacturing Practice (GMP) production processes for commercial-scale biotherapeutic drugs.

Basic Information

Product Name	Gemtuzumab
CAS No.	220578-59-6
Molecular Formula	C6470H10012N1732O2010S42
Molecular Weight	~150-160 kDa
Synonyms	Gemtuzumab Ozogamicin; CMA-676; WAY-CMA-676; Mylotarg; Anti-CD33 Monoclonal Antibody-Calicheamicin Conjugate; hP67.6-Calicheamicin; CDP-771
EINECS	Contact for details

Quality Control

Our Gemtuzumab is produced and tested under stringent quality systems to ensure it meets the exacting standards required for pharmaceutical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, potency, and impurity profiles. We adhere to relevant guidelines for biopharmaceuticals, and specifications can be aligned with pharmacopeial standards (e.g., USP) upon request to support regulatory filings.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C. This product is hygroscopic (moisture-sensitive) and should be handled under controlled conditions to prevent degradation. For long-term storage, consider aliquoting and storing at ≤ -20°C under desiccant.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or solid
Identification (HPLC/MS)	Conforms to reference standard
Purity (SEC-HPLC)	≥ 95.0% (Monomer)
Assay (HPLC)	90.0% - 110.0% of label claim
Protein Content	Determined by UV absorbance
Drug-to-Antibody Ratio (DAR)	Specified range per batch
Endotoxin	< 1.0 EU/mg
Sterility (where applicable)	Sterile

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