Description

Alemtuzumab is a recombinant, humanized monoclonal antibody targeting the CD52 antigen, widely recognized for its therapeutic applications. This product is critical for researchers and manufacturers in the biopharmaceutical sector requiring a high-purity, well-characterized biologic for development and production. It is primarily utilized in the formulation of targeted therapies for specific autoimmune and hematological conditions, serving the needs of advanced pharmaceutical R&D and bioprocessing industries.

Application

• Active Pharmaceutical Ingredient (API) in the manufacture of targeted therapeutic drugs.
• Key reagent in biomedical research for studying immune cell depletion and modulation.
• Critical component in the development of biosimilar and biobetter candidates.
• Used in process development and scale-up activities within biopharmaceutical manufacturing.
• Reference standard for quality control and analytical method validation in QC laboratories.

Basic Information

Product Name	Alemtuzumab
CAS No.	216503-57-0
Molecular Formula	C6458H10008N1732O2010S40
Molecular Weight	Approx. 150 kDa
Synonyms	Campath-1H; Anti-CD52 Monoclonal Antibody; LDP-03; IGN-101; hIgG1-kappa, anti-(human CD52); Monoclonal Antibody Campath-1H; Recombinant Humanized Anti-CD52 IgG1 kappa; CD52 Antagonist
EINECS	Contact for details

Quality Control

Our Alemtuzumab is manufactured under strict quality systems. Each batch is subjected to a comprehensive battery of analytical tests to ensure identity, purity, potency, and safety, aligning with ICH guidelines. A Certificate of Analysis (COA) detailing specifications such as purity by HPLC, biological activity, and endotoxin levels is provided with every shipment to guarantee consistent quality and traceability.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store at -20°C or below. Avoid repeated freeze-thaw cycles. The product is hygroscopic (moisture-sensitive); ensure containers are sealed under controlled humidity conditions upon opening.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear solution
Identification (HPLC/MS)	Conforms to reference standard
Purity (SEC-HPLC)	≥ 95.0% (Monomer)
Protein Content (UV/A280)	As per COA
Biological Activity (Cell-based assay)	As per COA
Endotoxin	< 1.0 EU/mg
Host Cell Proteins (HCP)	< 100 ppm
Residual DNA	< 10 pg/mg

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