Description

Lenograstim is a recombinant human granulocyte colony-stimulating factor (G-CSF) analog, a critical therapeutic protein used to stimulate the production of white blood cells. Its primary commercial value lies in its application as a supportive care agent in oncology to manage chemotherapy-induced neutropenia, thereby reducing the risk of infection and enabling treatment continuity. This product is essential for pharmaceutical manufacturers, research institutions, and clinical facilities engaged in developing and producing advanced biopharmaceuticals and targeted therapies.

Application

• Oncology Supportive Care: Primary use for the prevention and treatment of neutropenia in patients undergoing myelosuppressive chemotherapy.
• Hematopoietic Stem Cell Transplantation: Mobilization of peripheral blood progenitor cells (PBPCs) for collection prior to transplantation.
• Severe Chronic Neutropenia (SCN): Long-term administration to increase neutrophil counts and reduce the incidence of infections in patients with congenital, cyclic, or idiopathic neutropenia.
• Pharmaceutical Intermediates: Serves as a key active pharmaceutical ingredient (API) in the formulation of injectable biopharmaceutical products.
• Biosimilar Development: Critical reference material for R&D and quality control in the development of biosimilar G-CSF products.
• Clinical Research: Used in preclinical and clinical studies investigating immune system modulation and hematopoietic recovery.

Basic Information

Product Name	Lenograstim
CAS No.	135968-09-1
Molecular Formula	C845H1343N223O243S9
Molecular Weight	Approx. 18,800 Da
Synonyms	Granocyte; Recombinant Human G-CSF (CHO derived); G-CSF, Human (CHO); Granulocyte Colony-Stimulating Factor (rHuG-CSF); r-metHuG-CSF; NSC-614383; 5T4-Fc GCSF fusion protein; Lenograstim [INN]; Lenograstimum [Latin]
EINECS	Contact for details

Quality Control

Our Lenograstim 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 Q6B guidelines for biotechnological products. Certificates of Analysis (COA) are provided, detailing specifications for biological activity, protein content, and purity by HPLC. We support compliance with cGMP, FDA, and EMA regulatory requirements for active pharmaceutical ingredients.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C. Do not freeze. The product is hygroscopic (moisture-sensitive) and must be protected from exposure to high humidity. For long-term stability, maintain the recommended cold chain conditions.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or solid
Identification (HPLC/MS)	Conforms to reference standard
Purity (RP-HPLC)	≥ 98.0%
Biological Activity	≥ 1.0 x 108 IU/mg
Protein Content	≥ 95.0% (by UV)
Endotoxin	< 10 EU/mg
Residual Host Cell DNA	< 10 pg/mg
Residual Host Cell Protein	< 100 ppm
Moisture (KF)	< 3.0%

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