Description

Filgrastim (Granulocyte Colony-Stimulating Factor, G-CSF) is a recombinant human granulocyte colony-stimulating factor, a critical therapeutic protein used to stimulate the production of white blood cells. Its primary value lies in its ability to reduce the risk of infection in patients undergoing myelosuppressive chemotherapy, bone marrow transplantation, or suffering from severe chronic neutropenia. This product is essential for pharmaceutical manufacturers, biotechnology companies, and clinical research organizations developing and producing advanced biologic therapies and biosimilars.

Application

• Oncology Supportive Care: Primary application for the reduction in the duration of neutropenia and incidence of febrile neutropenia in patients receiving cytotoxic chemotherapy.
• Hematopoietic Stem Cell Transplantation: Used to mobilize peripheral blood progenitor cells (PBPCs) for collection and subsequent transplantation, and to accelerate neutrophil recovery post-transplant.
• Severe Chronic Neutropenia (SCN): Treatment for patients with congenital, cyclic, or idiopathic neutropenia to increase neutrophil counts and reduce infections.
• Biosimilar Development: Serves as the active pharmaceutical ingredient (API) for companies developing and manufacturing biosimilar versions of branded G-CSF therapies.
• Clinical Research: Used as a reference standard or investigational product in preclinical and clinical studies focused on immunology and hematology.
• Advanced Therapy Medicinal Products (ATMPs): Potential use in combination cell therapies to support immune cell proliferation and engraftment.

Basic Information

Product Name	Filgrastim (Granulocyte Colony-Stimulating Factor)
CAS No.	143011-72-7
Molecular Formula	C845H1343N223O243S9
Molecular Weight	Approx. 18,800 Da
Synonyms	Recombinant Human G-CSF; Granulocyte Colony-Stimulating Factor; G-CSF; Filgrastim; Granulokine; Neupogen (Brand Name); r-metHuG-CSF; Granulocyte Colony Stimulating Factor (Human); Granulocyte-Stimulating Factor; Colony Stimulating Factor 3 (CSF 3); Plerixafor combination agent; Myeloid growth factor.
EINECS	Contact for details

Quality Control

Our Filgrastim is manufactured under strict quality management 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) detailing specifications such as biological activity (IU/mg), purity by HPLC, and tests for host cell proteins and DNA are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C. Do not freeze. This 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 or off-white lyophilized powder or clear solution
Identification (HPLC/MS)	Conforms to reference standard
Purity (SEC-HPLC)	≥ 98.0%
Purity (RP-HPLC)	≥ 95.0%
Biological Activity	≥ 1.0 x 108 IU/mg
Protein Content	UV Spectroscopy
pH	3.5 - 4.5 (for solution)
Endotoxin	< 10 EU/mg
Host Cell Protein (HCP)	< 100 ppm
Host Cell DNA	< 10 pg/mg
Sterility	Sterile

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