Description

Palifermin is a recombinant human keratinocyte growth factor (KGF) used to stimulate the growth and repair of epithelial cells. This pharmaceutical-grade protein is critical for mitigating severe oral mucositis, a debilitating side effect of chemotherapy and radiation treatment in cancer patients. It is primarily utilized by pharmaceutical manufacturers and clinical research organizations developing and producing targeted supportive care therapies for oncology.

Application

• Oncology Supportive Care: Primary use in the prevention and treatment of severe oral mucositis in patients with hematologic malignancies undergoing high-dose chemotherapy and total body irradiation.
• Pharmaceutical Manufacturing: Active Pharmaceutical Ingredient (API) for the formulation of injectable biologic drugs.
• Clinical Research: Key reagent in preclinical and clinical studies investigating epithelial tissue protection and regeneration.
• Biologics Development: Used in research focused on growth factor therapies for gastrointestinal mucosal injury.
• Reference Standard: Serves as a high-purity standard for analytical method development and quality control testing in biopharmaceutical labs.

Basic Information

Product Name	Palifermin
CAS No.	162394-19-6
Molecular Formula	C808H1303N233O245S9
Molecular Weight	Approx. 18,400 Da
Synonyms	Recombinant Human Keratinocyte Growth Factor (rHuKGF); Keratinocyte Growth Factor, Human Recombinant; KGF; Fibroblast Growth Factor-7 (FGF-7); FGF7; rFGF-7; Kepivance® (brand name); rHuKGF; Palifermin (INN)
EINECS	Contact for details

Quality Control

Our Palifermin is manufactured under strict cGMP guidelines to ensure the highest standards of purity, potency, and consistency. Each batch is subjected to a comprehensive battery of analytical tests including identity confirmation, purity assay, bioactivity testing, and stringent impurity profiling (host cell proteins, DNA, endotoxins). A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with relevant pharmacopeial and ICH Q6B specifications for biotechnology-derived products.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below. This product is hygroscopic (moisture-sensitive) and should be handled under controlled conditions to maintain stability. For long-term storage, keep desiccated.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or solid
Identification (HPLC/MS)	Conforms to reference standard
Purity (SDS-PAGE & SEC-HPLC)	≥ 98.0%
Assay (Bioactivity)	≥ 1.0 x 106 units/mg
Endotoxin	< 1.0 EU/mg
Host Cell Protein (HCP)	< 10 ppm
Host Cell DNA	< 10 pg/mg
Moisture Content (KF)	< 3.0%

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