Description

Cenegermin CAS NO 1772578-74-1 is a recombinant human nerve growth factor (rhNGF) analog, representing a significant advancement in targeted ophthalmic therapeutics. This engineered protein is specifically designed to promote corneal healing and nerve regeneration. It is a critical active pharmaceutical ingredient (API) for the formulation of advanced prescription eye drops, primarily targeting the treatment of neurotrophic keratitis. Pharmaceutical manufacturers and research institutions engaged in developing novel biologic treatments for ocular surface diseases are the primary users of this high-purity compound.

Application

• Primary API for Prescription Ophthalmic Solutions: The core application is as the active ingredient in eye drop formulations for treating moderate to severe neurotrophic keratitis.
• Biopharmaceutical R&D: Used in research to study nerve growth factor (NGF) signaling pathways, corneal wound healing mechanisms, and neuroprotection.
• Formulation Development: Serves as a reference standard in the development and stability testing of novel biologic ophthalmic drug delivery systems.
• Preclinical & Clinical Studies: Essential for conducting pharmacological, toxicological, and clinical trial material manufacturing for new ophthalmic indications.
• Cell Culture & Tissue Engineering: Potential use in specialized media for cultivating corneal epithelial cells and in research on tissue-engineered corneal constructs.

Basic Information

Product Name	Cenegermin
CAS No.	1772578-74-1
Molecular Formula	C692H1108N192O208S10
Molecular Weight	Approx. 15.8 kDa
Synonyms	Recombinant Human Nerve Growth Factor (rhNGF); Oxervate (Brand Name); Nervalgen; rhNGF; Nerve Growth Factor, Human, Recombinant; NGF; Cenegermin-bkbj; Recombinant Human β-Nerve Growth Factor
EINECS	Contact for details

Quality Control

Our Cenegermin is manufactured under strict cGMP (current Good Manufacturing Practice) guidelines to ensure the highest standards of purity, potency, and consistency required for pharmaceutical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing critical quality attributes such as identity, purity (by HPLC), biological activity, endotoxin levels, and residual host cell proteins/DNA. We adhere to ICH Q6B specifications for biotechnological products, ensuring compliance for global regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store lyophilized (freeze-dried) powder at -20°C or below. Once reconstituted, the solution should be used immediately or stored as directed for the final formulation, typically at 2-8°C for a limited duration. The product is hygroscopic (moisture-sensitive) and must be handled in a controlled, low-humidity environment.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder
Identification (HPLC/MS)	Conforms to reference standard
Purity (RP-HPLC)	≥ 98.0%
Biological Activity (Cell-based assay)	≥ 1.0 x 106 IU/mg
Endotoxin	< 1.0 EU/mg
Protein Content (UV)	≥ 95.0%
Residual Moisture (KF)	≤ 3.0%
Sterility (Membrane Filtration)	Sterile

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