CellGenix® rh FGF-2 (Preclinical Grade)

Tech Support
CellGenix® rh FGF-2 (Preclinical Grade)
 

Top Features for Recombinant Human Fibroblast Growth Factor2:

  • Optimal use for expansion of MSCs and maintenance of undifferentiated PSCs
  • ADCF Level 1
  • High purity to ensure the safety of your process
  • Available in two different grades (Preclinical and GMP grade)

Preclinical grade:

  • Intended for preclinical ex vivo use
  • GMP transferable: Seamless transition from preclinical development to commercial manufacturing

GMP grade:

  • Intended for clinical ex vivo use
  • Endotoxin Level ≤ 50 EU/mg
  • Manufactured in accordance with applicable GMP guidelines
  • FDA Drug Master File (DMF) available
  • Technical and regulatory support available

Size
Quality Grade
Item No.: 
1421-050
Availability: 

*Custom/bulk order quotes are provided within 72 hours of request.

CellGenix® Recombinant Human Fibroblast Growth Factor-2 (FGF-2) is an animal-derived component-free product. It is produced in a dedicated GMP facility. FGF-2 is used in the cell and gene therapy space for the expansion of bone marrow and adipose tissue derived mesenchymal stem cells (MSCs).

GMP grade: CellGenix® Recombinant Human FGF-2 is produced following applicable GMP guidelines and allows for the safe use in accordance with USP Chapter <1043>, Ph. Eur. General Chapter 5.2.12 and ISO 20399:2022.

CellGenix® GMP cytokines are provided with documented evidence of purity, potency, consistency and stability. In combination with our expert regulatory and technical support this will help simplify your raw material qualification and validation efforts.

Expiry: ≥ 6 months from date of shipping.

We have submitted Drug Master Files (DMFs) to US Health Authorities to support our customers’ regulatory activities. These Master Files can be cross-referenced through Letters of Authorization (LOAs) in Marketing Authorizations, IND, BLA, NDA, ANDA or other DMF applications. Please submit your Authorization Request via the form above.

Preclinical grade: Designed to meet the demands of translational research, CellGenix® Preclinical cytokines are ideal to bridge the gap between the lower quality of research grade and the higher costs of GMP grade materials.

Expiry: 3 years from date of shipping

For the exact expiry date and the batch specific activity, please refer to the Certificate of Analysis on the My Sartorius Portal.

Applications

  • Application
    Preclinical ex vivo use
  • Application Area
    • Cell & gene therapy
    • Immunology
  • Cell Type
    • MSC
    • ESC/iPSC
    • Chondrocytes
    • Neuronal Cells
    • Organoids
  • Intended Use
    Preclinical ex vivo use

Biological Information

  • Activity
    ≥ 0.9 x 106 IU/mg

Compliance Information

  • Origin
    Animal-Component Free
  • Quality Grade
    Preclinical

Features

  • Carrier-Protein Free
    Yes

Physicochemical Information

  • Endotoxin
    ≤ 1 EU/µg
  • Expression System
    E. coli
  • Formulation
    Lyophilized from a 0.2 µm-filtered solution containing 25 mM sodium phosphate, 400 mM sodium chloride, 10 mM glutathione (red.) and 5% mannitol, pH 6.5

Product Information

  • Brand
    CellGenix®
  • Package Type
    Vial
  • Size
    50 µg

Sterility/Purity

  • Delivery Condition
    Sterile
  • Purity
    ≥ 95%

Weight

  • Molecular Weight (kDa)
    17.3 kDa