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CellGenix®rh FGF-2 (GMP 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

Item no.:  1021-050

Price (USD):  $1,453.00

 

* 72 Hours Turnaround Time

CellGenix® rh Cytokines - Preclinical vs GMP

Both product grades are produced under the same conditions in a GMP facility, ensuring an equal product quality and performance. We offer a more comprehensive QC testing including tighter specifications and documentation for our GMP products: CellGenix® rh Cytokines - Preclinical vs GMP

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).

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

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

Please refer to Certificate of Analysis https://my.sartorius.com/login for the exact expiry date and the batch specific activity.

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. Submit your Authorization Request here https://cellgenix.com/dmf-letter-of-authorization-request-form-2/

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App Note:

Reliable T Cell Expansion with CellGenix®️ rh IL-2

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Tech Note:

ADCF Policy

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Tech Note:

Shipment at Ambient Temperatures

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Certificate of Analysis:

Download on the My Sartorius portal

My Sartorius
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Tech Note:

Stability of GMP Cytokines after Reconstitution 

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Tech Note:

Batch-to-Batch Consistency of CellGenix® GMP Cytokines

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Applications

  • Application
    Clinical ex vivo use (small)
  • Application Area
    • Cell & Gene Therapy
    • Epithelial Cell Biology
    • Neuroscience
    • Stem Cell Biology
  • Cell Type
    • MSC
    • ESC/iPSC
    • Chondrocytes

Biological Information

  • Activity
    0.9 – 3 x 106 IU/mg

Compliance Information

  • GMP Compliance
    This product was manufactured in accordance with applicable Good Manufacturing Practice (GMP) guidelines.
  • Origin
    Animal-Component Free

Physicochemical Information

  • Endotoxin
    ≤ 50 EU/mg
  • Expression
    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

Sterility

  • Delivery Condition
    Sterile
  • Purity
    ≥ 97%

Volumes

  • Volume
    50 µg

Weights

  • Molecular Weight (kDa)
    17.3 kDa