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CellGenix® GMP rh TGF-beta 1

Top Features for Recombinant Transforming Growth Factor-beta 1:

  • Optimal use of expansion of HSC's
  • Xeno -free, ADCF Level 2
  • High purity to ensure the safety of your process
  • Available in two different grades (Preclincal and GMP grade)

Preclinical grade:

  • Intended for preclinical ex vivo use
  • Endotoxin Level ≤ 10 EU/mg
  • GMP transferable: Seamless transition from preclinical development to commercial manufacturing

GMP grade:

  • Intended for clinical ex vivo use
  • Endotoxin Level ≤ 10 EU/mg
  • Manufactured in accordance with applicable GMP guidelines
  • FDA Drug Master File (DMF) available
  • Technical and regulatory support available

Item no.:  1026-050

Price (USD):  $2,114.00

 

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® GMP Recombinant Human Transforming Growth Factor-beta 1 (TGF-β1) is a xeno-free and animal-derived component-free product. It is produced in a dedicated GMP facility. TGF-β1 is used in the cell and gene therapy space to promote expansion of induced pluripotent stem cells (iPSCs), embryonic stem cells (ESCs), mesenchymal stem cells (MSCs) and regulatory T cells (Tregs). CellGenix® Recombinant Human TGF-β1 is produced using a human amniocyte cell line (CAP®) to enable authentic human post-translational modifications.

CAP® is a registered trademark of CEVEC Pharmaceuticals GmbH, Germany.

CellGenix® GMP Recombinant Human TGF-β1 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.

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Tech Note:

ADCF Policy

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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:

Quality TGF-β1

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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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Datasheet

CellGenix GMP Recombinant Human Transforming Growth Factor-beta 1 (rh TGF-ß1)
en 422.2 kB

Safety Datasheet

Safety Datasheet: CellGenix® Recombinant Human TGF-β1
en 217.3 kB

Technical Note

CellGenix rh TGF-ß1 - Preclinical vs GMP
en 1.0 MB

Applications

  • Application
    Clinical ex vivo use (small)
  • Application Area
    • Cell & Gene Therapy
    • Immunology
    • Neuroscience
  • Cell Type
    • MSC
    • ESC/iPSC
    • T Cells

Biological Information

  • Activity
    9 – 36 x 106&nbsp;IU/mg

Compliance Information

  • GMP Compliance
    This product was manufactured in conformance with established Current Good Manufacturing Practice (cGMP) standards.
  • Origin
    Animal-Component Free

Physicochemical Information

  • Endotoxin
    ≤ 10 EU/mg
  • Expression
    CAP® cell line
  • Formulation
    Lyophilized from a 0.2 µm-filtered solution containing 1% Mannitol

Product Information

  • Brand
    CellGenix®
  • Package Type
    Vial

Sterility

  • Delivery Condition
    Sterile
  • Purity
    ≥ 97%

Volumes

  • Volume
    50 µg

Weights

  • Molecular Weight (kDa)
    25.6 kDa