CellGenix® rh TGF-β1 (GMP grade)
Top Features for Recombinant Transforming Growth Factor-beta 1:
- Optimal use of expansion of HSC's
- ADCF Level 2
- 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
- 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
*Custom/bulk order quotes are provided within 72 hours of request.
Letter of Authorization (LOA)
Place a request for a Letter of Authorization (LOA) for our Drug Master File (FDA)
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
Choose your CellGenix® Growth Factors and Cytokines
CellGenix® Recombinant Human Transforming Growth Factor-beta 1 (TGF-β1) is an 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.
GMP grade: CellGenix® Recombinant Human TGF-β1 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.
Safety Data Sheets (SDSs) are available on request.
Technical Note
Applications
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ApplicationClinical ex vivo use (small)
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Application Area
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Cell & gene therapy
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Immunology
- Neuroscience
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Cell & gene therapy
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Cell Type
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MSC
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ESC/iPSC
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T Cells
- Organoids
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MSC
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Intended UseFor further manufacturing use
Biological Information
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Activity9 – 36 x 106 IU/mg
Compliance Information
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GMP ComplianceThis product was manufactured in accordance with applicable Good Manufacturing Practice (GMP) guidelines.
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OriginAnimal-Component Free
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Quality GradeGMP
Features
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Carrier-Protein FreeYes
Physicochemical Information
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Endotoxin≤ 0.010 EU/µg
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Expression SystemCAP® cell line
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FormulationLyophilized from a 0.2 µm-filtered solution containing 1% mannitol
Product Information
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BrandCellGenix®
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Package TypeVial
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Size50 µg
Sterility/Purity
-
Delivery ConditionSterile
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Purity≥ 97%
Weight
-
Molecular Weight (kDa)25.6 kDa