CellGenix® rh GM-CSF (GMP Grade)
Top Features for Recombinant Human Granulocyte-Macrophage Colony-Stimulating Factor:
- Optimal use for expansion of MSCs and maintenance of undifferentiated PSCs
- 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
- 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.:
- 1012-1000
*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
CellGenix®Recombinant Human Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) is an animal-derived component-free product. It is produced in a dedicated animal-free GMP facility. GM-CSF is used in the cell and gene therapy space for its ability to promote dendritic cell (DC) differentiation and function as well as macrophage activity. It is considered a critical factor for the development of DC therapies..
GMP grade: CellGenix®Recombinant Human GM-CSF 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.
Datasheet
Applications
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ApplicationClinical ex vivo use (large)
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Application Area
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Cell & gene therapy
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Immunology
- Stem cell biology
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Cell & gene therapy
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Cell TypeDC
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Intended UseFor further manufacturing use
Biological Information
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Activity8 – 14 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≤ 0.05 EU/µg
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Expression SystemE. coli
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FormulationLyophilized from a 0.2 µm-filtered solution containing 1.5 mM potassium phosphate, 8.1 mM sodium phosphate, 2.7 mM potassium chloride and 137 mM sodium chloride, pH 7.5
Product Information
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BrandCellGenix®
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Package TypeVial
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Size1 mg
Sterility/Purity
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Delivery ConditionSterile
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Purity≥ 97%
Weight
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Molecular Weight (kDa)14.5 kDa