CellGenix® GMP SCGM
- Optimized, xeno-free, serum-free medium
- Serum-free expansion of low numbers of isolated human hematopoietic stem and progenitor cells (HSCs/CD34+ cells)
- Highly efficient for the expansion and cultivation of human natural killer cells (NK cells) and human cytokine induced killer cells (CIK cells)
- Manufactured in accordance with applicable GMP guidelines
- FDA & PMDA Drug Master Files (DMFs) are available
- Outstanding QC support (e.g. extensive stability data)
- Technical and regulatory support
- Item No.:
- 20802-0500
*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® GMP Stem Cell Growth Medium is an optimized, xeno-free medium used for the serum-free expansion of low numbers of isolated human hematopoietic stem and progenitor cells (HSCs/CD34+ cells). In addition, CellGenix® GMP Stem Cell Growth Medium is proved to be highly efficient for the expansion and cultivation of human natural killer cells (NK cells) and human cytokine induced killer cells (CIK cells).
Please access the Certificate of Analysis on the My Sartorius Portal.
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.
Applications
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ApplicationClinical ex vivo use
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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 Type
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HSC
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NK Cells
- CIK Cells
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HSC
Biological Information
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Functional AssayExpansion of human CD34+ cells
Compliance Information
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GMP ComplianceThis product was manufactured in accordance with applicable Good Manufacturing Practice (GMP) guidelines.
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OriginXeno-Free
Components
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Phenol Red IndicatorWith Phenol Red
Features
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Serum FreeYes
General Specifications
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pH RangepH 7.2 – 7.5
Physicochemical Information
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Adherence/SuspensionAdherent/Suspension
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Endotoxin≤ 1 EU/ml
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Osmolality290-350 mOsm/kg H2O
Product Information
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BrandCellGenix®
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Package TypeBottle
Sterility/Purity
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Delivery ConditionSterile
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MycoplasmaNot detectable
Volume
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Volume500mL