CellGenix® GMP DC Medium
- Optimized, xeno-free, serum-free medium
- Engineered for the generation of human dendritic cells (DCs)
- Promotes high yields of mature dendritic cells with the desired phenotype
- Manufactured in accordance with applicable GMP guidelines
- FDA Drug Master File (DMF) is available
- Outstanding QC support (e.g. extensive stability data)
- Technical and regulatory support
- Item No.:
- 20901-0500
*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 Dendritic Cell Medium is an optimized, xeno-free medium used for the serum-free generation of human dendritic cells (DCs). It promotes high yields of mature dendritic cells with the desired phenotype.
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
- Immunology
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Cell & gene therapy
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Cell TypeDC
Biological Information
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Functional AssayGeneration of human dendritic cells from CD14+ monocytes
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
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Endotoxin≤ 1 EU/ml
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Osmolality260-320 mOsm/kg H2O
Product Information
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BrandCellGenix®
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Package TypeBag
Sterility/Purity
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Delivery ConditionSterile
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MycoplasmaNot detectable
Volume
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Volume500mL