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

Package Type
Item No.: 
20802-0500
Availability: 

*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)

Also available without Phenol Red

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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.

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Tech Note:

ADCF and Serum-free Policy

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Tech Note:

Shipment of GMP Media at Ambient Temperatures

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Certificate of Analysis:

Download on the My Sartorius portal

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Applications

  • Application
    Clinical ex vivo use
  • Application Area
    • Cell & gene therapy
    • Immunology
    • Stem cell biology
  • Cell Type
    • HSC
    • NK Cells
    • CIK Cells

Biological Information

  • Functional Assay
    Expansion of human CD34+ cells

Compliance Information

  • GMP Compliance
    This product was manufactured in accordance with applicable Good Manufacturing Practice (GMP) guidelines.
  • Origin
    Xeno-Free

Components

  • Phenol Red Indicator
    With Phenol Red

Features

  • Serum Free
    Yes

General Specifications

  • pH Range
    pH 7.2 – 7.5

Physicochemical Information

  • Adherence/Suspension
    Adherent/Suspension
  • Endotoxin
    ≤ 1 EU/ml
  • Osmolality
    290-350 mOsm/kg H2O

Product Information

  • Brand
    CellGenix®
  • Package Type
    Bottle

Sterility/Purity

  • Delivery Condition
    Sterile
  • Mycoplasma
    Not detectable

Volume

  • Volume
    500mL