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CellGenix® GMP rh IL-10

Top Features for Recombinant Human Interleukin-10:

  • Optimal use for expansion of MSCs and maintenance of undifferentiated PSCs
  • Xeno -free, ADCF Level 2
  • High purity to ensure the safety of your process
  • Available in two different grades (Preclincal 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.:  1014-050

Price (USD):  $1,510.00

 

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® GMP Recombinant Human Interleukin-10 (IL-10) is a xeno-free and animal-derived component-free product. It is produced in a dedicated animal-free GMP facility. IL-10 is used in the cell and gene therapy space to support the generation of anti-inflammatory dendritic cells (DCs).

CellGenix® GMP Recombinant Human IL-10 is produced following all applicable GMP guidelines and allows for the safe use in accordance with USP Chapter <1043>, Ph. Eur. General Chapter 5.2.12 and ISO Technical Standard 20399.

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

Please refer to Certificate of Analysis https://my.sartorius.com/login for the exact expiry date and the batch specific activity.

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Tech Note:

ADCF Policy

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Tech Note:

ADCF and Serum-free Policy

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Tech Note:

Shipment at Ambient Temperatures

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Certificate of Analysis:

Download on the My Sartorius portal

My Sartorius
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Tech Note:

Shipment of GMP Media at Ambient Temperatures

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Tech Note:

Stability of GMP Cytokines after Reconstitution 

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Datasheet

CellGenix GMP Recombinant Human Interleukin-10 (rh IL-10)
en 438.9 kB

Safety Datasheet

Safety Datasheet: CellGenix® Recombinant Human IL-10
en 216.9 kB

Applications

  • Application
    Clinical ex vivo use (small)
  • Application Area
    • Cell & Gene Therapy
    • Immunology
    • Neuroscience
  • Cell Type
    DC

Biological Information

  • Activity
    3 – 50 x 106 IU/mg

Compliance Information

  • GMP Compliance
    This product was manufactured in conformance with established Current Good Manufacturing Practice (cGMP) standards.
  • Origin
    Animal-Component Free

Physicochemical Information

  • Endotoxin
    ≤ 50 EU/mg
  • Expression
    E. coli
  • Formulation
    Lyophilized from 200µl of 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

  • Brand
    CellGenix®
  • Package Type
    Vial

Sterility

  • Delivery Condition
    Sterile
  • Purity
    ≥ 97%

Volumes

  • Volume
    50 µg

Weights

  • Molecular Weight (kDa)
    19.6 kDa