CellGenix® rh IL-3 (GMP Grade)

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CellGenix® rh IL-3 (GMP Grade) CellGenix® rh IL-3 (GMP Grade)
 

Top Features for Recombinant Human Interleukin-3:

  • Optimal use for expansion of HSCs
  • 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

Size
Quality Grade
Item No.: 
1002-050
Availability: 

*Custom/bulk order quotes are provided within 72 hours of request.

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CellGenix® Recombinant Human Interleukin-3 (IL-3) is an animal-derived component-free product. It is produced in a dedicated animal-free GMP facility. IL-3 is used in the cell and gene therapy space for the ex vivo expansion of hematopoietic stem cells (HSCs).

GMP grade: CellGenix® Recombinant Human IL-3 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.

Applications

  • Application
    Clinical ex vivo use (small)
  • Application Area
    • Cell & gene therapy
    • Immunology
  • Cell Type
    HSC
  • Intended Use
    For further manufacturing use

Biological Information

  • Activity
    0.9 – 3.6 x 106 IU/mg

Compliance Information

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

Features

  • Carrier-Protein Free
    Yes

Physicochemical Information

  • Endotoxin
    ≤ 0.05 EU/µg
  • Expression System
    E. coli
  • Formulation
    Lyophilized from 200 µL of a 0.2 µm-filtered solution containing 10 mM sodium phosphate and 50 mM sodium chloride, pH 7.2

Product Information

  • Brand
    CellGenix®
  • Package Type
    Vial
  • Size
    50 µg

Sterility/Purity

  • Delivery Condition
    Sterile
  • Purity
    ≥ 97%

Weight

  • Molecular Weight (kDa)
    15.2 kDa