CellGenix® rh IL-2

GMP and Preclinical grade

CellGenix Recombinant Human IL-2 reliably activates and expands T cells, natural killer cells (NK cells) and cytokine-induced killer cells (CIK cells). CellGenix rh IL-2 is produced in our dedicated animal-free facility ensuring maximum safety for optimal use in ATMP manufacturing.

General Information

Interleukin-2 (IL-2) is a cytokine signaling molecule that is mainly produced by T cells. It is a central regulator of immune responses and plays a role in anti-inflammatory reactions, hematopoiesis and tumor surveillance.

IL-2 is used in the cell and gene therapy space to promote proliferation and differentiation of T cells, NK cells and CIK cells.

GMP Grade

CellGenix GMP Recombinant Human IL-2 is produced following all applicable GMP guidelines and allows for the safe use in accordance with USP Chapter <1043> and Ph. Eur. General Chapter 5.2.12.

Our 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.

name
CellGenix® Recombinant Human Interleukin-2
Source
E. coli
Formulation
Lyophilized
ANIMAL-DERIVED COMPONENT-FREE
CellGenix® GMP rh IL-2
amount
Order Number
50  µg
1020-050
1 mg
1020-1000
CellGenix® Preclinical rh IL-2
amount
Order Number
50  µg
1420-050

CellGenix® rh IL-2

Features

  • Produced in our dedicated animal-free facility
  • Compliant to USP Chapter <1043> and Ph. Eur. General Chapter 5.2.12 (GMP)
  • FDA Drug Master File available (GMP)

GMP & Preclinical Grade

  • Seamless transition from preclinical development to ATMP manufacturing

Applications

  • Activation and expansion of T cells, NK cells and CIK cells

Highest GMP Quality Standard

  • High lot-to-lot consistency – save time on revalidations
  • Performance reliability – rely on consistent product performance
  • Highest purity – ensure the safety of your ATMP
  • Extremely low endotoxin levels – improve safety and reproducibility
  • Expert regulatory & technical support – rely on experience

Read more about our GMP Quality

 

Safe │ GMP Compliant │ Reliable

Technical Details

Source
Expressed in E. coli
Description

Human IL-2 with a substitution of cysteine-125 by serine, accession # P60568, Pro22-Thr153

Formulation

Lyophilized from a 0.2 µm-filtered solution containing 25 mM sodium acetate and 50 mM sodium chloride, pH 5.0

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: Preclinical vs GMP

 PreclinicalGMP
Molecular weight16.3 kDa16.3 kDa
Purity≥ 95% as determined by SDS-PAGE and HPLC≥ 97% as determined by SDS-PAGE and HPLC
Activity≥ 8 x 106 IU/mg, calibrated against Proleukin®8 – 32 x 106 IU/mg, calibrated against Proleukin®
Batch specific activity on CoA
Endotoxin level< 25 EU/mg≤ 25 EU/mg
Intended useIntended for preclinical ex vivo use. Not intended for human in vivo application.Intended for clinical ex vivo use. Not intended for human in vivo application.

Handling Instructions

Reconstitution

Recommended in 0.2% acetic acid to a final concentration of 250 µg/ml for 50 µg vials or 500 µg/ml for 1 mg vials.

Shipment

Ambient temperature. Please refer to Technote to learn more about our shipment validation procedure.

Expiry

≥ 6 months from date of shipping. Please refer to Certificate of Analysis (CoA) for the exact expiry date.

Storage & Stability

Store lyophilized cytokine at -20°C to -80°C.

Store a 250 µg/ml reconstituted cytokine solution:

• 4 weeks at 2°C to 8°C under sterile conditions after reconstitution. Store in the original container. 

• 4 months at -20°C to -80°C under sterile conditions after reconstitution. Store in 60 µl aliquots in polypropylene cryogenic vials.

Avoid repeated freeze/thaw cycles.

Documents

Data

CellGenix GMP rh IL-2 has an activity of 8 – 32 × 106 IU/mg

The activity of GMP rh IL-2 was measured in a cell proliferation assay using the IL-2-dependent cell line CTLL-2. It was calibrated against Proleukin®.

You can find the batch specific activity on the certificate of analysis (CoA).

 

 

Publications