Recombinant Human IL-2 

Activate and Expand T Cells, NK Cells and CIK Cells With High Cell Yield and Desired Phenotypes

CellGenix® Recombinant Human Interleukin-2 (IL-2) is a xeno-free and animal-derived component-free product. It reliably promotes proliferation and differentiation of CAR T cells, T cells, TCR T cells, Tregs, TILS, natural killer cells (NK cells), and cytokine-induced killer cells (CIK cells). CellGenix® rh IL-2 is produced in a dedicated animal-free GMP facility.​

About Recombinant Human IL-2

Characteristics
  • Activity: ≥ 8 x 10IU/mg
  • Origin: Animal-derived component free (ADCF) level 2
  • Purity: ≥ 95%

  • Endotoxin: < 25 EU/mg

  • Source: E. coli

  • Formulation: Lyophilized
  • Preclinical IL-2
Advantages
  • Produced in our dedicated animal-free GMP facility enhancing safety for optimal use in ATMP manufacturing
  • Seamless transition when switching to GMP production
  • Proven high activity levels enabling cost-efficient production
Quality Standards
  • High lot-to-lot consistency – save time and costs on revalidations
  • Performance reliability – get reliable product performance
  • High purity – ensure the safety of your ATMP
  • Extremely low endotoxin levels – improve safety and reproducibility
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Source: 

Expressed in E. coli

Biological Information: 

Human IL-2 with a substitution of cysteine-125 by serine, accession # P60568, Pro22-Thr153, N-terminal Met and C-terminal 6xHis-tag

With the exception of the added C-terminal 6xHis-tag, the amino acid sequence corresponds to that of pharma-grade IL-2

Formulation: 

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

Molecular weight

16.3 kDa

Purity

≥ 95% as determined by SDS-PAGE and HPLC

Activity≥ 8 x 106 IU/mg, calibrated against pharma-grade IL-2
Measured in a cell proliferation assay using an IL-2-dependent cell line, CTLL-2
Endotoxin level

< 25 EU/mg

Intended useIntended for preclinical ex vivo use. Not intended for clinical use.

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. 

Expiry

3 years from date of shipping.

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.

Tech Notes

Designed to meet the demands of translational research, our ‘preclinical grade’ cytokines are ideal to allow for a seamless transition from preclinical development to the clinical stage. CellGenix® preclinical and GMP cytokines are produced under the same conditions in a GMP facility, using identical production steps and expression systems. This ensures an equal product quality and performance.​

The difference between both quality levels is that we offer a more comprehensive QC testing including tighter specifications and documentation for our GMP products. Our preclinical grade products therefore offer a cost-efficient alternative for the early development phase when safety and quality of ancillary materials have a lower priority.

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Quality Attributes

Preclinical Grade

GMP Grade

Sterility testing

Yes

Ph. Eur.

Purity

≥ 95%

≥ 97%

Endotoxin testing (all cytokines except IL-2, IL-7, IL-15, IL-21 and TGF-β1)

< 1000 EU/mg

≤ 50 EU/mg

Endotoxin testing (IL-2, IL-7, IL-15 and IL-21)

< 25 EU/mg

≤ 25 EU/mg

Endotoxin testing (TGF-β1)

< 25 EU/mg

≤ 10 EU/mg

Sartorius CellGenix® is the only supplier with a preclinical grade that can be replaced directly with the corresponding product at GMP grade in clinical and commercial manufacturing use.​

Quality and consistency of critical ancillary materials are directly linked to the clinical and commercial success of a therapy. Several years of proven batch-to-batch consistency across the preclinical and GMP cytokines range demonstrate the high quality, safety and reliability of CellGenix® cytokines.

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Ancillary materials derived from biological origin can introduce risks to the process and final ATMP product, including transmission of viruses.​

Using animal-derived component-free cytokines​:

  • Ensures maximum safety of the ATMP, no animal or human-derived components are part of any of our cytokine products. ​
  • Reduces variables associated with animal-derived components.​
  • Makes time-consuming and expensive viral safety studies obsolete, thereby bringing a significant economic benefit.​

The large majority of our cytokines is produced in a dedicated animal-free facility (ADCF Level 2). These cytokines have never been exposed to animal components or byproducts.​

Very few cytokines produced in the segregated animal-derived components (ADC) production area require either the use of ADC in the production process or a human expression system to allow proper functional expression (ADCF Level 1). To ensure maximum safety we provide documented evidence of viral and prion safety.​

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CellGenix® cytokines are lyophilized, making them stable at a wide range of temperatures. The products are delivered in our standard packaging at ambient temperatures.

To ensure that the product quality is not compromised during shipment at ambient temperatures we have put a validated shipment procedure in place. As part of this procedure, we implemented special temperature control measures and performed shipment stability studies.

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