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 CAR T cells, TCR T cells, Tregs, TILs, 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>, Ph. Eur. General Chapter 5.2.12 and ISO Technical Standard 20399.

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.

 

IL-2 Syringe

Our proven CellGenix® GMP rh IL-2 is now available in a liquid format. The single-use syringe is easy to use. It will save you time and avoids handling mistakes – which is especially valuable in a cell therapy manufacturing environment.

You can find more detailed information about the IL-2 syringe in the syringe tab below.

name
CellGenix® Recombinant Human Interleukin-2
Source
E. coli
Formulation
Lyophilized / in solution
ANIMAL-DERIVED COMPONENT-FREE
CellGenix® GMP rh IL-2
amount
Order Number
1 mg
1020-1000-1
50  µg
1020-050-1
CellGenix® Preclinical rh IL-2
amount
Order Number
50  µg
1420-050-1
CellGenix® GMP-Prototype rh IL-2, Syringe
amount
Order Number
1mg in 1ml
1520-1000

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)
  • Available in different formats (lyophilized & liquid)

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 and costs 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®
Measured in a cell proliferation assay using an IL-2-dependent cell line, CTLL-2
8 – 32 x 106 IU/mg, calibrated against Proleukin®
Measured in a cell proliferation assay using an IL-2-dependent cell line, CTLL-2

Batch specific activity on CoA

Endotoxin level< 25 EU/mg≤ 25 EU/mg
Intended useIntended for preclinical ex vivo use. Not intended for therapeutic use.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 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).

Regulatory Support

We offer the following to assist you with your regulatory approval process:

  • Comprehensive documentation (e.g. DMFs, Regulatory Support Files, Certificates of Origin)
  • Outstanding QC support (e.g. extensive stability data)
  • The possibility to audit our production site
  • Detailed batch specific test results on our Certificates of Analysis
  • Change notifications prior to relevant changes

Customized solutions can be provided to meet special compliance needs. Contact our Regulatory Support Team for all your regulatory requests & questions:

Phone:     +49 761 88 88 9-302
Email:      regulatorysupport@cellgenix.com

 

In order to stay up-to-date and help improve regulatory guidance we are actively involved in many of the regulatory initiatives and discussions. We were amongst others actively involved in the discussions for the setup of Ph. Eur. General Chapter 5.2.12 and the ISO Technical Standard 20399.

 

Regulatory Resources

GMP-Prototype rh IL-2, Syringe

 

SourceExpressed in E. coli
Description

Human Interleukin-2 with a substitution of Cysteine-125 by Serine, accession # P60568, Pro22-Thr153, N-terminal Met and C-terminal 6xHis-tag, molecular mass 16.3 kDa.

With the exception of the added C-terminal 6xHis-tag, the amino acid sequence corresponds to that of Aldesleukin.

Formulation

0.2 µm-filtered aqueous solution containing 25 mM sodium acetate and 50 mM sodium chloride, pH 5.0.

The formulation is identical to CellGenix® GMP rh IL-2 (order No 1020-050/1020-1000) before lyophilization.

Molecular weight16.3 kDa
Purity≥ 97% as determined by SDS-PAGE and RP-HPLC
Activity8 – 32 x 106 IU/mg, calibrated against internal reference standard1
Measured in a cell proliferation assay using an IL-2-dependent cell line, CTLL-2

Batch specific activity on CoA

Endotoxin level≤ 25 EU/mg
Intended useFor preclinical ex vivo use. Not intended for human in vivo application.

1The internal reference standard was calibrated against Proleukin®.

 

GMP-Prototype

We innitialy offer our IL-2 syringe as GMP-prototype. This allows you to test the IL-2 syringe before our GMP grade will be available. We are currently generating supplementary quality control data, including extended real-time stability data, in order to meet our GMP quality standards. The performance and product characteristics are identical to the future GMP rh IL-2 syringe, allowing for a seamless transition to GMP.

 

Handling Instructions

Insert the plunger into the barrel of the glass syringe by gently screwing the plunger clockwise into the elastomeric stopper. Remove the tamper evident tip cap by twisting. They syringe is now ready for use.

NOTICE: this is a single-use solution.

 

Shipment & Storage

  • Transport at +2°C to +8°C.
  • Store at +2°C to +8°C directly upon arrival.

NOTICE: do not freeze product in its original container to maintain integrity.