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CellGenix/CellGenix® rh IL-2/1mg in 1ml/1520-1000

Technical Details

Source
Expressed in E. coli
Description

Human IL-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

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-28 – 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 Sheet: GMP, Preclinical or GMP-Prototype, Syringe
  • Material Safety Data Sheet: MSDS
  • Certificate of Analysis
  • Technote: ADCF and Serum-free Policy
  • Technote: Batch-to-Batch Consistency of CellGenix® GMP Cytokines
  • Technote: Stability of CellGenix® GMP Cytokines after Reconstitution
  • Technote: Shipment of CellGenix® Preclinical and GMP Cytokines at Ambient Temperatures
  • Technote: CellGenix® rh Cytokines - Preclinical vs GMP
  • More information under Resources

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

  • TSE certificate (available on request)
  • Regulatory Support File (available on request)
  • Request a DMF Letter of Authorization (USA only)

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®.

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.

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