CellGenix® rh IL-6

GMP and Preclinical grade

CellGenix® Recombinant Human IL-6 reliably stimulates the maturation of immature to mature dendritic cells (DCs) in combination with CellGenix® GMP DC Medium and promotes the proliferation of cord blood derived hematopoietic stem cells (HSCs/CD133+ cells) in combination with CellGenix® GMP SCGM Medium. It is produced in our dedicated animal-free GMP facility ensuring maximum safety for optimal use in ATMP manufacturing.

GMP Grade

CellGenix® Recombinant Human IL-6 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.

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.

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.

Name
CellGenix® Recombinant Human Interleukin-6
Source
E. coli
Formulation
Lyophilized
ANIMAL-DERIVED COMPONENT-FREE
CellGenix® GMP rh IL-6
amount
Order Number
1 mg
1004-1000
50  µg
1004-050
CellGenix® Preclinical rh IL-6
amount
Order Number
50  µg
1404-050

CellGenix® rh IL-6

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

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

Applications

Interleukin-6 (IL-6) is a multifunctional cytokine that acts both pro-inflammatory and anti-inflammatory. It regulates acute phase responses, inflammatory reactions, hematopoiesis, bone metabolism, cancer progression and immune responses. It is produced primarily by T cells, monocytes and macrophages.

IL-6 is used in the cell and gene therapy space for the ex vivo maturation of immature DCs and proliferation of HSCs.

Technical Details

Source
Expressed in E. coli
Description

Human IL-6, accession # P05231, Pro29-Met212

Formulation

Lyophilized from a 0.2 µm-filtered solution containing 1.5 mM potassium phosphate, 8.1 mM sodium phosphate, 2.7 mM potassium chloride and 137 mM sodium chloride, pH 7.5

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.

  Preclinical GMP
Molecular weight 21.9 kDa 21.9 kDa
Purity ≥ 95% as determined by SDS-PAGE ≥ 97% as determined by SDS-PAGE
Activity ≥ 80 x 106 IU/mg, calibrated against NIBSC #89/548
Measured in a cell proliferation assay using an IL-6-dependent cell line, B9
80 – 250 x 106 IU/mg, calibrated against NIBSC #89/548
Measured in a cell proliferation assay using an IL-6-dependent cell line, B9

 

Batch specific activity on CoA

Endotoxin level < 1000 EU/mg ≤ 50 EU/mg
Intended use Intended 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 sterile water to a final concentration of 250 µg/ml for 50 µg vials and for 1 mg vials. We recommend to not vortex the solution. The solution can be turbid, this however does not influence the activity. 

Shipment

Ambient temperature. Please refer to our Technote Shipment of CellGenix® preclinical and GMP cytokines at ambient temperatures.

Expiry

GMP: ≥ 6 months from date of shipping
Preclinical: 3 years 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 100 µg/ml reconstituted cytokine solution:

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

Store a 250 µg/ml reconstituted cytokine solution:

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

Avoid repeated freeze/thaw cycles.

Documents

Data

CellGenix® GMP rh IL-6 has an activity of 80 – 250 × 106 IU/mg

The activity of GMP rh IL-6 was measured in a cell proliferation assay using the IL-6-dependent cell line B9. It was calibrated against the NIBSC #89/548.

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

IL6, Interleukin6

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