CellGenix® rh TGF-β1

GMP and Preclinical grade

CellGenix Recombinant Human TGF-β1 reliably promotes the expansion of induced pluripotent stem cells (iPSC), embryonic stem cells (ESC), mesenchymal stem cells (MSC) as well as regulatory T cells (Tregs). It also stimulates the differentiation of T cells into Tregs.

General Information

Transforming Growth Factor-beta 1 (TGF-β1) is a member of the growth factor beta superfamily and plays a role in various cellular functions like cell differentiation, proliferation and apoptosis. It is secreted by most immune cells and especially interacts with T cells, B cells, macrophages and monocytes.

TGF-β1 is used in the cell and gene therapy space to promote expansion of iPSC, ESC, MSC and Tregs.

CellGenix Recombinant Human TGF-β1 is produced using a human amniocyte cell line (CAP®). By using the CAP® technology we are able to produce this difficult to express glyco-protein with authentic human post-translational modifications. These human post-translational modifications are not accessible by bacterial expression.

GMP Grade

CellGenix GMP Recombinant Human TGF-β1 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.

name
CellGenix® Recombinant Human Transforming Growth Factor-beta 1
Source
CAP® cell line
Formulation
Lyophilized
ANIMAL-DERIVED COMPONENT-FREE
CellGenix® GMP rh TGF-β1
amount
Order Number
50  µg
1026-050
CellGenix® Preclinical rh TGF-β1
amount
Order Number
50  µg
1426-050

CellGenix® rh TGF-β1

Features

  • Native folding & glycosylation: expressed in human CAP® cells
  • Safe and ADCF: CAP® cell line extensively characterized and tested for viruses
  • Global compliance: USP <1043>, Ph. Eur. 5.2.12, ISO TS 20399

GMP & Preclinical Grade

  • Seamless transition from preclinical development to ATMP manufacturing

Applications

  • Differentiation of T cells into Tregs
  • Expansion of ESCs, iPSCs, MSCs and Tregs

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 CAP® cell line
Description

Human Transforming Growth Factor-beta 1, accession # PO1137, Ala279-Ser390

Formulation

Lyophilized from a 0.2 µm-filtered solution containing 1% Mannitol

The production cell line was derived from an extensively characterized human amniocyte cell line (CAP®).
CAP® is a registered trademark of CEVEC Pharmaceuticals GmbH, Germany.

 PreclinicalGMP
Starting Material

CAP® MCB characterized according to ICH Guidelines Q5A and Q5D
Biologics Master File (BB-MF) for the originating CAP® cell bank available

CAP® MCB characterized according to ICH Guidelines Q5A and Q5D
Biologics Master File (BB-MF) for the originating CAP® cell bank available

Molecular weight25.6 kDa per homodimer25.6 kDa per homodimer
Purity≥ 95% as determined by SDS-PAGE≥ 97% as determined by SDS-PAGE
Activity

≥ 9 x 106 IU/mg, calibrated against NIBSC #89/514
Measured in a cell proliferation assay using a TGF-β1-dependent cell line, HT2 clone A5E

 

≥ 9 – 36 x 106 IU/mg, calibrated against NIBSC #89/514
Measured in a cell proliferation assay using a TGF-β1-dependent cell line, HT2 clone A5E

Batch specific activity on CoA

Endotoxin level≤ 10 EU/mg≤ 10 EU/mg
Intended useIntended for preclinical ex vivo use. Not intended for therapeutic use.For further manufacturing use.

 

Handling Instructions

Reconstitution

Recommended in sterile water to a final concentration of 250 µg/ml.

Shipment

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

Expiry

Please refer to Certificate of Analysis for the exact expiry date.

Storage & Stability

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

Avoid repeated freeze/thaw cycles.

Documents

Data

CellGenix GMP rh TGF-β1 has an activity of 9 – 36 x 106 IU/mg

The activity of GMP rh TGF-β1 was measured in a cell proliferation assay using the TGF-dependent cell line HT2-clone A5E. It was calibrated against the WHO International Standard NIBSC #89/514.

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