name
CellGenix® Recombinant Human Thrombopoietin
Source
E. coli
Formulation
Lyophilized
ANIMAL-DERIVED COMPONENT-FREE
CellGenix® GMP rh TPO
amount
Order Number
1 mg
1017-1000
50  µg
1017-050
CellGenix® Preclinical rh TPO
amount
Order Number
50  µg
1417-050

CellGenix® rh TPO

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

Applications

  • Expansion of HSCs
  • Differentiation of HSCs into NK cells
  • Differentiation of ESCs and iPSCs into megakaryocytes

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

Truncated Human TPO, accession # P40225, Ser22-Leu195

Formulation

Lyophilized from a 0.2 µm-filtered aqueous solution

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 19.6 kDa 19.6 kDa
Purity ≥ 95% as determined by SDS-PAGE ≥ 98% as determined by SDS-PAGE
Activity ≥ 10 x 106 IU/mg, calibrated against an in-house reference standard
Measured in a cell proliferation assay using a TPO-dependent cell line, MO7e
10 – 40 x 106 IU/mg, calibrated against an in-house reference standard
Measured in a cell proliferation assay using a TPO-dependent cell line, MO7e

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 or 500 µg/ml for 1 mg vials.

Shipment

Ambient temperature. Please refer to our Technote Shipment of CellGenix® Preclinical and GMP Cytokines at Ambient Temperatures.

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 TPO has an activity of 10 – 40 × 106 IU/mg

The activity of GMP rh TPO was measured in a cell proliferation assay using the TPO-dependent cell line MO7e. It was calibrated against an in-house reference standard.

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 9-0
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 ISO 20399:2022.

 

Regulatory Resources

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

Publications

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