Recombinant Human Thrombopoietin/TPO GMP Protein, CF GMP Best Seller

R&D Systems, part of Bio-Techne | Catalog # BT-TPO-GMP

R&D Systems, part of Bio-Techne
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BT-TPO-GMP-01M
BT-TPO-GMP-050
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Key Product Details

  • TPO Manufactured in Bio-Techne's new GMP facility
  • Lot-to-lot consistency
  • Stringent guidelines for patient safety
  • Scalability necessary to support successful therapeutics
  • Learn more about manufacturing in our new GMP facility
  • Test it in your process! Request a sample of GMP TPO

Source

E. coli

Accession #

NP_000451.1

Conjugate

Unconjugated

Applications

Bioactivity

View all Thrombopoietin/Tpo Proteins and Enzymes »

Product Specifications

Source

E. coli-derived human Thrombopoietin/Tpo protein
Ser22 - Leu195 with an N-terminal Alanine
Produced using non-animal reagents in an animal-free laboratory.Manufactured and tested under cGMP guidelines.

Purity

>95%, by SDS-PAGE with quantitative densitometry by Coomassie® Blue Staining. 18732 Da ± 50 Da

Endotoxin Level

<0.10 EU per 1 μg of the protein by the LAL method.

N-terminal Sequence Analysis

Ala-Ser22-Pro-Ala-Pro-Pro-Ala-(Cys)-Asp-Leu

Predicted Molecular Mass

18.7 kDa

SDS-PAGE

18-19 kDa, under reducing conditions.

Activity

Measured in a cell proliferation assay using MO7e human megakaryocytic leukemic cells. Avanzi, G. et al. (1988) Br. J. Haematol. 69:359.
The ED50 for this effect is 0.0500-0.500 ng/mL.  

The specific activity of Recombinant Human Thrombopoietin is >1.00 x 107 units/mg, which is calibrated against the Human Thrombopoietin reference standard (NIBSC code: 03/124).

Host Cell Protein

<5.00 ng per μg of protein when tested by ELISA.

Mycoplasma

Negative for Mycoplasma

Host Cell DNA

<0.00150 ng per µg of protein when tested by PCR.

Scientific Data Images for Recombinant Human Thrombopoietin/TPO GMP Protein, CF

Recombinant Human Thrombopoietin/Tpo GMP Protein Bioactivity.

The bioactivity of Recombinant Human Thrombopoietin/Tpo GMP Protein (Catalog # BT-TPO-GMP) was measured in a cell proliferation assay using MO7e human megakaryocytic leukemic cells. The ED50 for this effect is 0.0500‑0.500 ng/mL. Three independent lots were tested for bioactivity and plotted on the same graph to show lot-to-lot consistency of GMP Thrombopoietin/Tpo protein.

Equivalent Bioactivity of GMP and Animal-Free grades of Recombinant Human Thrombopoietin/TPO.

Equivalent bioactivity of GMP (Catalog # BT-TPO-GMP) and Animal-Free (BT-TPO-AFL) grades of Recombinant Human Thrombopoietin/TPO as measured in a cell proliferation assay using MO7e human megakaryocytic leukemic cells (orange and green, respectively).

Recombinant Human Thrombopoietin/Tpo GMP Protein SDS-PAGE.

2 μg/lane of Recombinant Human Thrombopoietin/Tpo GMP Protein (Catalog # BT-TPO-GMP) was resolved with SDS-PAGE under reducing (R) and non-reducing (NR) conditions and visualized by Coomassie® Blue staining, showing bands at 18-19 kDa under reducing conditions.
View 2 more images

Formulation, Preparation and Storage

BT-TPO-GMP
Formulation Lyophilized from a 0.2 μm filtered solution in Acetonitrile and TFA with Trehalose.
Reconstitution Reconstitute at 500 μg/mL in sterile water.
Shipping The product is shipped with polar packs. Upon receipt, store it immediately at the temperature recommended below.
Stability & Storage Use a manual defrost freezer and avoid repeated freeze-thaw cycles.
  • A minimum of 12 months when stored at ≤ -20 °C as supplied. Refer to lot specific COA for the Use by Date.
  • 1 month, 2 to 8 °C under sterile conditions after reconstitution.
  • 3 months, ≤ -20 °C under sterile conditions after reconstitution.

Background: Thrombopoietin/Tpo

Thrombopoietin (TPO) is a crucial regulator of hematopoietic stem cell (HSC) differentiation, maturation, and proliferation, as well as megakaryocytopoiesis and thrombopoiesis. TPO is often used in conjunction with Stem Cell Factor (SCF) and Flt-3 ligand in cell culture protocols to expand HSCs for bone marrow transplantation and cellular therapies. When combined with SCF and Flt-3 ligand, it promotes the differentiation of HSCs into megakaryocytes, leading to the production of platelets. It has shown promise in emerging cellular therapies for treating sickle cell disease, beta thalassemia, and other blood-related disorders. Moreover, TPO in combination with other cytokines is utilized in the generation of iNK cells, which have the potential to be incorporated into cellular immunotherapies.

Alternate Names

MGDF, MK-CSF, MKCSF, MPLLG, THCYT1, THPO, Tpo

Entrez Gene IDs

7066 (Human); 21832 (Mouse); 81811 (Rat)

Gene Symbol

THPO

UniProt

NP_000451.1

Additional Thrombopoietin/Tpo Products

Product Documents for Recombinant Human Thrombopoietin/TPO GMP Protein, CF

Product Datasheets

Certificate of Analysis

To download a Certificate of Analysis, please enter a lot number in the search box below.

Note: Certificate of Analysis not available for kit components.

Manufacturing Specifications

GMP Proteins
R&D Systems, a Bio-Techne Brand's GMP proteins are produced according to relevant sections of the following documents: USP Chapter 1043, Ancillary Materials for Cell, Gene and Tissue-Engineered Products and Eu. Ph. 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products.

R&D Systems' quality focus includes:

  • Designed, manufactured and tested under an ISO 9001:2015 and ISO 13485:2016 certified quality system
  • Documented and controlled manufacturing process
  • Control of documentation and process changes by QA
  • Personnel training programs
  • Raw material inspection and vendor qualification/monitoring program
  • Validated equipment, processes and test methods
  • Equipment calibration and maintenance schedules using a Regulatory Asset Manager
  • Facility/Utilities maintenance, contamination controls, safety and pest control programs
  • Material review process for variances
  • Robust product stability program following relevant ICH guidelines

R&D Systems strives to provide our customers with the analytical characteristics of each product so that customers may determine whether our products are appropriate for their application. Each product is provided with a lot-specific Certificate of Analysis that contains the product's specifications and test results. Quality control testing may include, but is not limited to:

  • N-terminal amino acid analysis
  • SDS-PAGE purity analysis
  • Molecular weight analysis via mass spectrometry
  • Endotoxin assessment per USP <85> and Ph. Eur. 2.6.14 guidelines
  • Bioassay analysis
  • Microbial testing per USP <71> and Ph. Eur. 2.6.1 guidelines
  • Host cell protein assessment
  • Host cell DNA assessment
  • Mycoplasma assessment

Additional testing and documentation requested by the customer can be arranged at an additional cost. 

Production records and facilities are available for examination by appropriate personnel on-site at R&D Systems in Minneapolis and St. Paul, Minnesota USA.

R&D Systems sells GMP grade products for preclinical or clinical ex vivo use. They are not for in vivo use. Please read the following End User Terms prior to using this product.


Animal-Free Manufacturing Conditions
Our dedicated controlled-access animal-free laboratories ensure that at no point in production are the products exposed to potential contamination by animal components or byproducts. Every stage of manufacturing is conducted in compliance with R&D Systems' stringent Standard Operating Procedures (SOPs). Production and purification procedures use equipment and media that are confirmed animal-free.

Production

  • All molecular biology procedures use animal-free media and dedicated labware.
  • Dedicated fermentors are utilized in committed animal-free areas.

Purification

  • Protein purification columns are animal-free.
  • Bulk proteins are filtered using animal-free filters.
  • Purified proteins are stored in animal-free containers.

    Please read our complete Animal-Free Statement

    Product Specific Notices for Recombinant Human Thrombopoietin/TPO GMP Protein, CF

    Full terms and conditions of sale can be found online in the Protein Sciences Segment T&Cs at: Terms & Conditions.

    For preclinical, or clinical ex vivo use

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