Thrombopoietin (TPO) is a key regulator of megakaryocytopoiesis and thrombopoiesis. The human TPO precursor consists of 353 amino acids and is cleaved to yield a 332-amino-acid mature protein. Mature human TPO shares approximately 70% amino acid sequence homology with mouse and rat TPO. TPO and its receptor (c-Mpl) are the primary regulators of megakaryocyte and platelet production, playing a critical and indispensable role in hematopoietic stem cell (HSC) biology. TPO exerts its effects through the Jak-STAT, Ras-Raf-MAPK, and PI3K signaling pathways, promoting the survival, proliferation, and polyploidization of megakaryocytes. TPO is a megakaryocyte lineage-specific growth factor. In in vitro culture systems, the addition of recombinant human TPO can induce the differentiation of CD34+ hematopoietic stem cells into megakaryocytes and promote the maturation of polyploid megakaryocytes and platelet release. TPO protein can be used to study the regulation of megakaryocyte development, the molecular mechanisms of thrombopoiesis, and to screen for platelet-promoting drugs. TPO is commonly used in combination with cytokines such as SCF and FLT3-L for the in vitro expansion of hematopoietic stem cells and progenitor cells.

Product Information

Specifications

Feature

• High Purity: > 95%, avoiding immune reactions caused by host protein (HCP) or DNA residue.
• Ultra-low Endotoxin: < 10 EU/mg, reducing the risk of fever or inflammation.
• Batch-to-Batch Consistency: Ensuring stability and reproducibility in cell culture.
• Regulatory Compliance: Meeting regulatory requirements for cell therapy products, supporting IND filing.
• Animal-free: Free from animal viruses, pathogenic substances, and exogenous factor contamination, with high safety.

Regulatory Compliance Guidelines

The production and quality control of GMP-grade proteins comply with the following systems and procedures:

1. Complies with the General Requirements of Part III of the Pharmacopoeia of the People's Republic of China (2020 Edition): Quality Control of Raw Materials and Excipients for Biological Products.

2. Complies with USP Chapter <92> Growth Factors and Cytokines Used in Cell Therapy Manufacturing.

3. Complies with Ph. Eur. General Chapter 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products.

Quality Management System

1. GMP proteins are produced, tested, and released under a quality management system certified to ISO 13485:2016, ensuring batch-to-batch consistency and material traceability.

2. Certificate of Analysis (COA) provided.

3. Animal-free materials and production environment.

4. Pharmaceutical product raw and auxiliary material production facility.

5. Online/offline audit supported.

Product Safety Quality Control System

Endotoxin: < 10 EU/mg

Residual Host DNA: < 20 ng/mg

Residual Host Protein: < 0.5 ng/ug

Sterility Test: Negative

Mycoplasma Test: Negative

Exogenous Virus Test: Negative

Figure

SDS-PAGE

Figure 1: The purity is greater than 95% as determined by SDS-PAGE under reduced condition.

Bioactivity

Figure 2: The ED50 as determined by a cell proliferation assay using human M07e cells is less than 10 ng/mL.

Storage

Store at -25 to -15°C for 3 years. After reconstitution, store at -85 to -65°C for 3 months.

Documents:

Safety Data Sheet

92363_MSDS_HB260819

Manuals:

92363_Manual_HB20260818