Recombinant Human Thrombopoietin GMP Protein, CF

Recombinant Human Thrombopoietin GMP Protein, CF Summary

Product Specifications

Product Datasheets

Carrier Free

CF stands for Carrier Free (CF). We typically add Bovine Serum Albumin (BSA) as a carrier protein to our recombinant proteins. Adding a carrier protein enhances protein stability, increases shelf-life, and allows the recombinant protein to be stored at a more dilute concentration. The carrier free version does not contain BSA.

In general, we advise purchasing the recombinant protein with BSA for use in cell or tissue culture, or as an ELISA standard. In contrast, the carrier free protein is recommended for applications, in which the presence of BSA could interfere.

Background: Thrombopoietin/Tpo

Thrombopoietin (Tpo), is a key regulator of megakaryocytopoiesis and thrombopoiesis. It is principally produced in the liver and is bound and internalized by the receptor Tpo R/c-mpl. Defects in the Tpo-Tpo R signaling pathway are associated with a variety of platelet disorders (1-3). The 353 amino acid (aa) human Tpo precursor is cleaved to yield the 332 aa mature protein. Mature human Tpo shares approximately 70% aa sequence homology with mouse and rat Tpo. It is an 80‑85 kDa protein that consists of an N‑terminal domain with homology to Erythropoietin (Epo) and a C‑terminal domain that contains multiple N‑linked and O-linked glycosylation sites (4, 5). Tissue specific alternate splicing of human Tpo generates multiple isoforms with internal deletions, insertions, and/or C‑terminal substitutions (6). Tpo promotes the differentiation, proliferation, and maturation of MK and their progenitors (4, 5, 7). Several other cytokines can promote these functions as well but only in cooperation with Tpo (8, 9). Notably, IL-3 independently induces MK development, although its effects are restricted to early in the MK lineage (8, 9). Tpo additionally promotes platelet production, aggregation, ECM adhesion, and activation (10-13). It is cleaved by platelet-derived thrombin following Arg191 within the C‑terminal domain and subsequently at other sites upon extended digestion (14). Both full length Tpo and shorter forms circulate in the plasma, with the shorter, N‑terminal EPO-like domain forms showing significantly increased specific activity (4, 5, 15). The C‑terminal domain is not required for binding to Tpo R or inducing MK growth and differentiation (5). Aside from its hematopoietic effects, Tpo is expressed in the brain where it promotes the apoptosis of hypoxia-sensitized neurons and inhibits neuronal differentiation by blocking NGF induced signaling (16, 17).

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

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

Related Research Areas

• Megakaryocytes
• Myeloid Lineage Markers
• Osteoblast and Osteoclast Markers
• Osteogenesis Markers
• Osteoprogenitor Markers