Product Specifications
Source
E. coli-derived human IL-3 protein
Ala20-Phe152, with and without an N-terminal Met
Produced using non-animal reagents in an animal-free laboratory.
Manufactured and tested under cGMP guidelines.
Purity
>97%, by SDS-PAGE under reducing conditions and visualized by silver stain.
Endotoxin Level
<0.10 EU per 1 μg of the protein by the LAL method.
N-terminal Sequence Analysis
Met-Ala-Pro-Met-Thr-Gln-Thr-Thr-Ser-Leu
Ala-Pro-Met-Thr-Gln-Thr-Thr-Ser-Leu-Lys
Predicted Molecular Mass
15 kDa
Activity
Measured in a cell proliferation assay using TF‑1 human erythroleukemic cells. Kitamura, T. et al. (1989) J. Cell Physiol. 140:323.
The ED50 for this effect is 0.02-0.1 ng/mL.
The specific activity of recombinant human IL-3 is >1.7 x 106 IU/mg, which is calibrated against the human IL-3 WHO International Standard (NIBSC code: 91/510).
Host Cell Protein
0.5 ng per µg of protein when tested by ELISA.
Mycoplasma
Negative for Mycoplasma.
Host Cell DNA
< 0.0010 ng per µg of protein when tested by PCR.
Background: IL-3
Interleukin 3 is a pleiotropic factor produced primarily by activated T cells that can stimulate the proliferation and differentiation of pluripotent hematopoietic stem cells as well as various lineage committed progenitors. In addition, IL-3 also affects the functional activity of mature mast cells, basophils, eosinophils and macrophages. Because of its multiple functions and targets, it was originally studied under different names, including mast cell growth factor, P-cell stimulating factor, burst promoting activity, multi-colony stimulating factor, thy-1 inducing factor and WEHI-3 growth factor. In addition to activated T cells, other cell types such as human thymic epithelial cells, activated murine mast cells, murine keratinocytes and neurons/astrocytes can also produce IL-3. At the amino acid sequence level, mature human and murine IL-3 share only 29% sequence identity. Consistent with this lack of homology, IL-3 activity is highly species-specific and human IL-3 does not show activity on murine cells.
IL-3 exerts its biological activities through binding to specific cell surface receptors. The high affinity receptor responsible for IL-3 signaling is composed of at least two subunits, an IL-3 specific alpha chain which binds IL-3 with low affinity and a common beta chain that is shared by the IL-5 and GM-CSF high-affinity receptors. Although the beta chain itself does not bind IL-3, it confers high-affinity IL-3 binding in the presence of the alpha chain. Receptors for IL-3 are present on bone marrow progenitors, macrophages, mast cells, eosinophils, megakaryocytes, basophils and various myeloid leukemic cells.
Alternate Names
IL3, MCGF, MULTI-CSF
Additional IL-3 Products
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 IL-3 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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