Recombinant Human IL-4 GMP Protein, CF GMP
R&D Systems, part of Bio-Techne | Catalog # BT-004-GMP
Key Product Details
- IL-4 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 IL-4
Product Specifications
Source
E. coli-derived human IL-4 protein
His25-Ser153, with an N-terminal Met
Produced using non-animal reagents in an animal-free laboratory.Manufactured and tested under cGMP guidelines.
His25-Ser153, with 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 with quantitative densitometry by Coomassie® Blue Staining.
Endotoxin Level
<0.10 EU per 1 μg of the protein by the LAL method.
N-terminal Sequence Analysis
Met-His25-Lys-(Cys)-Asp-Ile-Thr-Leu-Gln-Glu
Predicted Molecular Mass
15.1 kDa
SDS-PAGE
13 kDa, under reducing conditions.
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 0.0400-0.320 ng/mL.
The specific activity of GMP Recombinant Human IL-4 is >1.0x107 IU/mg, which is calibrated against the human IL-4 WHO International Standard (NIBSC code: 88/656).
Host Cell Protein
<0.100 ng per μg of protein when tested by ELISA.
Mycoplasma
Negative when tested in a ribosomal RNA hybridization assay.
Host Cell DNA
<0.00150 ng per µg of protein when tested by PCR.
Scientific Data Images for Recombinant Human IL-4 GMP Protein, CF
Recombinant Human IL-4 GMP Protein Bioactivity.
Recombinant Human IL-4 GMP Protein (Catalog # BT-004-GMP) as measured in a cell proliferation assay using TF-1 human erythroleukemic cells. Three independent lots were tested for activity and plotted on the same graph to show lot-to-lot consistency of Recombinant Human IL-4 GMP Protein.
Recombinant Human IL-4 Protein Bioactivity Comparison.
Equivalent bioactivity of GMP (BT-004-GMP) and Animal-Free (BT-004-AFL) grades of Recombinant Human IL-4 as measured in a cell proliferation assay using TF-1 human erythroleukemic cells (Green & Orange, respectively).
Recombinant Human IL‑4 GMP Protein SDS-PAGE.
2 μg/lane of Recombinant Human IL‑4 GMP Protein (Catalog # BT-004-GMP) was resolved with SDS-PAGE under reducing (R) and non-reducing (NR) conditions and visualized by Coomassie® Blue staining, showing bands at 13 kDa under reducing conditions.Formulation, Preparation and Storage
BT-004-GMP
| Formulation | Lyophilized from a 0.2 μm filtered solution in PBS with Trehalose. |
| Reconstitution | Reconstitute at 500 μg/mL in PBS. |
| 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.
|
Background: IL-4
Interleukin-4 (IL-4), also known as B cell-stimulatory factor-1, is a monomeric, approximately 13 kDa‑18 kDa Th2 cytokine that shows pleiotropic effects during immune responses (1‑3). It is a glycosylated polypeptide that contains three intrachain disulfide bridges and adopts a bundled four alpha-helix structure (4). Human IL-4 is synthesized with a 24 aa signal sequence. Alternate splicing generates an isoform with a 16 aa internal deletion. Mature human IL-4 shares 55%, 39% and 43% aa sequence identity with bovine, mouse, and rat IL-4, respectively. Human, mouse, and rat IL-4 are species-specific in their activities (5‑7). IL-4 exerts its effects through two receptor complexes (8, 9). The type I receptor, which is expressed on hematopoietic cells, is a heterodimer of the ligand binding IL-4 R alpha and the common gamma chain (a shared subunit of the receptors for IL-2, -7, -9, -15, and ‑21). The type II receptor on nonhematopoietic cells consists of IL-4 R alpha and IL‑13 R alpha1. The type II receptor also transduces IL-13 mediated signals. IL-4 is primarily expressed by Th2-biased CD4+ T cells, mast cells, basophils, and eosinophils (1, 2). It promotes cell proliferation, survival, and immunoglobulin class switch to IgG4 and IgE in human B cells, acquisition of the Th2 phenotype by naïve CD4+ T cells, priming and chemotaxis of mast cells, eosinophils, and basophils, and the proliferation and activation of epithelial cells (10‑13). IL-4 plays a dominant role in the development of allergic inflammation and asthma (12, 14).
Due to its role in the differentiation of certain immune cell types, IL-4 is commonly used in combination with other growth factors to transform induced pluripotent stem cells into dendritic cells in high numbers. These dendritic cells can then be used for research or clinical applications to improve disease modeling, for screening and cell therapies (15). Study of IL-4 signaling has led to the development of monoclonal antibodies that can block the signaling pathway at various steps to mitigate the inflammatory response in certain autoimmune diseases (16, 17). While IL-4 has the capacity to improve immune functions, treatments involving IL-4 have not been utilized due to the dangerous side effects that may result from IL-4 signaling in non-immune cells (16). Blockade of IL-4 signaling also has been studied as a therapeutic target to suppress inflammation in the tumor microenvironment (18). Use of IL-4 suppressors can also improve the efficacy of anti-tumor immunotherapies, as blocking IL-4 enhances activity of tumor-specific T lymphocytes (19, 20).
References
- Benczik, M. and S.L. Gaffen (2004) Immunol. Invest. 33:109.
- Chomarat, P. and J. Banchereau (1998) Int. Rev. Immunol. 17:1.
- Yokota, T. et al. (1986) Proc. Natl. Acad. Sci. 83:5894.
- Redfield, C. et al. (1991) Biochemistry 30:11029.
- Ramirez, F. et al. (1988) J. Immunol. Meth. 221:141.
- Leitenberg, D. and T.L. Feldbush (1988) Cell. Immunol. 111:451.
- Mosman, T.R. et al. (1987) J. Immunol. 138:1813.
- Mueller, T.D. et al. (2002) Biochim. Biophys. Acta 1592:237.
- Nelms, K. et al. (1999) Annu. Rev. Immunol. 17:701.
- Paludan, S.R. (1998) Scand. J. Immunol. 48:459.
- Corthay, A. (2006) Scand. J. Immunol. 64:93.
- Ryan, J.J. et al. (2007) Crit. Rev. Immunol. 27:15.
- Grone, A. (2002) Vet. Immunol. Immunopathol. 88:1.
- Rosenberg, H.F. et al. (2007) J. Allergy Clin. Immunol. 119:1303.
- Flosdorf, N. & Zenke, M. (2022) Eur. J. Immunol. 52:1880.
- Junttila, I.S. (2018) Front Immunol. 9:888.
- Keegan, A.D. et al. (2021) Fac Rev. 10:71.
- Bankaitis, K.V. & Fingleton, B. (2016) Clin. Exp. Metastasis. 32:847.
- Mirlekar, B. (2022) SAGE Open Med. 10:1.
- Ilto, S. E. et al. (2017) Cancer Immunol Immunother. 66:1485.
Long Name
Interleukin 4
Alternate Names
BCDF, BCGF-1, BCGF1, BSF-1, BSF1, IL4, IL4E12
Entrez Gene IDs
Gene Symbol
IL4
UniProt
Additional IL-4 Products
Product Documents for Recombinant Human IL-4 GMP Protein, CF
Manufacturing Specifications
GMP ProteinsR&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:
- Manufactured and tested under an ISO 9001:2015 and ISO 13485:2016 certified quality system
- Documented processes and QA control of documentation and process changes
- Personnel training programs
- Raw material testing and vendor qualification/monitoring
- Fully validated equipment, processes and test methods
- Equipment calibration schedules using a computerized calibration program
- Facility maintenance, safety programs and pest control
- Material review process for variances
- Monitoring of stability over product shelf-life
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 research. The Certificate of Analysis provided contains the following lot specific information:
- N-terminal amino acid analysis, SDS-PAGE analysis, and endotoxin level (as determined by LAL assay) performed on each bulk QC lot, not on individual bottlings of each QC lot
- Post-bottling lot-specific bioassay results (compliance with an established range) and results of microbial testing according to USP <71>
- Host Cell Protein testing performed by ELISA
- Mycoplasma testing by ribosomal RNA hybridization assay
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, 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.
- Protein purification columns are animal-free.
- Bulk proteins are filtered using animal-free filters.
- Purified proteins are stored in animal-free containers in a dedicated cold storage room.
Quality Assurance
- Low Endotoxin Level.
- No impairment of biological activity.
- High quality product obtained under stringent conditions.
Product Specific Notices for Recombinant Human IL-4 GMP Protein, CF
END USER TERMS OF USE OF PRODUCT
The following terms are offered to you upon your acceptance of these End User Terms of Use of Product. By using this product, you indicate your acknowledgment and agreement to these End User Terms of Use of Product. If you do not agree to be bound by and comply with all of the provisions of these End User Terms of Use of Product, you should contact your supplier of the product and make arrangements to return the product.
We suggest you print and retain a copy of these End User Terms of Use of Product for your records.
The End User is aware that R&D Systems, Inc. sells GMP products for preclinical or clinical ex vivo use and not for in vivo use. The End User further agrees, as a condition of the sale of R&D Systems' GMP products that: a) the End User will not use this GMP Product in any procedure wherein the product may be directly or indirectly administered to humans, unless the End User has obtained, or prior to their use will have obtained, an Investigational New Drug (IND) exemption from the FDA and will use the product only in accordance with the protocols of such IND and of the Institutional Review Board overseeing the proposed research, or b) the End User will use the products outside of the United States in accordance with the protocols of research approved by the Institutional Review Board or authorized ethics committee and regulatory agencies to which the End User is subject to in their territory.
R&D Systems, Inc. has the right, at its sole discretion, to modify, add or remove any terms or conditions of these End User Terms of Use without notice or liability to you. Any changes to these End User Terms of Use are effective immediately following the printing of such changes on this product insert. The most recent version of these End User Terms of Use of Product may be found at: RnDSystems.com/Legal.
You agree to review these End User Terms of Use of Product to ensure any subsequent use by you of R&D Systems' GMP Products following changes to these End User Terms of Use of Product constitutes your acceptance of all such changes.
TERMS AND CONDITIONS
The following limitation applies to R&D Systems' warranty and liability for damages: All products are warranted to meet R&D Systems' published specifications when used under normal laboratory conditions.
R&D SYSTEMS DOES NOT MAKE ANY OTHER WARRANTY OR REPRESENTATION WHATSOEVER, WHETHER EXPRESS OR IMPLIED, WITH RESPECT TO ITS PRODUCTS. IN PARTICULAR, R&D SYSTEMS DOES NOT MAKE ANY WARRANTY OF SUITABILITY, NONINFRINGEMENT, MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.
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Full details of R&D Systems' Terms and Conditions of Sale can be found online at: RnDSystems.com/Legal.
For preclinical, or clinical ex vivo use
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