Recombinant Human IL-7 GMP Protein, CF
New! Bypass reconstitution steps by using a liquid formulation of GMP-grade Recombinant Human IL-7. Find out more here.
Recombinant Human IL-7 GMP Protein, CF Summary
- IL-7 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-7
Product Specifications
Asp26-His177, with an N-terminal Met
Produced using non-animal reagents in an animal-free laboratory.
Manufactured and tested under cGMP guidelines.
Analysis
Product Datasheets
BT-007-GMP/LQ (liquid)
BT-007-GMP
Formulation | Lyophilized from a 0.2 μm filtered solution in PBS with Trehalose. |
Reconstitution | Reconstitute at 100-500 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.
|
BT-007-GMP/LQ
Formulation | Supplied as a 0.2 μm filtered solution in PBS. |
Shipping | The product is shipped with dry ice or equivalent. Upon receipt, store it immediately at the temperature recommended below. |
Stability & Storage: | Use a manual defrost freezer and avoid repeated freeze-thaw cycles.
|
Scientific Data
GMP-grade Recombinant Human IL-7 (Catalog # BT-007-GMP) stimulates proliferation of PHA-activated human peripheral blood lymphocytes. The ED50 for this effect is 0.100-0.500 ng/mL. Three independent lots were tested for activity and plotted on the same graph to show lot-to-lot consistency of GMP IL-7.
2 μg/lane of GMP-grade Recombinant Human IL-7 Protein (Catalog # BT-007-GMP) was resolved with SDS-PAGE under reducing (R) and non-reducing (NR) conditions and visualized by Coomassie® Blue staining, showing a single band at 17 kDa.
Analysis of GMP-grade Recombinant Human IL-7 (Catalog # BT-007-GMP), showing a major peak at 17501 Da.
Four samples of GMP-grade human IL-7 (Catalog number BT-007-GMP, green circles) were interpolated with the human IL-7 Quantikine High Sensitivity ELISA Kit (HS750) standard curve (black circles) using 4PL logistic regression analysis. The IL-7 Quantikine High Sensitivity ELISA Kit has an assay range of 0.156-10 pg/mL for cell culture supernates and 0.25-16 pg/mL for serum, EDTA plasma and citrate plasma.
Thirteen samples of GMP-grade human IL-7 (Catalog number BT-007-GMP, green circles) were interpolated with the Simple Plex Human IL-7 cartridge (SPCKB-PS-000506) standard curve (black circles) using 4PL logistic regression analysis. The Simple Plex IL-7 cartridge has an assay range of 0.57-2,170 pg/mL.
Three independent lots of Recombinant Human IL-7 GMP Protein (Catalog # BT-007-GMP) were analyzed by Maurice CE-SDS PLUS (IS is an Internal Standard). A gel-like representation of the purity analysis data (inset) can be obtained from the Lane View feature in Compass software for iCE. Profiles from the three runs were superimposed, showing excellent manufacturing consistency.
Three independent lots of Recombinant Human IL-7 GMP Protein (Catalog # BT-007-GMP) were analyzed by Maurice icIEF using native fluorescence detection (Mkr 5.85 and 9.99 are pI Markers). Profiles from the three runs were superimposed, showing excellent manufacturing consistency.
Reconstitution Calculator
Background: IL-7
IL-7 (interleukin-7) is a 25 kDa cytokine of the hemopoietin family that plays important roles in lymphocyte differentiation, proliferation, and survival (1-4). Human IL‑7 cDNA encodes 177 amino acids (aa) that include a 25 aa signal peptide (3). Human IL-7 shares approximately 60-63% aa sequence identity with mouse, rat, canine and feline IL-7, and 72-76% with equine, bovine, ovine, and porcine IL-7. Human and mouse IL-7 exhibit cross-species activity (2, 3).
- Sasson, S.C. et al. (2006) Curr. Drug Targets 7:1571.
- Barata, J.T. et al. (2006) Exp. Hematol. 34:1133.
- Goodwin, R.G. et al. (1990) Proc. Natl. Acad. Sci. USA 86:302.
- Namen, A.E. et al. (1988) Nature 333:571.
- Shalapour, S. et al. (2012) PLoS ONE 7: e31939.
- Saini, M. et al. (2009) Blood 113:5793.
- Park, J.H. et al. (2004) Immunity 21:289.
- Vranjkovic, A. et al. (2007) Int. Immunol. 19:1329.
- Sudo, T. et al. (1993) Proc. Natl. Acad. Sci. 90:9125.
- Seddon, B. et al. (2003) Nat. Immunol. 4:680.
- Schluns, K.S. et al. (2000) Nat. Immunol. 5:426.
- Peschon, J.J. et al. (1994) J. Exp. Med. 180:1955.
- Pribyl, J.A. and T.W. LeBien (1996) Proc. Natl. Acad. Sci. 93:10348.
- Johnson, K. et al. (2012) J. Immunol. 188:6084.
- Nodland, S.E. et al. (2011) Blood 118:2116.
- Wang, C. et al. (2022) Int. J. Mol. Sci. 23:10370.
- Pang, N. et al. (2021) J Hematol Oncol. 14:118.
- Li, L. et al. (2022) Sci Rep. 12:12506.
- Xu, Y. et al. (2014) Blood. 123:3750.
- Marton,C. et al. (2022) Cancer Gene Ther. 29:961.
- Winer, H. et al. (2022) Cytokine. 160:156049.
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.
R&D Systems sells GMP grade products for preclinical or clinical ex vivo cell therapy applications. 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
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.
NOTWITHSTANDING ANY OTHER PROVISIONS OF THESE TERMS AND/OR ANY OTHER AGREEMENT BETWEEN R&D SYSTEMS AND PURCHASER FOR THE PURCHASE OF THE PRODUCTS, R&D SYSTEMS' TOTAL LIABILITY TO PURCHASER ARISING FROM OR IN RELATION TO THESE TERMS, AN AGREEMENT BETWEEN THE PARTIES OR THE PRODUCTS, WHETHER ARISING IN CONTRACT, TORT OR OTHERWISE SHALL BE LIMITED TO THE TOTAL AMOUNT PAID BY PURCHASER TO R&D SYSTEMS FOR THE APPLICABLE PRODUCTS. IN NO EVENT WILL R&D SYSTEMS BE LIABLE FOR THE COST OF PROCUREMENT OF SUBSTITUTE GOODS.
Full details of R&D Systems' Terms and Conditions of Sale can be found online at: RnDSystems.com/Legal.
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