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Recombinant Human IL-10 GMP Protein, CF GMP

Catalog # 1064-GMP | R&D Systems, Inc. a Bio-Techne Brand
Animal Free
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1064-GMP-01M
1064-GMP-050

Key Product Details

  • IL-10 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-10

Source

E. coli

Accession #

Structure / Form

Noncovalently-linked homodimer

Conjugate

Unconjugated

Applications

Bioactivity

Product Specifications

Source

E. coli-derived human IL-10 protein
Ser19-Asn178, 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 visualized with Silver Staining and quantitative densitometry by Coomassie® Blue Staining. The molecular weight by mass spectrometry is 18762 Da ± 20 Da.

Endotoxin Level

<0.10 EU per 1 μg of the protein by the LAL method.

N-terminal Sequence Analysis

Met-Ser19-Pro-Gly-Gln-Gly-Thr-Gln-Ser-Glu

Predicted Molecular Mass

19 kDa

SDS-PAGE

18 kDa, reducing conditions

Activity

Measured in a cell proliferation assay using MC/9‑2 mouse mast cells. Thompson-Snipes, L. et al. (1991) J. Exp. Med. 173:507.
The ED50 for this effect is 0.0750-0.750 ng/mL.

The specific activity of recombinant human IL-10 is >2.50 x 106 units/mg, which is calibrated against the human IL-10 WHO Reference Reagent (NIBSC code: 93/722).

Host Cell Protein

< 0.500 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-10 GMP Protein, CF

GMP-grade Recombinant Human IL-10 Protein Bioactivity

GMP-grade Recombinant Human IL-10 GMP Protein (Catalog # 1064-GMP) was measured in a cell proliferation assay using MC/9-2 mouse mast cells. The ED50 for this effect is 0.0750-0.750 ng/mL. Three independent lots were tested for activity and plotted on the same graph to show lot-to-lot consistency of GMP IL-10.

GMP-grade Recombinant Human IL-10 Protein SDS-Page

2 μg/lane of GMP-grade Recombinant Human IL-10 Protein (1064-GMP) was resolved with SDS-PAGE under reducing (R) and non-reducing (NR) conditions and visualized by Coomassie® Blue staining, showing bands at 18 kDa and 16 kDa, respectively.
Purity consistency of GMP Human IL-10 Protein

Recombinant Human IL-10 GMP Protein Purity Analysis by Size Separation.

Three independent lots of Recombinant Human IL-10 GMP Protein (Catalog # 1064-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.

Formulation, Preparation and Storage

1064-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.
  • A minimum of 12 months when stored at ≤ -20 °C as supplied. Refer to lot specific COA for the Use by Date.
  • 1 month, 2 to 8 °C under sterile conditions after reconstitution.
  • 3 months, ≤ -20 °C under sterile conditions after reconstitution.

Background: IL-10

Interleukin 10, also known as cytokine synthesis inhibitory factor (CSIF), is the charter member of the IL‑10 family of alpha‑helical cytokines that also includes IL‑19, IL‑20, IL‑22, IL‑24, and IL‑26/AK155 (1, 2). IL‑10 is secreted by many activated hematopoietic cell types as well as hepatic stellate cells, keratinocytes, and placental cytotrophoblasts (2 ‑ 5). Mature human IL‑10 shares 72% ‑ 86% amino acid sequence identity with bovine, canine, equine, feline, mouse, ovine, porcine, and rat IL‑10. Whereas human IL‑10 is active on mouse cells, mouse IL‑10 does not act on human cells (6, 7). IL‑10 is a 178 amino acid molecule that contains two intrachain disulfide bridges and is expressed as a 36 kDa noncovalently associated homodimer (6, 8, 9). The IL‑10 dimer binds to two IL‑10 R alpha/IL‑10 R1 chains, resulting in recruitment of two IL‑10 R beta/IL‑10 R2 chains and activation of a signaling cascade involving JAK1, TYK2, and STAT3 (10). IL‑10 R beta does not bind IL‑10 by itself but is required for signal transduction (1). IL‑10 R beta also associates with IL‑20 R alpha, IL‑22 R alpha, or IL‑28 R alpha to form the receptor complexes for IL‑22, IL‑26, IL‑28, and IL‑29 (11 ‑ 13). IL‑10 is a critical molecule in the control of viral infections and allergic and autoimmune inflammation (14 ‑ 16). It promotes phagocytic uptake and Th2 responses but suppresses antigen presentation and Th1 proinflammatory responses (2).

References

  1. Pestka, S. et al. (2004) Annu. Rev. Immunol. 22:929.
  2. Sabat, R. et al. (2010) Cytokine Growth Factor Rev. 21:331.
  3. Mathurin, P. et al. (2002) Am. J. Physiol. Gastrointest. Liver Physiol. 282:G981.
  4. Grewe, M. et al. (1995) J. Invest. Dermatol. 104:3.
  5. Szony, B.J. et al. (1999) Mol. Hum. Reprod. 5:1059.
  6. Vieira, P. et al. (1991) Proc. Natl. Acad. Sci. 88:1172.
  7. Hsu, D.-H. et al. (1990) Science 250:830.
  8. Windsor, W.T. et al. (1993) Biochemistry 32:8807.
  9. Syto, R. et al. (1998) Biochemistry 37:16943.
  10. Kotenko, S.V. et al. (1997) EMBO J. 16:5894.
  11. Kotenko, S.V. et al. (2000) J. Biol. Chem. 276:2725.
  12. Hor, S. et al. (2004) J. Biol. Chem. 279:33343.
  13. Sheppard, P. et al. (2003) Nat. Immunol. 4:63.
  14. Fitzgerald, D.C. et al. (2007) Nat. Immunol. 8:1372.
  15. Wu, K. et al. (2007) Cell. Mol. Immunol. 4:269.
  16. Blackburn, S.D. and E.J. Wherry (2007)Trends Microbiol. 15:143.

Long Name

Interleukin 10

Alternate Names

CSIF, GVHDS, IL10, IL10A, TGIF

Entrez Gene IDs

3586 (Human); 16153 (Mouse); 25325 (Rat); 397106 (Porcine); 403628 (Canine); 102133450 (Cynomolgus Monkey); 493683 (Feline); 100715618 (Guinea Pig); 2949786 (Viral)

Gene Symbol

IL10

UniProt

Additional IL-10 Products

Product Documents for Recombinant Human IL-10 GMP Protein, CF

Certificate of Analysis

To download a Certificate of Analysis, please enter a lot number in the search box below.

Note: Certificate of Analysis not available for kit components.

Manufacturing Specifications

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:

  • 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.

Purification

  • 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.

Please read our complete Animal-Free Statement.

Product Specific Notices for Recombinant Human IL-10 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.

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.

For preclinical, or clinical ex vivo use

Reconstitution Calculator

The reconstitution calculator allows you to quickly calculate the volume of a reagent to reconstitute your vial. Simply enter the mass of reagent and the target concentration and the calculator will determine the rest.

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