Recombinant Human IL-21 GMP Protein, CF GMP

R&D Systems, part of Bio-Techne | Catalog # 8879-GMP

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R&D Systems, part of Bio-Techne
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Key Product Details

Source

E. coli

Accession #

Q9HBE4.3

Conjugate

Unconjugated

Applications

Bioactivity

View all IL-21 Proteins and Enzymes »

Product Specifications

Source

E. coli-derived human IL-21 protein
Gln32-Ser162, with a N-terminal Met
Produced in an animal-free laboratory. Manufactured and tested under cGMP guidelines

Purity

>95%, by SDS-PAGE visualized with Silver Staining and 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-Gln-Asp-Arg-His-Met-Ile-Arg-Met-Arg

Predicted Molecular Mass

15 kDa

SDS-PAGE

16 kDa, reducing conditions

Activity

Measured in a cell proliferation assay using B9 mouse hybridoma cells.

The ED50 for this effect is 5.00-50.0 ng/mL.

The specific activity of recombinant human IL-21 is >1.00 x 106 units/mg, which is calibrated against an internal reference standard for human IL-21.



Measured by its ability to enhance IFN-gamma secretion in NK-92 human natural killer lymphoma cells.
The ED50 for this effect is ≤8 ng/mL.

Host Cell Protein

< 0.1 ng per μg of protein when tested by ELISA.

Mycoplasma

Negative for Mycoplasma.

Scientific Data Images for Recombinant Human IL-21 GMP Protein, CF

Recombinant Human IL‑21 GMP Protein Bioactivity.

Recombinant Human IL‑21 GMP (Catalog # 8879-GMP) induces B9 mouse hybridoma cell proliferation. The ED50 for this effect is 5.00-50.0 ng/mL
Recombinant Human IL-21 GMP Protein Bioactivity

Recombinant Human IL-21 GMP Protein Bioactivity

GMP-grade Recombinant Human IL-21 (Catalog # 8879‑GMP) enhances IFN-gamma secretion in NK-92 human natural killer lymphoma cells. The ED50 for this effect is ≤8 ng/mL. Three independent lots were tested for activity and plotted on the same graph to show lot-to-lot consistency of GMP IL-21.
Recombinant Human IL-21 GMP Protein SDS-PAGE

Recombinant Human IL-21 GMP Protein SDS-PAGE

2 μg/lane of GMP-grade Recombinant Human IL-21 (Catalog # 8879-GMP) was resolved with SDS-PAGE under reducing (R) and non-reducing (NR) conditions and visualized by Coomassie® Blue staining, showing R band at 16.4 kDa and NR band at 14.8 kDa, respectively.

Formulation, Preparation and Storage

8879-GMP
Formulation Lyophilized from a 0.2 μm filtered solution in PBS.
Reconstitution Reconstitute at 100-200 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-21

Interleukin-21 (IL-21) is an approximately 14 kDa four-helix-bundle member of the family of cytokines that utilize the common gamma chain ( gammac) as a receptor subunit. gammac is also a subunit of the receptors for IL-2, IL-4, IL-7, IL-9, and IL-15 (1). IL-21 is produced by activated T follicular helper cells (Tfh), Th17 cells, and NKT cells (2-6). It exerts its biological effects through a heterodimeric receptor complex of gammac and the IL-21-specific IL-21 R (2, 7). Tfh-derived IL-21 plays an important role in the development of humoral immunity through its autocrine effects on the Tfh cell and paracrine effects on immunoglobulin affinity maturation, plasma cell differentiation, and B cell memory responses (4, 8, 9). It is also required for the migration of dendritic cells to draining lymph nodes (10). IL-21 regulates several aspects of T cell function. It co-stimulates the activation, proliferation, and survival of CD8+ T cells and NKT cells and promotes Th17 cell polarization (3, 5, 6, 11, 12). It blocks the generation of regulatory T cells and their suppressive effects on CD4+ T cells (13, 14). IL-21 R engagement enhances the cytolytic activity and IFN-gamma production of activated NK cells but limits the expansion of resting NK cells (15). In addition, IL-21 suppresses cutaneous hypersensitivity reactions by limiting allergen-specific IgE production and mast cell degranulation (16). Dysregulation of the IL-21/IL-21 R system contributes to the development of multiple immunological disorders (1, 17). The 133 amino acid (aa) mature human IL-21 shares 63% and 61% aa sequence identity with mouse and rat IL-21, respectively. Alternative splicing generates an additional isoform with a substitution of the C-terminal 16 amino acids (18).

References

  1. Tangye, S.G. (2015) Curr. Opin. Immunol. 34:107.
  2. Parrish-Novak, et al. (2000) Nature 408:57.
  3. Coquet, J.M. et al. (2007) J. Immunol. 178:2827.
  4. Vogelzang, A. et al. (2008) Immunity 29:127.
  5. Korn, T. et al. (2007) Nature 448:484.
  6. Nurieva, R. et al. (2007) Nature 448:480.
  7. Asao, H. et al. (2001) J. Immunol. 167:1.
  8. Zotos, D. et al. (2010) J. Exp. Med. 207:365.
  9. Rankin, A.L. et al. (2011) J. Immunol. 186:667.
  10. Jin, H. et al. (2009) J. Clin. Invest. 119:47.
  11. Frohlich, A. et al. (2009) Science 324:1576.
  12. Yi, J.S., et al. (2009) Science 324:1572.
  13. Peluso, I. et al. (2007) J. Immunol. 178:732.
  14. Bucher, C. et al. (2009) Blood 114:5375.
  15. Kasaian, M.T. et al. (2002) Immunity 16:559.
  16. Tamagawa-Mineoka, R. et al. (2011) J. Invest. Dermatol. 131:1513.
  17. Ma, J. et al. (2011) Cytokine 56:133.
  18. Rahman, M. et al. (2007) FEBS Lett. 581:4001.

Long Name

Interleukin 21

Alternate Names

CVID11, IL21, Za11

Entrez Gene IDs

59067 (Human); 60505 (Mouse); 365769 (Rat); 442935 (Canine); 100344172 (Rabbit)

Gene Symbol

IL21

UniProt

Q9HBE4.3

Additional IL-21 Products

Product Documents for Recombinant Human IL-21 GMP Protein, CF

Product Datasheets

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.

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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:

  • 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
  • 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 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-21 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

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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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