Recombinant Human IL-21 GMP Protein, CF GMP Best Seller

R&D Systems, part of Bio-Techne | Catalog # BT-021-GMP

R&D Systems, part of Bio-Techne
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Lyophilized
BT-021-GMP-01M
BT-021-GMP-025
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Liquid
BT-021-GMP-01M/LQ
BT-021-GMP-025/LQ
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Key Product Details

  • IL-21 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-21

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 using non-animal reagents in an animal-free laboratory.Manufactured and tested under cGMP guidelines.

Purity

>95%, by SDS-PAGE with quantitative densitometry by Coomassie® Blue Staining. The molecular weight by mass spectrometry is 15396 Da ± 50 Da.

Endotoxin Level

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

N-terminal Sequence Analysis

Met-Gln32-Asp-Arg-His-Met-Ile-Arg-Met-Arg

Predicted Molecular Mass

15 kDa

SDS-PAGE

15-17 kDa, under 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.

Host Cell Protein

<0.100 ng per μg of protein when tested by ELISA.

Mycoplasma

Negative for Mycoplasma.

Host Cell DNA

<0.00150 ng per µg of protein when tested by PCR.

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

Recombinant Human IL-21 GMP Protein Bioactivity.

GMP-grade Recombinant Human IL-21 Protein (Catalog # BT-021-GMP) as measured in a cell proliferation assay using B9 mouse hybridoma cells. The ED50 for this effect is 5.00-50.0 ng/mL. Three independent lots were tested foractivity and plotted on the same graph to show lot-to-lot consistency of GMP IL-21.

Equivalent Bioactivity of GMP and Animal-Free grades of Recombinant Human IL-21.

Equivalent bioactivity of GMP (Catalog # BT-021-GMP) and Animal-Free (BT-021-AFL) grades of Recombinant Human IL-21 as measured in a cell proliferation assay using B9 mouse hybridoma cells (orange and green, respectively).

Recombinant Human IL-21 GMP Protein SDS-PAGE.

2 μg/lane of Recombinant Human IL-21 GMP Protein (Catalog # BT-021-GMP) was resolved with SDS-PAGE under reducing (R) and non-reducing (NR) conditions and visualized by Coomassie® Blue staining, showing bands at 15-17 kDa, under reducing conditions.
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Formulation, Preparation and Storage

Lyophilized: BT-021-GMP
Formulation Lyophilized from a 0.2 μm filtered solution in PBS with Trehalose.
Reconstitution Reconstitute the 25 μg size at 250 μg/mL in PBS. Reconstitute all other sizes 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.
  • 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.
Liquid: BT-021-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.
  • A minimum of 12 months when stored at ≤ -65 °C as supplied. Refer to lot specific COA for the Use by Date.
  • 1 month, 2 to 8 °C under sterile conditions after opening.
  • 3 months, -20 °C under sterile conditions after opening.

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.

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 <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 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

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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