Recombinant Human IL-21 GMP Protein, CF

Recombinant Human IL-21 GMP Protein, CF Summary

• 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

Product Specifications

Product Datasheets

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 ( gamma _c) as a receptor subunit. gamma _c 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 gamma _c 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).

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:

• Designed, manufactured and tested under an ISO 9001:2015 and ISO 13485:2016 certified quality system
• Documented and controlled manufacturing process
• Control of documentation and process changes by QA
• Personnel training programs
• Raw material inspection and vendor qualification/monitoring program
• Validated equipment, processes and test methods
• Equipment calibration and maintenance schedules using a Regulatory Asset Manager
• Facility/Utilities maintenance, contamination controls, safety and pest control programs
• Material review process for variances
• Robust product stability program following relevant ICH guidelines
  
  

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 application. Each product is provided with a lot-specific Certificate of Analysis that contains the product's specifications and test results. Quality control testing may include, but is not limited to:

• N-terminal amino acid analysis
• SDS-PAGE purity analysis
• Molecular weight analysis via mass spectrometry
• Endotoxin assessment per USP <85> and Ph. Eur. 2.6.14 guidelines
• Bioassay analysis
• Microbial testing per USP <71> and Ph. Eur. 2.6.1 guidelines
• Host cell protein assessment
• Host cell DNA assessment
• Mycoplasma assessment
  
  

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 and St. Paul, 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.
  
  

Purification

• Protein purification columns are animal-free.
• Bulk proteins are filtered using animal-free filters.
• Purified proteins are stored in animal-free containers.

Please read our complete Animal-Free Statement

Product Specific Notices

Full terms and conditions of sale can be found online in the Protein Sciences Segment T&Cs at: Terms & Conditions.

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