GMP Human IL-21 Protein
Catalog # GMP-L21H25Features

Sterility

Designed under ISO 9001:2015 and ISO 13485:2016
Manufactured and QC tested under a GMP compliance factory
FDA DMF filed

The sterility testing was performed by membrane filtration method described in
CP<1101>, USP<71> and Eur. Ph. 2.6.1.

Mycoplasma
Negative.

Animal-Free materials

PurityBeta-lactam materials free
Batch-to-batch consistency
Stringent quality control tests>95% as determined by SDS-PAGE.

Formulation

SourceLyophilized from 0.22 μm filtered solution in PBS, pH7.4 with protectants.

GMP Human IL-21 Protein(GMP-L21H25) is expressed from human 293 cells

Contact us for customized product form or formulation.

(HEK293). It contains AA Gln 30 - Ser 162 (Accession # Q9HBE4-1).
Predicted N-terminus: Gln 30

Molecular Characterization

Shipping
This product is supplied and shipped with blue ice, please inquire the shipping
cost.

StorageUpon receipt, store it immediately at -20°C or lower for long term storage.
This protein carries no "tag".

Please avoid repeated freeze-thaw cycles.

The protein has a calculated MW of 15.5 kDa. The protein migrates as 16 kDa±3This product is stable after storage at:

kDa under reducing (R) condition (SDS-PAGE) due to glycosylation.

-20°C to -70°C for 5 years in lyophilized state;-70°C for 12 months under sterile conditions after reconstitution.

Endotoxin
Less than 10 EU/mg by the LAL method.

Host Cell Protein<0.5 ng/µg of protein tested by ELISA.

Host Cell DNA<0.02 ng/μg of protein tested by qPCR.

SDS-PAGE

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9/18/2024

GMP Human IL-21 Protein
Catalog # GMP-L21H25

GMP Human IL-21 Protein on SDS-PAGE under reducing (R) condition. Thegel was stained with Coomassie Blue. The purity of the protein is greater than95%.

Bioactivity-Bioactivity CELL BASE

GMP Human IL-21 Protein (Cat. No. GMP-L21H25) stimulates secretion ofIFN-γ by NK-92 human natural killer lymphoma cells stimulated with 10ng/mL GMP Human IL-15 Protein (Cat. No. GMP-L15H13). The specificactivity of GMP Human IL-21 Protein (Cat. No. GMP-L21H25) is >1.00×10^5 U/mg (QC tested).

Bioactivity-Stability

The Cell based assay shows that GMP Human IL-21 Protein (Cat. No. GMPL21H25) is stable at 37°C for 24 hours.

The Cell based assay shows that GMP Human IL-21 Protein (Cat. No. GMPL21H25) is stable after freezing and thawing 3 times.

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9/18/2024

GMP Human IL-21 Protein
Catalog # GMP-L21H25

The Cell based assay shows that GMP Human IL-21 Protein (Cat. No. GMPL21H25) is stable at 4°C for 6 months.

The Cell based assay shows batch-to-batch consistency between Acro's GMP
and PG IL-21.

MANUFACTURING SPECIFICATIONSACROBiosystems GMP grade products are produced under a quality management system and in compliance with relevant guidelines: Ph. Eur General Chapter
5.2.12 Raw materials of biological origin for the production of cell-based and gene therapy medicinal products; USP<92>Growth Factors and Cytokines Used in Cell
Therapy Manufacturing; USP<1043>Ancillary Materials for Cell, Gene, and Tissue-Engineered Products; ISO/TS 20399-1:2018, Biotechnology - Ancillary
Materials Present During the Production of Cellular Therapeutic Products.

ACROBiosystems Quality Management System Contents：
Designed under ISO 9001:2015 and ISO 13485:2016, Manufactured and QC tested under a GMP compliance factory.
Animal-Free materials
Materials purchased from the approved suppliers by QA
ISO 5 clean rooms and automatic filling equipment
Qualified personnel
Quality-related documents review and approve by QA
Fully batch production and control records
Equipment maintenance and calibration
Validation of analytical procedures
Stability studies conducted
Comprehensive regulatory support files
Request For Regulatory Support Files（RSF）

ACROBiosystems provide rigorous quality control tests (fully validated equipment, processes and test methods) on our GMP grade products to ensure that they meetstringent standards in terms of purity, safety, activity and inter-batch stability, and each bulk QC lot mainly contains the following specific information:
SDS-PAGE
Protein content
Endotoxin level

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9/18/2024

GMP Human IL-21 Protein
Catalog # GMP-L21H25

Residual Host Cell DNA content
Residual Host Cell Protein content
Biological activity analysis
Microbial testing
Mycoplasma testingIn vitro virus assay
Residual moisture
Batch-to-batch consistency

Background
Interleukin-21 (IL-21) is a secreted protein which belongs to the IL-15 / IL-21 family. Interleukin-21 / IL-21 belongs to a family of cytokines that bind to a composite
receptor consisting of a private receptor (IL21R) and the common cytokine receptor gamma chain (gamma(C)). Interleukin-21 / IL-21 impacts a number of cell types,
including CD8+ memory T cells, NK cells and subsets of CD4 memory T cells. The IL-21R is widely distributed on lympho-haematopoietic cells. IL-21 is apleiotropic cytokine produced by CD4+ T cells in response to antigenic stimulation. Its action generally enhances antigen-specific responses of immune cells. IL-21
promotes the anti-tumor activity of CD8+ T-cells and NK cells. IL-21 exerts its effect through binding to a specific type I cytokine receptor, IL-21R, which also
contains the γ chain (γc) found in other cytokine receptors including IL-2, IL-4, IL-7, IL-9 and IL-15. The IL-21/IL-21R interaction triggers a cascade of events
which includes activation of the tyrosine kinases JAK1 and JAK3, followed by activation of the transcription factors STAT1 and STAT3.

Clinical and Translational Updates

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9/18/2024