GMP Human IL-15 Protein
Catalog # GMP-L15H13Features

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
Beta-lactam materials free
Batch-to-batch consistency

In vitro virus assay
Negative.

PurityStringent quality control tests
No animal derived peptone and lactose used in production process>95% as determined by SDS-PAGE.

Formulation

SourceGMP Human IL-15 Protein(GMP-L15H13) is expressed from E. coli cells. It

Lyophilized from 0.22 μm filtered solution in 25 mM His, pH6.2 withcontains AA Asn 49 - Ser 162 (Accession # P40933-1).

protectants.

Predicted N-terminus: Met

Molecular Characterization

Contact us for customized product form or formulation.

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

Storage
This protein carries no "tag".
The protein has a calculated MW of 12.8 kDa. The protein migrates as 13 kDa±3

Upon receipt, store it immediately at -20°C or lower for long term storage.

kDa under reducing (R) condition (SDS-PAGE).

Please avoid repeated freeze-thaw cycles.

Endotoxin

This product is stable after storage at:

Less than 10 EU/mg by the LAL method.

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

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

Host Cell DNA<0.02 ng/μg of protein tested by DNA Fluorescent Staining method.

SDS-PAGE

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9/30/2024GMP Human IL-15 Protein
Catalog # GMP-L15H13

GMP Human IL-15 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-15 Protein (Cat. No. GMP-L15H13) stimulates proliferationof CTLL-2 cells. The specific activity of GMP Human IL-15 is > 8.00ⅹ10^6IU/mg, which is calibrated against human IL-15 WHO International Standard(NIBSC code: 95/554) (QC tested).

Application Data

Human PBMCs were cultured in CelThera™ GMP T Cell Expansion Medium (ACROBiosystems, Cat. No. GMP-CM3101) with 50 IU/mL GMP Human IL-2
Protein (ACROBiosystems, Cat. No. GMP-L02H14), 5 ng/mL GMP Human IL-7 Protein (ACROBiosystems, Cat. No. GMP-L07H24) and 1, 10 or 100 ng/mL GMP
Human IL-15 Protein (ACROBiosystems, Cat. No. GMP-L15H13) for 13 days. The result shows that Acro's GMP Human IL-15 Protein activity is consistent acrossbatches.

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9/30/2024

GMP Human IL-15 Protein
Catalog # GMP-L15H13

Human PBMCs were cultured in X-VIVO-15 with 50 IU/mL GMP Human IL-2 Protein (ACROBiosystems, Cat. No. GMP-L02H14), 5 ng/mL GMP Human IL-7Protein (ACROBiosystems, Cat. No. GMP-L07H24) and 1, 10 or 100 ng/mL GMP Human IL-15 Protein (ACROBiosystems, Cat. No. GMP-L15H13) for 14 days.
The result shows that Acro's GMP Human IL-15 Protein activity is consistent across batches.

Bioactivity-Stability

The Cell based assay shows that GMP Human IL-15 Protein (Cat. No. GMP-

The Cell based assay shows that GMP Human IL-15 Protein (Cat. No. GMP-L15H13) is stable at 37°C for 48 hours.

L15H13) is stable at 4℃ for 3 months in 4℃ real time stability experiment.

The Cell based assay shows batch-to-batch consistency between Acro's GMP
The Cell based assay shows that GMP Human IL-15 Protein (Cat. No. GMP-and PG IL-15.

L15H13) is stable after freezing and thawing 3 times.

MANUFACTURING SPECIFICATIONS

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9/30/2024

GMP Human IL-15 Protein
Catalog # GMP-L15H13

ACROBiosystems 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 QAISO 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
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 15 is also known as IL15, IL-15, and is a cytokine with structural similarity to IL-2. Like IL-2, IL-15 binds to and signals through the IL-2/IL-15 beta
chain (CD122) and the common gamma chain (gamma-C, CD132). IL-15 is secreted by mononuclear phagocytes (and some other cells) following infection byvirus(es). This cytokine induces cell proliferation of natural killer cells; cells of the innate immune system whose principal role is to kill virally infected cells.
Interleukin 15 (IL-15) regulates T and natural killer (NK) cell activation and proliferation. Survival signals that maintain memory T cells in the absence of antigen arewww.acrobiosystems.com

9/30/2024

GMP Human IL-15 Protein
Catalog # GMP-L15H13

provided by IL-15. This cytokine is also implicated in NK cell development. In rodent lymphocytes, IL-15 prevents apoptosis by inducing an apoptosis inhibitor,
BCL2L1/BCL-x(L). IL-15 has been shown to enhance the anti-tumor immunity of CD8+ T cells in pre-clinical models. A phase I clinical trial to evaluate the safety,
dosing, and anti-tumor efficacy of IL-15 in patients with metastatic melanoma and renal cell carcinoma (kidney cancer) has begun to enroll patients at the National
Institutes of Health.

Clinical and Translational Updates

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9/30/2024