GMP Human IFN-gamma Protein
Catalog # GMP-IFGH24

Features

Sterility

Designed under ISO 9001:2015 and ISO 13485:2016
Manufactured and QC tested under a GMP compliance factory
Animal-Free materials
Beta-lactam materials free

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

Mycoplasma
Negative.

PurityBatch-to-batch consistency
Stringent quality control tests>95% as determined by SDS-PAGE.

Formulation

SourceGMP Human IFN-gamma Protein(GMP-IFGH24) is expressed from human 293
cells (HEK293). It contains AA Gln 24 - Gln 166 (Accession # P01579).
Predicted N-terminus: Gln 24

Molecular Characterization

Lyophilized from 0.22 μm filtered solution in PBS, pH7.4 with protectants.
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 16.8 kDa. The protein migrates as 15 kDa,
19 kDa and 24 kDa±3 kDa under reducing (R) condition (SDS-PAGE) due toglycosylation.

Upon receipt, store it immediately at -20°C or lower for long term storage.
Please avoid repeated freeze-thaw cycles.
This product is stable after storage at:-20°C to -70°C for 5 years in lyophilized state;

Endotoxin-70°C for 12 months under sterile conditions after reconstitution.

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

GMP Human IFN-gamma Protein on SDS-PAGE under reducing (R)condition. The gel was stained with Coomassie Blue. The purity of the proteinwww.acrobiosystems.com

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GMP Human IFN-gamma Protein
Catalog # GMP-IFGH24

is greater than 95%.

Bioactivity-Bioactivity CELL BASE

GMP Human IFN-gamma Protein (Cat. No. GMP-IFGH24) inhibits theThe activity of GMP Human IFN-gamma Protein (Cat. No. GMP-IFGH24)

proliferation of HT-29 cells. The specific activity of GMP Human IFN-gamma

was higher than other competing products.

Protein is > 2.00×10^7 IU/mg, which is calibrated against human interferon
gamma Standard (NIBSC code: 87/586) (QC tested).

Bioactivity-Stability

The Cell based assay shows that GMP Human IFN-gamma Protein (Cat. No.
GMP-IFGH24) is stable at 37°C for 24 hours.

www.acrobiosystems.com

The Cell based assay shows that GMP Human IFN-gamma Protein (Cat. No.
GMP-IFGH24) is stable after freezing and thawing 3 times.

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GMP Human IFN-gamma Protein
Catalog # GMP-IFGH24

The Cell based assay shows that GMP Human IFN-gamma Protein (Cat. No.

The Cell based assay shows batch-to-batch consistency between Acro's GMP

GMP-IFGH24) is stable at 4°C for 6 months.

and PG IFN-gamma.

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
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 consistencywww.acrobiosystems.com

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GMP Human IFN-gamma Protein
Catalog # GMP-IFGH24Background
Interferon-gamma (IFN-γ/IFNG) is a dimerized soluble cytokine that is the only member of the type II class of interferon. This interferon was originally called
macrophage-activating factor, a term now used to describe a larger family of proteins to which IFN-γ belongs. IFN-gamma has been used in a wide variety of clinicalindications. Interferon-gamma (IFNgamma) is a central regulator of the immune response and signals via the Janus Activated Kinase (JAK)-Signal Transducer andActivator of Transcription (STAT) pathway. Interferon gamma has broader roles in activation of innate and adaptive immune responses to viruses and tumors, in partthrough upregulating transcription of genes involved in cell cycle regulation, apoptosis, and antigen processing/presentation. Despite this, rodent and humantrophoblast cells show dampened responses to IFNG that reflect the resistance of these cells to IFNG-mediated activation of major histocompatibility complex(MHC) class II transplantation antigen expression.

Clinical and Translational Updates

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