GMP Human IL-6 Protein
Catalog # GMP-L06H27

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 IL-6 Protein(GMP-L06H27) is expressed from human 293 cells(HEK293). It contains AA Val 30 - Met 212 (Accession # P05231).
Predicted N-terminus: Val 30

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".

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

The protein has a calculated MW of 20.8 kDa. The protein migrates as 23-29

Please avoid repeated freeze-thaw cycles.

kDa when calibrated against Star Ribbon Pre-stained Protein Marker underreducing (R) condition (SDS-PAGE) due to glycosylation.

Endotoxin

This product is stable after storage at:-20°C to -70°C for 5 years in lyophilized state;-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

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10/12/2024

GMP Human IL-6 Protein
Catalog # GMP-L06H27

GMP Human IL-6 Protein on SDS-PAGE under reducing (R) condition. Thegel was stained with Coomassie Blue. The purity of the protein is greater than
95% (With Star Ribbon Pre-stained Protein Marker).

Bioactivity-Bioactivity CELL BASE

GMP Human IL-6 Protein (Cat. No. GMP-L06H27) stimulates proliferation ofTF-1 human erythroleukemic cell line. The specific activity of GMP HumanIL-6 Protein is > 1.00×10^8 IU/mg, which is calibrated against human IL-6
WHO International Standard (NIBSC code: 21/308) (QC tested).

Application Data

GMP Human SCF Protein (Cat. No. GMP-SCFH25), Human Flt-3 Ligand Protein (Cat. No. GMP-FLLH28), GMP Human IL-3 Protein (Cat. No. GMP-L03H18)
and GMP Human IL-6 Protein (Cat. No. GMP-L06H27) could support the rapid cell expansion and good cell viability of CD34+ hematopoietic stem cells.

Bioactivity-Stability

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10/12/2024

GMP Human IL-6 Protein
Catalog # GMP-L06H27

The Cell based assay shows that GMP Human IL-6 Protein (Cat. No. GMPL06H27) is stable at 37 ℃ for 24 hours.
The Cell based assay shows that GMP Human IL-6 Protein (Cat. No. GMPL06H27) is stable after freezing and thawing 3 times.

The Cell based assay shows that GMP Human IL-6 Protein (Cat. No. GMP-

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

L06H27) is stable at 4℃ for 6 months.

and PG IL-6.

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

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10/12/2024

GMP Human IL-6 Protein
Catalog # GMP-L06H27

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 6 (IL-6) is also known as HGF, BSF2,HSF, IFNB2 and IL-6, originally identified as a B cell differentiation factor, is a multifunctional cytokine that
regulates immune responses, hematopoiesis, acute phase responses, and inflammatory reactions.It is secreted by T cells, macrophages , monocytes,fibroblasts,endothelial cells,et.al. to stimulate immune response to trauma, especially burns or other tissue damage leading to inflammation. Interleukin 6 has beenshown to interact with interleukin-6 receptor and glycoprotein. IL-6 is relevant to many disease processes such as diabetes,atherosclerosis, depression,Alzheimer'sDisease,systemic,lupus erythematosus,prostate cancer and rheumatoid arthritis. Advanced/metastatic cancer patients have higher levels of IL-6 in their blood.Hence
there is an interest in developing anti-IL-6 agents as therapy against many of these diseases.

Clinical and Translational Updates

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10/12/2024