GMP Human IL-1 beta Protein
Catalog # GMP-ILBH16Features

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

Formulation

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

GMP Human IL-1 beta Protein(GMP-ILBH16) is expressed from E. coli cells. It

Contact us for customized product form or formulation.

contains AA Ala 117 - Ser 269 (Accession # P01584-1).
Predicted N-terminus: Met

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".
The protein has a calculated MW of 17.5 kDa. The protein migrates as 18 kDa±3
kDa when calibrated against Star Ribbon Pre-stained Protein Marker under
reducing (R) condition (SDS-PAGE).

Please avoid repeated freeze-thaw cycles.
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.

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

www.acrobiosystems.com

9/18/2024

GMP Human IL-1 beta Protein
Catalog # GMP-ILBH16

GMP Human IL-1 beta Protein on SDS-PAGE under reducing (R) condition.
The gel was stained with Coomassie Blue. The purity of the protein is greaterthan 95% (With Star Ribbon Pre-stained Protein Marker).

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 contentBiological activity analysis
Microbial testing
Mycoplasma testingIn vitro virus assay
Residual moisture
Batch-to-batch consistencywww.acrobiosystems.com

9/18/2024

GMP Human IL-1 beta Protein
Catalog # GMP-ILBH16

Background
Interleukin-1 beta (IL-1β) is a non-secreted proinflammatory cytokine produced mainly by activated macrophages, as well as neutrophils, epithelial cells, andendothelial cells. It possesses metabolic, physiological, haematopoietic activities, and plays one of the central roles in the regulation of the immune responses. BothIL-1α and IL-1β binds to the same receptor and has similar but not identical biological properties; The mature human IL1β shares 96 % amino acid sequence identitywith rhesus and 67 % -78 % with canine, mouse and rat IL-1β.

Clinical and Translational Updates

www.acrobiosystems.com

9/18/2024