GMP Human DLL4 Protein, Fc Tag
Catalog # GMP-DL4H28Features

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 DLL4 Protein, Fc Tag(GMP-DL4H28) is expressed from humanContact us for customized product form or formulation.

293 cells (HEK293). It contains AA Ser 27 - Pro 524 (Accession #NP_061947.1).

Shipping

Predicted N-terminus: Ser 27

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

Molecular Characterization

cost.

StorageUpon receipt, store it immediately at -20°C or lower for long term storage.
This protein carries a human IgG1 Fc tag at the C-terminus.
The protein has a calculated MW of 80.7 kDa. The protein migrates as 90 kDa±3kDa under reducing (R) condition (SDS-PAGE) due to glycosylation.

Endotoxin

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.

Less than 10 EU/mg by the LAL method.

Protein A<5 ppm of protein tested by ELISA.

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 DLL4 Protein, Fc Tag
Catalog # GMP-DL4H28

GMP Human DLL4 Protein, Fc Tag on SDS-PAGE under reducing (R)condition. The gel was stained with Coomassie Blue. The purity of the protein
is greater than 95%.

Bioactivity-SPR

GMP Human DLL4 Protein, Fc Tag (Cat. No. GMP-DL4H28) captured onProtein A Chip can bind Human NOTCH1 Protein, His Tag, premium grade(Cat. No. NO1-H52H3) with an affinity constant between 1.00 nM - 150 nM asdetermined in a SPR assay (Biacore 8K) (QC tested).

Application Data

CD34+ CD45+ hematopoietic cells were seeded on GMP Human DLL4 Protein, Fc Tag (Cat. No. GMP-DL4H28) - coated plates and differentiated for 26 days, thenflow cytometry was used to detect the expression of T-cell progenitor markers, CD7 and CD5. GMP Human DLL4 Protein, Fc Tag (Cat. No. GMP-DL4H28)
together with other growth factors could induce the formation of CD7+ and CD7+ CD5+ T-cell progenitors. However, the cells cultured without GMP Human DLL4Protein, Fc Tag (Cat. No. GMP-DL4H28) - coated plates expressed neither CD5 nor CD7 (Routinely tested).

www.acrobiosystems.com

9/18/2024

GMP Human DLL4 Protein, Fc Tag
Catalog # GMP-DL4H28

Bioactivity-Stability

The SPR based assay shows that GMP Human DLL4 Protein, Fc Tag (Cat. No.
GMP-DL4H28) is stable at 37℃ for 24 hours.

The SPR based assay shows that GMP Human DLL4 Protein, Fc Tag (Cat. No.
GMP-DL4H28) is stable after freezing and thawing 3 times.

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 materialsMaterials 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

www.acrobiosystems.com

9/18/2024

GMP Human DLL4 Protein, Fc Tag
Catalog # GMP-DL4H28

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
Delta-like protein 4 (DLL4) is also known as Drosophila Delta homolog 4 (Delta4), which contains one DSL domain and eight EGF-like domains. DLL4 isexpressed in vascular endothelium. DLL4 is involved in the Notch signaling pathway as Notch ligand, which can activates NOTCH1 and NOTCH4. DLL4 isinvolved in angiogenesis and negatively regulates endothelial cell proliferation and migration and angiogenic sprouting. DLL4 can bind to Notch-1 and Notch-4.

Clinical and Translational Updates

www.acrobiosystems.com

9/18/2024