GMP Human SCF Protein
Catalog # GMP-SCFH25

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 SCF Protein(GMP-SCFH25) is expressed from human 293 cells(HEK293). It contains AA Glu 26 - Ala 189 (Accession # P21583-1).
Predicted N-terminus: Glu 26

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 18.5 kDa. The protein migrates as 30 kDa±3

Please avoid repeated freeze-thaw cycles.

kDa under reducing (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;Less than 10 EU/mg by the LAL method.

-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 qPCR.

SDS-PAGE

GMP Human SCF Protein on SDS-PAGE under reducing (R) condition. Thegel was stained with Coomassie Blue. The purity of the protein is greater thanwww.acrobiosystems.com

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GMP Human SCF Protein
Catalog # GMP-SCFH25

95%.

Bioactivity-Bioactivity CELL BASE

GMP Human SCF Protein (Cat. No. GMP-SCFH25) stimulates proliferation ofMo7e cell line. The specific activity of GMP Human SCF Protein is >5.00ⅹ10^5 IU/mg, which is calibrated against human SCF WHO International
Standard (NIBSC code: 91/682) (QC tested).

Bioactivity-Stability

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

The Cell based assay shows that GMP Human SCF Protein (Cat. No. GMP-SCFH25) is stable at 4°C for 180 days.

SCFH25) is stable at 37°C for 24 hours.

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GMP Human SCF Protein
Catalog # GMP-SCFH25

The Cell based assay shows that GMP Human SCF (Cat. No. GMP-SCFH25)

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

is stable after freezing and thawing 3 times.

and PG SCF.

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 SCF Protein
Catalog # GMP-SCFH25

Background
Stem Cell Factor is also known as SCF, kit-ligand, KL, steel factor, KITLG, FPH2, KL-1, Kitl, MGF, SCF, SF, or SHEP7, and is a cytokine that binds to the c-Kit
receptor (CD117). SCF can exist both as a transmembrane protein and a soluble protein. This cytokine plays an important role in hematopoiesis (formation of bloodcells), spermatogenesis, and melanogenesis. The soluble and transmembrane forms of the protein are formed by alternative splicing of the same R transcript.Solubleand transmembrane SCF is produced by fibroblasts and endothelial cells. Soluble SCF has a molecular weight of 18,5 KDa and forms a dimer. SCF plays animportant role in the hematopoiesis during embryonic development. Sites where hematopoiesis takes place, such as the fetal liver and bone marrow, all express SCF.
During development, the presence of the SCF also plays an important role in the localization of melanocytes, cells that produce melanin and control pigmentation.
SCF plays a role in the regulation of HSCs in the stem cell niche in the bone marrow. SCF may be used along with other cytokines to culture HSCs andhematopoietic progenitors. The expansion of these cells ex-vivo (outside the body) would allow advances in bone-marrow transplantation, in which HSCs aretransferred to a patient to re-establish blood formation.

Clinical and Translational Updates

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9/18/2024