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CTGrade GMP rh M-CSF is a recombinant human protein that is produced from E. coli and is designed to support preclinical and clinical research, as well as commercial applications, and offers:
High biological activity verified by a relevant bioactivity assay
Low endotoxin levels
≥ 97% purity
High lot-to-lot consistency
Size: 50 µg, 100 µg, and 1 mg. Custom sizes and packaging available on request.
M-CSF (macrophage colony-stimulating factor) is a hematopoietic growth factor with broad production across different cell types.
Regulates monocyte and macrophage development to maintain homeostasis
Influences various processes related to immunology, bone health, fertility, and pregnancy regulation
Exists primarily in the bloodstream and tissues since it is generated by stromal cells
For the development of advanced cell therapies, FUJIFILM Irvine Scientific is your one-stop-shop for the high-performing recombinant proteins required for expansion, proliferation, differentiation, and activation of immune and stem cells. Our CTGrade GMP recombinant proteins can be purchased separately or as a bundle with one of our high-performing PRIME-XV or classical media for a cost-effective solution.
The biological activity of CTGrade GMP interleukins and growth factors is standardized, where applicable, to WHO International standards, providing cell and gene therapy developers consistent, lot-to-lot biological activity and performance.
The CTGrade GMP products are manufactured in a facility that does not use or process beta-lactam containing materials. No animal- or human-derived materials were used during manufacturing or as ingredients. These products are manufactured, tested, and released in an ISO 9001:2015 certified facility following cGMP practices. USP chapter <1043> for ancillary materials has been considered in the manufacture of these products.
SDS-PAGE Showing a Single Prominent Band at 34 kDa
Figure 1. CTGrade GMP rh M-CSF (1μg) was resolved with SDS-PAGE under non-reducing (NR) conditions and visualized by InstantBlue staining showing a prominent band at 34 kDa. Predicted Molecular weight is 37.1 kDa but runs on SDS-PAGE at ~34 kDa.
Cell-Based Proliferation Assay
Figure 2. The biological activity of CTGrade GMP rh M-CSF was determined in a MNFS-60 cell-based proliferation assay.
CTGrade GMP rh M-CSF is lyophilized from a 0.2 μm filtered solution containing 10 mM sodium phosphate and 50 mM sodium chloride, pH 7.5
Protein Purity
≥ 97% determined by reducing and non-reducing SDS-PAGE analysis
Endotoxin
≤ 0.01 EU/μg using USP <85> / EP 2.6.14
Bioactivity
ED50 is determined by the dose-dependent proliferation of NFS-60 cell cells. The ED50 is typically less than 10 ng/mL. The international units of CTGrade GMP rh M-CSF is approximately 1.02 x 105 IU/μg calibrated against recombinant Human Macrophage colony-stimulating factor WHO International Standard (NIBSC code 89/512).
Quality
Carrier-free and no animal- or human-derived materials were used during manufacturing
Specifications
Storage
This product is shipped at ambient temperature. Immediately upon receipt, store the lyophilized protein at -20°C in a manual defrost freezer.
Shelf Life
Unopened vials are stable for 36 months from the date of manufacture as indicated on the label. Reconstituted material should be apportioned in working volumes and stored at or below -20°C in manual defrost freezer. For short term storage reconstituted material is stable for 4-6 weeks when stored at 2-8°C. Stability can be increased by adding at least 0.1% carrier protein.
