1. Why use MycoFold’s rHu M-CSF?
Our Recombinant Human Macrophage-Colony Stimulating Factor (rHu M-CSF) has been engineered for maximum bioactivity, thermal stability, and ease of use, providing researchers with the best-in-class return on investment for their growth factor or cytokine needs. Our innovation plan starts with sequence optimization using artificial intelligence (AI) and machine learning (ML) tools combined with high-throughput screening methods to identify an optimized protein target with properly positioned binding residues for maximum receptor binding affinity (the engine). Utilizing an engineered P. Pastoris (yeast) expression model (the chassis), which provides mammalian PTMs and chaperoned folding to enable complete 3D protein structures, we can translate optimized protein sequences into functional proteins that overcome current technical challenges such as poor bioactivity, misfolding, lot-to-lot inconsistency, and thermal instability. Our rigorous release testing requirements and documentation ensure that performance and value
expectations are met (see Product Data Sheet and Certificate of Analysis).
2. What are the recommended storage conditions for MycoFold’s
rHu M-CSF?
We recommend storing this product at 2-8°C.
3. What are the shipping conditions for MycoFold’s rHu M-CSF?
This product ships at ambient temperature.
4. What is the shelf-life for MycoFold’s rHu M-CSF?
This product has a shelf life of 24 months after the date of manufacture under recommended controlled storage conditions. See Certificate of Analysis or Product Data Sheet for more information.
5. How do you reconstitute MycoFold’s rHu M-CSF?
Initially reconstitute in deionized water (DI) or water for injection (WFI) to a concentration of 0.3 - 0.5 mg/mL. See Certificate of Analysis for more information.
6. What organism is used to express MycoFold’s rHu M-CSF?
This product is secreted from engineered K. phaffii (fka P. pastoris) yeast.
7. How is MycoFold’s rHu M-CSF different than native M-CSF?
MycoFold’s rHu M-CSF peptide sequence matches the wild-type sequence of native M-CSF, verified by LC-MS.
8. What is the molecular weight of MycoFold’s rHu M-CSF?
MycoFold’s rHu M-CSF was characterized using a high-resolution LC-MS using a Waters™ ACQUITY M-Class NanoLC liquid chromatography platform and a Thermo Scientific™ Orbitrap™ Eclipse Tribrid HRMS mass spectrometry platform and was found to have an observed molecular mass of approximately 18.3 kDa. Every batch of product is also released using a reducing SDS-PAGE molecular weight assay to directly compare against a reference standard.
10. Does this product have a TSE/BSE statement?
Yes, a TSE/BSE statement is available on the rHu M-CSF product website.
11. Are animal-derived materials used in the manufacture
of this product?
No animal-derived materials are used in our manufacturing process. Additionally, this product was manufactured in a fully dedicated animal-free facility. Please see our BSE-TSE Statement for additional information.
12. Is virus and pathogen inactivation included in the
manufacturing process?
No, our expression system, Pichia Pastoris (yeast), is not a natural host for bacteriophages that infect E. coli-based expression systems or human or animal viruses that infect mammalian-based expression systems.
13. What safety testing is done on this product?
Every lot of final product is tested and released, with specifications and methods per USP/EP, for both Endotoxin (USP <85> / EP 2.6.14)and Sterility (USP <71> / EP 2.6.1).
14. Which cell types are suitable?
MycoFold’s rHu M-CSF can be used to promote the activation and proliferation of numerous cell types, including tissue-resident macrophages, tumor-associated macrophages, hematopoietic stem and progenitor cells (HSPCs), mononuclear phagocyte and osteoclast progenitors, microglia, dendritic cells, placentaltrophoblasts, myeloid-derived suppressor cells (MDSCs), and blood-derived monocytes.
15. Do you have an SDS for this product?
Yes, an SDS is available for this product.
16. How does MycoFold measure activity for rHu M-CSF?
MycoFold observed fold induction of the M-NFS-60 cell line (ATCC Cat. No. 30-2001) after dose and time-dependent exposure to MycoFold rHu M-CSF protein, quantitatively assessed by luminescence of PrestoBlue™ Cell Viability reagent. The specific activity of MycoFold™ rHu M-CSF is greater than 3.13 x 10e5 IU/mg, which is calculated against Human M-CSF WHO Standard NIBSC 21/308 and the leading E. coli-based and HEK-293-based competitor versions. See Product Data Sheet for more information.
17. Is the activity performance comparable to competitor rHu M-CSF products?
The specific activity (MIU/mg) of MycoFold’s rHu M-CSF batches has outperformed the leading E. coli-expressed and HEK-293-expressed competitor’s versions of M-CSF. We attribute this performance to the wild-type peptide sequence confirmation of our M-CSF, the consistent lot-to-lot nature of yeast (eukaryotic) expression, and high purity levels of our proteins. In our head-to-head test, the specific activity of MycoFold’s rHu M-CSF was 3.13 x 10e5 IU/mg, compared to 1.63 x 10e5 IU/mg and 2.86 x 10e5 IU/mg from the leading E. coli-based competitor and HEK-293-based competitor versions, respectively.
16. How does MycoFold measure thermal stability for rHu M-CSF?
MycoFold tests the thermal stability of rHu M-CSF using a RT-PCR thermal shift protein assay manufactured by Biotium (Cat. No. 33022-T) to generate a Tm value, which is a measure of temperature-induced unfolding, indicating the temperature at which 50% of a protein population is unfolded. The Tm value for MycoFold’s rHu M-CST is approximately 79.2°C.
18. What is the intended use for the product?
Unless otherwise stated in our catalog or other company documentation accompanying this product, this product is intended to be used as an ancillary material for research purposes and not for unauthorized commercial or therapeutic uses, including resale.
19. What packaging options are available?
MycoFold’s lyophilized rHu M-CSF is available in 6 different aliquot sizes: 1 mg, 500 µg, 250 µg, 100 µg, 50 µg, and 10 µg. All aliquot sizes are packaged in generic colorless polypropylene (PP) screw cap vials that are sterilized before filling. These vials have a nominal fill volume of 2 mL with a minimum overflow volume of 2.4 mL.
20. Do I need to use a sterile needle and syringe to remove the product from the vial?
No, our vial packaging was chosen for easy access with a laboratory pipette.
