1.Why use HELIOS product line as an alternative to FBS?
Answer: HELIOS product line is a supplement for cell culture that contains a natural mixture of human growth factors including; PDGF, bFGF, EGF, TGF-beta1, VEGF, other cytokines and proteins which yield superior results when culturing many types of human cells, particularly human MSC, regardless of their tissue source. The future of cell therapy is to be xenogeneic-free and UltraGRO™ products offer xenogeneic-free/serum substitutes for replacing FBS and improving your cell culture processes.
2. What does the cost of HELIOS product line compare to FBS?
Answer: FBS is commonly used at 10~20% concentration in cell culture for MSC expansion and HELIOS product line is typically used at 5% concentration, or 1/4th of the volume of FBS used. So when you compare cost, you should therefore compare HELIOS product line to 2-4X your current FBS cost. Please see product information.
3. What MSCs have been tested with HELIOS product line?
Answer: HELIOS product line has been tested internally on cultivation of human bone marrow derived, adipose tissue derived, and umbilical cord derived MSCs. Our customers and other recent research publications also demonstrate that HELIOS product line will work well for human amniotic and cord blood derived MSCs.
4. Why does HELIOS product line require heparin to be added into the cell culture?
Answer: Heparin is an anti-coagulant that prevents the fibrinogen in human platelet lysate from clotting in the cell culture medium during cell expansion. Porcine-derived heparin has been an FDA approved drug for injection into humans for over 30 years. Therefore, from a safety and regulatory perspective, there should be no concern about adding small amounts of heparin into cell culture medium for expanding cells for research or cell therapy production.
5. Why do I see precipitate or particulate matter in HELIOS product line?
Answer: The presence of particulate matter is a result of fibrinogen converting to insoluble fibrin resulting from freezing and thawing human platelet lysate. This particulate matter does not indicate contamination of any sort, and does not have any negative impact on cell culture performance. To avoid particulate matter from forming, we suggest minimal freeze / thaw cycles when using HELIOS product line. For optimal results when using HELIOS product line, please follow the "Tips for Using UlraGRO™/ UlraGRO™-Advanced/ UlraGRO™-PURE/ UlraGRO™-Advanced GI/ UlraGRO™-PURE GI to Grow Mesenchymal Stem Cells" provided from Helios.
6. How and where is HELIOS product line processed?
Answer: HELIOS product line is manufactured in our Atlanta, GA facility from human platelet units obtained from FDA-registered or HC-registered blood banks in North American. Donors are carefully selected, platelets are fully screened by the blood banks, and then processed by Helios’ proprietary methods and stringent quality standards, then passed through a 0.2 μm filter to produce and fill a sterile bottled product. HELIOS product line release criteria include testing for endotoxin, mycoplasma and sterility. A Certificate of Analysis (CoA) is provided with each product shipped from every production lot.
7. Is a GMP-grade HELIOS product line available?
Answer: Yes. HELIOS product line is available as a GMP product. As regulatory requirements for ancillary materials differ from region-to-region, it is best to discuss your GMP needs with Helios prior to purchasing GMP HELIOS product line.
8. How long can frozen HELIOS product line be stored?
Answer: HELIOS product line is stable for 2.5 years from the date of manufacture when stored properly at -20°C. Uninterrupted frozen storage at -20°C for 2.5 years does not decrease HELIOS product line performance in cell culture. However, interrupted storage or storage at higher temperatures may affect results. We anticipate that our ongoing studies will indicate that the shelf life of HELIOS product line is longer than 2.5 years.
9. What other cell types can be grown in HELIOS product line?
Answer: HELIOS product line has been used for culturing natural killer (NK) cells, cytokine-induced killer (CIK) cells, and CD3⁺CD8⁺ T cells with success. Third party publications have reported replacement of FBS and serum-free supplements with hPL for successful expansion of other cell lines, including: fibroblast, CHO cells, corneal epithelial cells, endothelial cell lines, and some cancer cell lines (such as K562, Jurkat, HeLa, and MCF-7)
10. Has HELIOS product line been used for clinical trials?
Answer: Yes, there are several clinical trials using HELIOS product line as ancillary material (p.6,11). Also we have two publication that using UltraGRO™ for UCM MSC 3D culture with microcarrier, and for corneal epitheliotropic abilities study (2017). Other than that, Drug Mater Files (DMFs) for UlraGRO™-Advanced, UlraGRO™-PURE, and UlraGRO™-PURE GI are registered with the U.S. FDA.
11. Has UlraGRO™-Advanced GI/ UlraGRO™-PURE GI undergone pathogen-reduction-treatment?
Answer: Yes, gamma irradiation in our GI series achieved more than 4 log10 reductions of viral titers in all four model viruses (DNA/RNA, Envelope/non-Envelope), demonstrating our gamma process is a robust/effective PRT (Pathogen Reduction Treatment).