UltraGRO™-Advanced GI
UltraGRO™-PURE GI GMP grade
Product Type: Gamma irradiated FDhPL
Attribute: Xeno-free
Grade: GMP grade
Product Name: UltraGRO™-PURE GI
UltraGRO™-PURE GI cell culture supplement is a gamma irradiated viral inactivated, fibrinogen depleted, xeno-free media supplement for replacing FBS (fetal bovine serum) to support cell expansion from research through clinical trials to commercial use. UltraGRO™-PURE GI contains abundant growth factors and cytokines necessary for research or industrial cell growth and proliferation of multiple cell types (e.g. MSCs).
1. Appearance: Yellow to Buff liquid
2. Total Protein: 4.0 - 8.0 g/dL
3. pH: 6.5 - 8.5
4. Osmolality: 275 - 355 mOsm/Kg
5. Endotoxin: ≤ 10 EU/mL
6. Mycoplasma: Not Detected
7. Sterility: No Growth
8. Performance Test: Test and record
9. Fibrinogen: < 20 μg/mL
8. Gamma Irradiation Dose: 25~40 kGy
Storage and Shipping Information:
UltraGRO™-PURE GI is most stable when stored frozen until needed. The recommended storage temperature is -20°C or -80°C. Thaw frozen UltraGRO™-PURE GI product in 37°C water bath before use. Once UltraGRO™-PURE GI is thawed, it is recommended to fully use for completed medium preparation (e.g. 5%) the same day, or to divide it into single-use aliquots and store unused aliquots at -20°C or -80°C.
Packaging Information:
500mL, 100mL, 50mL
Media Form:
For human ex-vivo tissue and cell culture processing applications.
Instructions for Use:
1. UltraGRO™-PURE GI shows optimal growth of MSC at 5% (v/v) in typical cell culture media, i.e. α-MEM, which contains 2mM L-Glutamine as final concentrate.
2. We recommend seeding MSCs at approximately 3x103~6x103 per cm2.
3. UltraGRO™-PURE GI has been fibrinogen-depleted and does not require the addition of heparin in the cell culture media.
Cell Lines:
Bone marrow mesenchymal stem cells, Adipose tissue derived mesenchymal stem cells, Umbilical cord derived mesenchymal stem cells, Other mesenchymal stem cells.
Important Information:
1. Insoluble particles may form in thawed UltraGRO™-PURE GI cell culture supplement. Published research has show that particles will not alter the performance of the product.
2. Insoluble particles may form in thawed UltraGRO™-PURE GI, it is recommended to centrifuge at 3,400 xg for 3~5 minutes.
3. Filtering the completed medium (e.g. 5%), after UltraGRO™-PURE GI is diluted in the basal medium, will not affect UltraGRO™-PURE GI supplemented cell culture performance. However, 0.22 μm filtering is NOT recommended for the 100% UltraGRO™-PURE GI concentrate, as this may reduce 5% UltraGRO™ -PURE GI cell culture performance.
4. Repeated freeze-thaw cycles should be avoided as they will cause an increase in insoluble precipitates and resulting potential decrease in UltraGRO™-PURE GI performance.
Safety Information:
1. Follow the handling instructions outlined in the Material Safety Date Sheets (MSDSs). Wear appropriate protective eyewear, clothing, and gloves.
2. UltraGRO™-PURE GI is a cell culture supplement derived from human platelets collected from healthy donors at FDA or HC licensed blood centers. Each donor has been tested using FDA/HC-licensed tests and found nonreactive for HBsAg, Hepatitis B core antibody (anti-HBc), HIV antibody (anti-HIV-1/2), Hepatitis C antibody (anti-HCV), HTLV-1/2 antibody (anti-HTLV-1/2), Trypanosoma cruzi antibody (anti-T. cruzi), HIV-1, HCV, HBV, WNV nucleic acid testing and Syphilis microhemagglutination test. Each donation is tested for ZIKV under either and FDA licensed test or an investigational ID-NAT test and sound non-reactive.
3. This product is manufactured, tested and released in compliance with the relevant GMP guidelines. This product is for in vitro use only.
Drug Master File:
UltraGRO™-PURE GI have filed a Type II Drug Master File (DMF) to the Food and Drug from US FDA and has been issued. We have a Drug Master File for UltraGRO™-PURE GI on record with the FDA that is referenceable.
European Pharmacopoeia General Chapter
UltraGRO™-PURE GI have been manufactured under GMP procedures and in line for European Pharmacopoeia General Chapter
Pharmaceuticals and Medical Devices Agency:
UltraGRO™-PURE GI have received Japan PMDA Certificate.