产品资料

Helios/UltraGRO™-Advanced GI GMP grade/HPCFDCGLI50, HPCFDCGLI10, HPCFDCGLI05

Overview
Application
Safety Information
Ph.Eur / PMDA

Description:

UltraGRO™-Advanced GI cell culture supplement is a gamma irradiated viral inactivated, fibrinogen depleted, non-xenogeneic, animal serum-free media supplement for replacing FBS (fetal bovine serum) to support cell expansion from research through clinical trials to commercial use. UltraGRO™-Advanced GI contains abundant growth factors and cytokines necessary for research or industrial cell growth and proliferation of multiple cell types (e.g. MSCs).

Specification:

1. Appearance: Yellow to Buff liquid2. Total Protein: 4.0 - 8.0 g/dL3. pH: 6.5 - 8.54. Osmolality: 275 - 355 mOsm/Kg5. Endotoxin: ≤ 10 EU/mL6. Mycoplasma: Not Detected7. Sterility: No Growth8. Performance Test: Test and record9. Fibrinogen: < 20="">8. Gamma Irradiation Dose: 25~40 kGy

Packaging information:

UltraGRO™-Advanced GI is most stable when stored frozen until needed. The recommended storage temperature is -20°C or -80°C. Thaw frozen UltraGRO™-Advanced GI product in 37°C water bath before use. Once UltraGRO™-Advanced 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:

Liquid

Application:

For human ex-vivo tissue and cell culture processing Instructions for uses.

Instructions for Use:

1. UltraGRO™-Advanced 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™-Advanced 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™-Advanced 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™-Advanced GI, it is recommended to centrifuge at 3,400 xg for 3~5 minutes.3. Filtering the completed medium (e.g. 5%), after UltraGRO™-Advanced GI is diluted in the basal medium, will not affect UltraGRO™-Advanced GI supplemented cell culture performance. However, 0.22 μm filtering is NOT recommended for the 100% UltraGRO™-Advanced GI concentrate, as this may reduce 5% UltraGRO™ -Advanced 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™-Advanced 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™-Advanced 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.

European Pharmacopoeia General Chapter 5.2.12.4:

UltraGRO™-Advanced GI have been manufactured under GMP procedures and in line for European Pharmacopoeia General Chapter 5.2.12.4.

Pharmaceuticals and Medical Devices Agency:

UltraGRO™-Advanced GI have received Japan PMDA Certificate.

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Helios/UltraGRO™-Advanced GI GMP grade/HPCFDCGLI50, HPCFDCGLI10, HPCFDCGLI05