Products

UltraGRO™-Advanced GI GMP grade

Product Type:Gamma irradiated FDhPL

Attribute:non-xenogeneic

Grade:GMP grade

Product Name:UltraGRO™-Advanced GI

Catalog Number:HPCFDCGLI50, HPCFDCGLI10, HPCFDCGLI05

    • Description:

      UltraGRO™-Advanced GI cell culture supplement is a gamma irradiated viral inactivated, fibrinogen depleted, non-xenogeneic, animal serum-free  supplement for replacing FBS (fetal bovine serum) to support cell expansion in research and clinical application 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) in research-scale or industrial-scale production.

    • Specification:

      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

      10. Gamma Irradiation Dose: 25~40 kGy

    • Storage and Shipping Information:

      UltraGRO™-Advanced GI is most stable when stored frozen until needed. The recommended storage temperature is -20°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.

    • Packaging Information:

      500mL, 100mL, 50mL plastic bottles

    • Media Form:

      Frozen 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. Published research has shown 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 Packaging 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 licensed blood centers. Each donor has been tested using FDA 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 found 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 has been manufactured under GMP procedures and in line for European Pharmacopoeia General Chapter 5.2.12.4.

    • Japan Pharmaceuticals and Medical Devices Agency:

      UltraGRO™-Advanced GI has received Japan PMDA Certificate.