Products

UltraGRO™-PURE GMP grade

Product Type:FDhPL

Attribute:Xeno-free

Grade:GMP grade

Product Name:UltraGRO™-PURE

Catalog Number:HPCHXCGL50, HPCHXCGL10, HPCHXCGL05

    • Description:

      UltraGRO™-PURE cell culture supplement is a fibrinogen depleted, xeno-free supplement for replacing FBS (fetal bovine serum) to support cell expansion from research and clinical trials to commercial use application.UltraGRO™-PURE 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

    • Storage and Shipping Information:

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

    • Instructions for Use:

      1. UltraGRO™-PURE 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 has been fibrinogen-depleted and does not require the addition of heparin in the cell culture media.

    • Cell Lines:

      bone marrow mesenchymal stem cells, bdipose 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. Published research has shown that particles will not alter the performance of the product.

      2. Insoluble particles may form in thawed UltraGRO™-PURE, it is recommended to centrifuge at 3,400 xg for 3~5 minutes.

      3. Filtering the completed medium (e.g. 5%), after UltraGRO™-PURE is diluted in the basal medium, will not affect UltraGRO™-PURE supplemented cell culture performance. However, 0.22 μm filtering is NOT recommended for the 100% UltraGRO™-PURE concentrate, as this may reduce 5% UltraGRO™ -PURE 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 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™-PURE 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 ex-vivo use only.

    • US FDA Drug Master File:

      UltraGRO™-PURE has filed a Type II Drug Master File (DMF). Please contact sales@atcbiomed.com for further information.