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UltraGRO™-Advanced GMP grade

Product Type:Fibrinogen depleted cell culture supplement

Attribute:non-xenogeneic (original material)

Grade:GMP grade

Product Name:UltraGRO™-Advanced

Catalog Number:HPCFDCGL50, HPCFDCGL10, HPCFDCGL05

• Description:

  UltraGRO™-Advanced cell culture supplement is a fibrinogen depleted, non-xenogeneic (original material), animal serum-free supplement for replacing FBS (fetal bovine serum) to support cell expansion from research and clinical trials to commercial application. UltraGRO™-Advanced 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.

• Quality Control Test:

  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™-Advanced is most stable when stored frozen until needed. The recommended storage temperature is -20°C. Thaw frozen UltraGRO™-Advanced product in 37°C water bath before use. Once UltraGRO™-Advanced 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™-Advanced 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 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. Published research has shown that particles will not alter the performance of the product.

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

    3. Filtering the completed medium (e.g. 5%), after UltraGRO™-Advanced is diluted in the basal medium, will not affect UltraGRO™-Advanced supplemented cell culture performance. However, 0.22 μm filtering is NOT recommended for the 100% UltraGRO™-Advanced concentrate, as this may reduce 5% UltraGRO™ -Advanced 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 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 is a cell culture supplement collected from healthy donors at FDA licensed 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.

  US FDA Drug Master File:

  UltraGRO™-Advanced has filed a Type II Drug Master File (DMF).

  注意：所有产品“仅用于非临床科研用途，不用于诊断、治疗、临床或其他用途”！

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