UltraGRO™-PURE GMP grade
Product Type:Fibrinogen depleted cell culture supplement
Attribute:Xeno-free
Grade:GMP grade
Product Name:UltraGRO™-PURE
Catalog Number:HPCHXCGL50, HPCHXCGL10, HPCHXCGL05
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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.
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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
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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.
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Packaging Information:
500mL, 100mL, 50mL plastic bottles
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Media Form:
Frozen Liquid
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Application:
For human ex-vivo tissue and cell culture processing applications.
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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.
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Cell Lines:
bone marrow mesenchymal stem cells, bdipose tissue derived mesenchymal stem cells, umbilical cord derived mesenchymal stem cells, other mesenchymal stem cells
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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.
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Safety information:
1. Follow the handling instructions outlined in the Material Safety Data Sheets (MSDSs). Wear appropriate protective eyewear, clothing, and gloves.
2. UltraGRO™-PURE 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.
3. This product is manufactured, tested and released in compliance with the relevant GMP guidelines. This product is for ex-vivo use only.
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US FDA Drug Master File:
UltraGRO™-PURE has filed a Type II Drug Master File (DMF). Please contact sales@atcbiomed.com for further information.
