UltraGRO™-PURE GI GMP grade
Product Type:Gamma irradiated FDhPL
Attribute:Xeno-free
Grade:GMP grade
Product Name:UltraGRO™-PURE GI
Catalog Number:HPCHXCGLI50, HPCHXCGLI10, HPCHXCGLI05
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Description:
UltraGRO™-PURE GI cell culture supplement is a gamma irradiated viral inactivated, fibrinogen depleted, xeno-free media supplement for replacing FBS (fetal bovine serum) to support cell expansion in research, clinical trials and commercial applications. UltraGRO™-PURE GI contains abundant growth factors and cytokines necessary for 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
10. Gamma Irradiation Dose: 25~40 kGy
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Storage and Shipping Information:
UltraGRO™-PURE GI is most stable when stored frozen until needed. The recommended storage temperature is -20°C. Thaw frozen UltraGRO™-PURE GI product in 37°C water bath before use. Once UltraGRO™-PURE 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.
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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 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™-PURE GI 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, adipose 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 GI. Published research has shown that particles will not alter the performance of the product.
2. Insoluble particles may form in thawed UltraGRO™-PURE GI, it is recommended to centrifuge at 3,400 xg for 3~5 minutes to remove particles prior to use.
3. Filtering the completed medium (e.g. 5%), after UltraGRO™-PURE GI is diluted in the basal medium, will not affect UltraGRO™-PURE GI supplemented cell culture performance. However, 0.22 μm filtering is NOT recommended for the 100% UltraGRO™-PURE GI concentrate, as this may reduce 5% UltraGRO™-PURE GI cell culture performance.
4. Repeated freeze-thaw cycles should be avoided as this will cause an increase in insoluble precipitates and resulting potential decrease in UltraGRO™-PURE GI 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 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 testing 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 in vitro use only.
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US FDA Drug Master File:
UltraGRO™-PURE GI has a Type II Drug Master File (DMF) with FDA. Please contact sales@atcbiomed.com for further information.
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European Pharmacopoeia General Chapter 5.2.12.4:
UltraGRO™-PURE GI has been manufactured under GMP and is compliant with European Pharmacopoeia General Chapter 5.2.12.4.
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Japan Pharmaceuticals and Medical Devices Agency:
UltraGRO™-PURE GI has received a Japan PMDA Certificate.