AventaCell BioMedical Corp. ("AventaCell") is among the world leaders devoted to developing novel human-derived products for use in cell culture and tissue regeneration. Helios Bioscience is AventaCell's product family brand for their products to be used in cell culture and tissue regeneration. AventaCell technologies used in the Helios Bioscience line offer new human-derived solutions for use in translational research of cell and tissue-based therapies to meet the need for animal serum-free cell expansion and production. The demand for safe, efficient and cost-effective cell expansion and production is rapidly increasing with the growth in cell therapy and regenerative medicine research and clinical development. Helios Bioscience products are designed to support expansion and production of a broad range of cells including mesenchymal stem cells and multiple immunocell lines. AventaCell is committed to providing animal serum-free products to accelerate the research, development and commercialization of safe and efficacious cell and tissue-based therapeutics.

UltraGRO™-PURE GI GMP grade

관리자
2022-04-25
조회수 159

 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


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 from research through clinical trials to commercial use. UltraGRO™-PURE GI contains abundant growth factors and cytokines necessary for research or industrial cell growth and proliferation of multiple cell types (e.g. MSCs).


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

8. Gamma Irradiation Dose: 25~40 kGy


Storage and Shipping Information:

UltraGRO™-PURE GI is most stable when stored frozen until needed. The recommended storage temperature is -20°C or -80°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 or -80°C.


Packaging Information:

500mL, 100mL, 50mL


Media Form:

Liquid


Application:

For human ex-vivo tissue and cell culture processing applications.


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.


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™-PURE GI cell culture supplement. Published research has show 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.

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 they will cause an increase in insoluble precipitates and resulting potential decrease in UltraGRO™-PURE GI 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™-PURE GI is a cell culture supplement derived from human platelets collected from healthy donors at FDA or HC licensed blood centers. Each donor has been tested using FDA/HC-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 sound 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.


Drug Master File:

UltraGRO™-PURE GI have filed a Type II Drug Master File (DMF) to the Food and Drug from US FDA and has been issued. We have a Drug Master File for UltraGRO™-PURE GI on record with the FDA that is referenceable.European Pharmacopoeia General Chapter 5.2.12.4:UltraGRO™-PURE GI have been manufactured under GMP procedures and in line for European Pharmacopoeia General Chapter 5.2.12.4.Pharmaceuticals and Medical Devices Agency:UltraGRO™-PURE GI have received Japan PMDA Certificate.

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