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™-Advanced GI GMP grade

관리자
2022-04-25
조회수 189


UltraGRO™-Advanced GI GMP grade


Product Type: Gamma irradiated FDhPL

Attribute: non-xenogeneic

Grade: GMP grade

Product Name: UltraGRO™-Advanced GI

Catalog Number: HPCFDCGLI50, HPCFDCGLI10, HPCFDCGLI05


Description:

UltraGRO™-Advanced GI cell culture supplement is a gamma irradiated viral inactivated, fibrinogen depleted, non-xenogeneic, animal serum-free media supplement for replacing FBS (fetal bovine serum) to support cell expansion from research through clinical trials to commercial use. UltraGRO™-Advanced 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


Packaging information:

UltraGRO™-Advanced GI is most stable when stored frozen until needed. The recommended storage temperature is -20°C or -80°C. Thaw frozen UltraGRO™-Advanced GI product in 37°C water bath before use. Once UltraGRO™-Advanced 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


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 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.


European Pharmacopoeia General Chapter 5.2.12.4:

UltraGRO™-Advanced 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™-Advanced GI have received Japan PMDA Certificate.

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