Sera Processing
Using industry leading techniques, blood is aseptically collected at abattoirs, centrifuged to isolate the serum and immediately frozen for testing and further processing. The raw sera is then true pooled and is triple 0.1 micron sterile filtered with a Sterility Assurance Level (SAL) of 10-3. Every lot then must pass USP <71> and EP 2.6.1 sterility testing, growth promotion testing, as well as test negative for mycoplasma and number of industry-monitored viruses. Authenticity of the serum is verified using industry leading measurements of Gamma-Glutamyl Transferase and Corning’s high internal standard of ≤ 10 IU/L. Additional testing includes endotoxin, hemoglobin, pH, osmolality, total protein, and a biochemical profile that contains various metals, proteins, hormones and other metabolites.
Quality and Regulatory
- ISO 13485 Certified Quality Management System
- Manufacturing in a cGMP compliant facility operating under 21 CFR 820, Quality System Regulation for Medical Device Manufacturers
- Supply chain is certified for traceability by the International Serum Industry Association (ISIA)
- Every lot is country-of-origin verified using chemical fingerprinting by Oritain™
- Validated irradiation protocols
- Certificates of Suitability (CEP) from the European Directorate for the Quality of Medicines (EDQM) for US origin and Australian origin FBS
We offer FBS from various countries of origin for both Regular and Premium grade to meet your product demands:
Regular FBS is derived from government inspected abattoirs from countries that are USDA safety tested for import into the United States. Most countries are recognized by the World Organization for Animal Health (OIE) as having a negligible risk of Bovine Spongiform Encephalopathy (BSE) and being free from foot and mouth disease (FMD).
Premium FBS is only collected from government inspected abattoirs in the United States, Australia, and New Zealand and derived from healthy bovine cows and heifers that have passed ante- and post-mortem inspection. These countries are recognized by the World Organization for Animal Health (OIE) as having a negligible risk of Bovine Spongiform Encephalopathy (BSE) and being free from foot and mouth disease (FMD).
Product Specifications
| Origin | United States |
| Volume | 500 mL |
| Product Number | 35-015-CV |
| Brand | Corning |
| Shelf Life | 60 months |
| Format | Liquid |
| Species | Bovine, Bos taurus |
| Type | Fetal |
| Sterile | Yes |
| Storage | -40°C to -10°C |
