Cytiva Life Sciences™ Hyclone™ 100 mL Defined Fetal Bovine Serum (FBS), New Zealand Origin

Description

• Our highest quality FBS, HyClone™ NZ-origin Defined FBS is proprietary serial 40 nm-filtered, virus-tested to 9 CFR standard, and supplied with an extensive biochemical profile
• Well-defined: assay results for over 50 components, with additional testing available
• NZ origin: sourced and processed in New Zealand with complete traceability to origin
• Ultra-low endotoxin: 5 EU/mL endotoxin for reduced research and production risk
• Sterile-filtered: Proprietary serial 40 nm filter process
• Virus-tested: broad virus panel testing in accordance with 9 CFR 113.53
• Fetal bovine serum (FBS) is a nutrient-rich cell culture supplement that is high in growth factors and low in antibodies, compared to non-fetal sera
• HyClone™ Defined FBS is widely used by cell culturists who have a concern for viral contaminants and require an extensive biochemical profile
• The final serum is assayed for over 50 components, including proteins, hormones, growth factors, metabolites, and nutrients important for cell culture
• Assay results are included in the certificate of analysis and the biochemical assay list
• Additional testing, including EMEA conformance testing, is also available
• Exceptionally low endotoxin levels Endotoxin contamination is a significant concern when producing cell culture-derived products for use in humans or animals
• The presence of endotoxin in cell cultures can also have adverse and unpredictable effects on cell growth, function and phenotype that can compromise research results
• Our patented closed-system blood collection method and rigorous quality control testing ensure that HyClone™ defined FBS contains ≤ 5 EU/mL endotoxin and ≤ 15 mg/dL hemoglobin
• Low hemoglobin levels in the final product are an indication that extensive cell lysis has not occurred, confirming that the fetal blood has been handled appropriately during collection and transport
• Virus-tested and quality-assured for reduced contamination risk HyClone™ Defined FBS is filtered through proprietary serial 40 nm (0.04 μm) pore size-rated filters, which are the most retentive filters used in commercial FBS production
• This type of filtration is practical in reducing risk while maintaining high performance in cell growth
• Studies demonstrate that this filtration regimen has no adverse effect on cell growth
• Before dispensing, each lot of serum is pooled using true pool technology to ensure uniformity and consistency between bottles
• The final serum is virus-tested according to 9 CFR 113.53 to demonstrate that there are no detectable levels of specified viruses, pathogenic agents, and hemadsorbing agents
• Robust sterility testing further confirms that the final product contains no detectable growth of bacteria or fungi (current USP) and no detectable mycoplasma
• Post-filtration treatments for added process security Gamma-irradiated and heat-inactivated FBS options are available to further reduce the risk of adventitious agents, particularly when manufacturing products for use in humans or animals
• The irradiation process is validated to deliver multiple validated dose ranges starting at 25 kGy
• Regulatory and supply chain security For decades, Cytiva's HyClone™ premium bovine serum products have exceeded industry standards for quality, purity, and regulatory compliance
• HyClone™ serum processes are traceability-certified by the International Serum Industry Association (ISIA)
• In addition, Cytiva has chosen to be an early adopter of scientific traceability by Oritain™ to prove the country of origin of their premium bovine serum products from the United States, Australia, and New Zealand
• Premium bovine serum samples from different regions have been analyzed and Oritain has created a database of the unique ‘Origin Fingerprint’ that is exclusive to each country of origin