For immediate release
Nucleus Biologics Launches Its First Premium Cell Culture Product – a Best-in-Class Fetal Bovine Serum to Feed Scientific Breakthrough
SAN DIEGO – January 30, 2017 – Nucleus Biologics, a cell culture products supplier to the biotech and pharmaceutical industries, has launched its first premium product – a fetal bovine serum (FBS) that provides customers access to an exclusive source in Australia. This FBS is exceptionally low-viral risk and is ideal for bioproduction or research applications in stem cells, vaccines, antibodies, CAR-T cells, immunotherapies or any sensitive scientific experiments.
Nucleus Biologics believed there was a way to create a new standard and redesign the traditional FBS supply chain to allow greater transparency between the source and the scientist. The company asserts that this process will exceed customer expectations for product consistency and quality.
Nucleus Biologics’ supply chain yields an FBS that increases consistency across lots and has Farm-to-FlaskTM traceability back to the animal. To demonstrate product consistency, Nucleus Biologics FBS is characterized with 78 tests that include biochemical, hormonal, viral and functional profiles.
The FBS is also manufactured under a controlled and transparent process yielding an extremely low viral load, low hemoglobin and low endotoxin serum. Nucleus Biologics also processes its FBS in a facility that is FDA registered, ISO 9001:2008 certified and follows cGMP. The processing facility has years of experience and is regularly audited internally and externally by entities including large pharmaceutical companies.
“We have organized the company by design: to create products that accelerate science by insuring quality at the source,” said Nucleus Biologics Chief Executive Officer David Sheehan. “If you are a scientist, every variable matters in the lab and your choice of FBS can affect your cells whether it’s research on sensitive cell lines or large scale bioproduction of vaccines or antibodies. We are confident our customers will see the benefit of our fundamentally different supply chain. We also have a healthy pipeline of future products and we are looking forward to delivering those to the scientific community.”
According to Assistant Professor and Cancer Biologist Matthew Sikora from the University of Colorado Anschutz Medical Campus, researchers that don’t focus on the quality of FBS could be getting inconsistent results that result in costly experiment delays. Last year, he and others in his laboratory were stalled for about six months when sequential batches of serum failed an initial screen.
“We estimated the cost of the failed experiments at over $45,000 in just personnel and consumables. We think that unrecognized variations in serum might explain why we could not get consistent results,” said Sikora. “Researchers who don't test their serum could run into trouble and risk expensive delays.”