Company partners with supplier to provide a long-term supply of cGMP quality, consistent, characterized FBS via an exclusive Australian source

SAN DIEGO – 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.

The company saw a need in the market for a higher quality FBS that better met the needs of scientists. Traditionally, most sellers of FBS source their raw material under multiple short-term supply agreements which may yield product inconsistencies and fluctuations in availability and price. Thus, FBS has turned into a volatile commodity.

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, quality and long-term price stability. To accomplish this, Nucleus Biologics partnered with Tavistock Group, as well as Australian Agricultural Company (AACo), as its exclusive source. AACo, one of Australia’s oldest companies, has the largest herd in Australia and over 16 million acres of land under its control.

Nucleus Biologics’ supply chain yields an FBS that increases consistency across lots, has Farm-to-FlaskTMtraceability back to the animal, and allows for longer-term pricing arrangements. To demonstrate product consistency, Nucleus Biologics FBS is characterized with 59 tests that include biochemical, hormonal, viral and functional profiles. With a dedicated source from within Australia, Nucleus Biologics ensures an FMD- and BSE-free product.

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.”

About Nucleus Biologics

Nucleus Biologics is a San Diego-based supplier of premium cell culture products for biotech and pharmaceutical companies throughout North America. The company feeds scientific breakthrough by partnering with the source and redesigning the traditional cell culture products supply chain for greater transparency and superior quality. Nucleus Biologics’ premier product offering is an exceptionally low-viral load, Australian-based fetal bovine serum (FBS) that is consistent, traceable to a single source, characterized and provides stable supply and pricing. Numerous other product offerings are planned throughout 2017. Visit us on Facebook, LinkedIn, Twitter, and at nucleusbiologics.com.