“FBS has been a critical mainstay of cell-based pharmaceutical research and bioproduction for years,” David Sheehan, CEO of the San Diego-based cell culture product supplier told Biopharma-Reporter.com.
“It has literally been the food of the cells used in ground-breaking research and drug development over the last 40+ years.”
But while FBS contains high levels of embryonic growth promoting factors and low levels of antibodies, there are a number of issues well-known to industry in using the serum.
As a by-product of the dairy industry the serum is subject to supply and price inconsistencies, batch-to-batch variability and the risk of bovine disease contamination.
“FBS is still widely used in biomanufacturing because it provides a reliable and low-risk supplement when sourced from quality suppliers,” Sheehan said, urging industry to look for suppliers that have “low viral risk country of origin, strong traceability systems preferably back to the animal, long term source agreements to ensure the product is coming from the same location, and extensive characterization testing.”
As such, Nucleus Biologics now sources its raw materials from Australian Agricultural Company (AACo), a profitable public company which Sheehan said boasts the largest herd in Australia with over 16 million acres.
From there, the FBS is made at an FDA registered, ISO 9001:2008 certified facility and the product is tested for endotoxins and is tetracycline.
“The driver of FBS reliability is really lot to lot consistency, and hence that is why we reengineered our supply chain to minimize biologic variation,” he told us.
“An Australia/New Zealand product has been more desirable because of those countries’ tight control on cattle imports, extensive national RFID [radio frequency identification devices] tracking systems to ensure traceability and lowest possible viral risk.”
Nucleus Biologics is so confident of the quality and consistency of its FBS supply, the firm has said begun offering a two-year, fixed-price guarantee to its customers.
The FBS market is estimated to be worth $750-800m, Sheehan said, but a number of companies have developed alternatives to animal-sourced cell culture media, in the form of human-sourced and xeno(animal)-free systems.
Nucleus Biologics itself, for example, is looking to launch a human-source product that has been under development for the last three years, while firms including Cook Regentec, Irvine Scientific and Evercyte have developed xeno-free media.
“Serum-free systems tend to cost more and are tailored for certain cell lines,” said Sheehan. “The process of training the cells to grow in this specific media and optimising their performance takes time and money. If you have a stable platform, it may, or may not, be worth the money.”
“Human-based supplements have historically had issues with availability. Those supplements tend to be more expensive and unless tightly controlled can have more variation.”