Bovine sera is used as a growth medium in mammalian cell culture reactors, used to make biologic drugs, and some of its constituents are used as excipients, There has been a shift towards the use of non-animal derived reagents because of animal welfare issues and the risk that infectious material, and notably transmissible spongiform encephalopathies (TSEs), could get into the final product and infect patients.
However, there is still a demand for bovine media, as the complexity of cell culture and difficulties in identifying exactly which factors in a medium are essential for cell growth means that some cells will not grow well in animal-free sera. This has an impact on recombinant protein yields.
Invitrogen is aiming to get around the TSE risk issue by siting its 1,000 square metre production facility in New South Wales. Australia has become an attractive location to source animal products because it is certified as being free of bovine spongiform encephalopathy or Mad Cow Disease, the TSE of greatest concern for biologic drugs production. It also has a lower incidence of other viral diseases prevalent in other countries.
"While the industry is transitioning to advanced media and animal-free products, there is still a need to support researchers using traditional methodologies and to provide our customers worldwide with a safe, reliable source for these products," said Gregory Lucier, Invitrogen's Chairman and CEO.
Invitrogen said it would continue to review opportunities to expand its operations in Australia, as it expects demand for products derived from animals in this region to grow.
Last year, the European Medicines Agency, in response to the discovery of BSE in North American cattle, concluded that there was no public health concern from animal-derived medicinal materials such as bovine blood derivatives, including albumin, and gelatin. But it also said there may be some regulatory compliance issues for companies sourcing pharmaceutical ingredients from the region.