'A lot of people lose the reason why they come to work,' says Nikki Murdoch, global supply-chain manager of bovine serum for GE Healthcare Life Sciences, Australia and New Zealand. But Murdoch and her team of 35 never waver in their purpose, 'to secure the health of our generation'.
GE Life Sciences' bovine-serum processing facility in Tauranga, New Zealand, was last year upgraded to more than double its output of a medical-grade serum known as HyClone, which is distributed to research facilities and drug manufacturers around the world.
Fetal bovine serum (FBS), a blood byproduct of the meat industry, is a critical ingredient of vaccines such as Measles, Mumps and Rubella, in which it nourishes the live cells until they can be delivered. Wherever live cells are being used or researched for use in fighting disease - such as in the evolving class of biopharmaceuticals applied to counter every kind of cancer - FBS provides food for those antibodies in transit from manufacture to patient.
Globally, the top two preferred suppliers of FBS are Australia and New Zealand, because of the health status of the two countries' cattle herds. 'It has to do with our geographical isolation and the regulations we apply to the movement of our animals, and how we protect our borders against incoming disease,' says Murdoch.
Serum from countries with a low risk of mad-cow disease (bovine spongiform encephalopathy) or foot-and-mouth disease (FMD), for example, command a premium with drug companies. Maintaining public trust in medications is paramount, and ensuring that original ingredients are free from contaminants contributes to certainty and confidence in medicine production.
Tauranga's Life Sciences laboratory has been processing New Zealand-sourced serum since the 1980s. Last year, it was upgraded to enable it to also process Australian-sourced serum, thereby improving efficiencies and increasing supply to meet growing demand.
'We are required to ensure that the serum from each source country is kept totally separate,' says Murdoch. But the chemical flushing of lines in between processing sera from each country took prohibitively long, and even then it was hard to certify that no traces of the previous batch remained. The solution was to move to single-use filtering equipment. 'A single-use system reduces days of work and large amounts of chemicals we would have had to apply between batches, and it allowed us to increase the volume going through the site.'
The re-tooled facility and its processes completed validation in December 2017: 'We have to prove sterility of our product, that it is able to be used for its purpose. As part of that we go through a number of validation protocols to ensure that there is no potential for any external bugs or contamination to get into the serum,' explains Murdoch.
Production of Hyclone is part of GE's commitment to provide clinicians with wing-to-wing services that help them make better decisions and more quickly answer questions in the development of vaccines and precision medicines used against cancer, diabetes, AIDS rheumatoid arthritis and blood disorders.
From innovative research tools and analytics for developing therapies, to modular biopharma factories that can set up within 18 months, Life Sciences offers cutting-edge integrated technologies that take customers from development to manufacture with reduced costs and improved productivity at each stage. This should ultimately deliver more cost-effective medications to patients in need.
Says Murdoch, 'All the new genetic sciences that use live cells to fight disease need something to keep those cells alive, and serum is one medium for doing that.'
She adds, 'Because what my team makes can be used to treat members of our families, and families around the world, it's a very personal product. Without access to what we do, our children, our parents, our whole value system could die. What we do saves lives, so we have to do it extremely well.'