Injecting Industry into Research03 May 2012
AUSTRALIA - These days, bringing new animal vaccines to market requires more than just registering a ‘bug in a bottle’. Strict regulations to ensure food safety, imposed by the Australian Pesticides and Veterinary Medicines Authority and other authorities around the globe, demand rigorous quality controls from vaccine seed to final product. To this end, the Poultry CRC encourages close co-operation between its research organisations and the vaccine companies who will commercialise the ultimate product of CRC vaccine projects.
Towards commercialisation of a next-generation ILTV vaccine is a project which exemplifies this approach, according to Project Leader, Dr Joanne Devlin from The University of Melbourne. “Before proceeding with the safety and efficacy work, it is essential that the vaccine seed used in these studies satisfies specific regulatory requirements.
Therefore, in conjunction with Bioproperties, the vaccine candidate has been re-established as a pre-master seed-lot.” Dr Rima Youil, from Bioproperties, concludes, “this tight working relationship has enabled us to bank down a pre-master seed with a master seed to follow soon. It has been a solid effort by both the university and Bioproperties.”
Building on this solid foundation, the team can go on to deal with the registration steps while making sure the eventual vaccine is commercially viable. As Dr Youil explains: “It is important that manufacture of the live vaccine is optimized so that high titres can be produced to meet the market. Upcoming efficacy trials will confirm dosages which will assist us in testing safety of the vaccine which is conducted at a 10X overdose for live vaccines.” According to Dr Youil, “Bioproperties and The University of Melbourne have successfully co-operated closely during several Poultry CRC projects including the newly registered vaccine for fowl cholera, Vaxsafe® PM.
“This iterative linkage between researchers and commercial partners is key” says the Poultry CRC’s Commercial Manager, Lloyd Thomson. “It’s a crucial part of what makes Cooperative Research Centres, like the Poultry CRC, so good at turning research outputs into real-world outcomes, like better processes, products and services for everyone.”