The facility, which is adjacent to the site’s manufacturing plant for plasma products, will produce novel recombinant therapies on a scale suitable for international clinical trials.
The first therapy to be manufactured in the new facility will be a novel blood clotting factor (rVIIa-FP) for the treatment of hemophilia. This is one of several longer-acting clotting factors under development by CSL that aims to reduce the number of injections required to maintain normal blood clotting in people with bleeding disorders. Clinical trials of rVIIa-FP in patients are expected to commence later this year in the US, Europe and Australia, where recruitment is ongoing.
“This world-class facility is key to the ongoing success of our global R&D strategy and reflects our commitment to providing better treatment options for people who are managing certain bleeding disorders and other life-threatening conditions,” said CSL CEO Paul Perreault.
The company is developing drugs to treat hemophilia A and B, which it claims are central to its long-term growth plans.
CSL has more recently developed specialist capabilities in recombinant-based research, adding to its expertise in plasma protein therapeutics. CSL’s research and development pipeline currently includes recombinant therapies for a range of rare and serious diseases, including bleeding disorders, inflammatory conditions and cancer.