A Broome-based startup with a pearler of an invention for treating bone trauma has taken a major step in its commercialisation journey with the opening last week of a biotech manufacturing facility in the northern WA town.
Co-founded by orthopaedic scientist Professor Minghao Zheng and marine biologist Patrick Moase through a commercial collaboration with the University of Western Australia, as well as Willie Creek Pearls chairman Robert Banfield, Marine Biotech aims to transform pearl shell from the local waters into an approved medical product for sale globally.
Utilising the patented technology PearlBone invented by Zheng and Dr Rui (Chris) Ruan at the University of Western Australia, Marine Biotech is spearheading a biomedical enterprise in the Kimberley with its mission to manufacture synthetic material as a bone substitute in orthopaedic trauma medicine and reconstructive surgery.
Derived from the nacre (mother of pearl) of Broome’s silverlipped pearl oyster, the innovative technology harnesses the natural process of mollusc biomineralisation to encourage bone formation in humans.
As well as providing a sustainable source of bone grafting material, PearlBone could help address the global shortage of implant materials for a range of orthopaedic conditions, partially resulting from humans living longer. More than two million bone grafts are performed globally each year.
Marine Biomedical’s long-term goal is to commercialise medical products sourced entirely from the by-products of sustainably certified fisheries.
The facility, officially opened last week, includes a state-of-the-art Good Manufacturing Practice (GMP) cleanroom, analytical laboratory, packaging area and offices. This will allow Marine Biomedical to manufacture PearlBone to the highest quality standards required for approval from the US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA).
Five staff are now working at the facility and will be producing batches of the product to undergo quality and safety assessment and eventual use for treatment of patients with fractures.
"The full-scale batch production during the remainder of 2023 will enable a formal submission to the US FDA for use in humans,” said Marine Biomedical co-founder and CEO Patrick Moase.
"We are completely focused on our pathway to regulatory approval for this remarkable medical product, which has been proven to support new bone growth and has the potential to deliver extraordinary long-term benefits across a range of orthopaedic applications."
Western Australian Minister for Innovation and the Digital Economy; Science and Medical Research, Stephen Dawson, formally opened the new facility, claiming its presence would elevate regional research and innovation capabilities, demonstrating opportunities available in the Kimberley.
"This manufacturing facility will not only position Marine Biomedical and Broome as an international trailblazer in the marine-derived biomedical sector, but the State Government believes it will inspire other businesses and investors to pursue the many opportunities available in our regional areas,” said Minister Dawson.
Marine Biomedical’s commitment to the manufacturing facility has been supported by Western Australian and Federal Government grants that have expedited the establishment of the Broome operation.
Get our daily business news
Sign up to our free email news updates.