In a significant development for the marine-derived biomedical sector, Marine Biomedical celebrated the official opening of its state-of-the-art biotech manufacturing facility in Broome, Western Australia.
The facility is set to play a pivotal role in transforming locally sourced pearl shell into PearlBoneTM medical products intended for global use in patients requiring trauma and reconstructive surgery. The biotech facility encompasses a Good Manufacturing Practice (GMP) cleanroom, an analytical laboratory, a packaging area, and office spaces, marking a pioneering investment in regional biotech capabilities.
Marine Biomedical’s journey towards regulatory approval for PearlBone in medical applications, with a particular focus on orthopaedics, has been marked by success in pre-clinical trials. The GMP cleanroom ensures the highest quality standards necessary for approval from regulatory bodies such as the US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA).
PearlBone, a patented bone substitute developed by Professor Minghao Zheng and Dr. Rui Ruan at the University of Western Australia, is derived from the nacre (mother of pearl) of Broome’s silver-lipped pearl oyster.
This harnesses the natural process of mollusc biomineralization to stimulate bone formation in humans. Not only does it offer a sustainable source of bone grafting material, but it also addresses the global shortage of implant materials for various orthopaedic conditions.
The Minister for Innovation, Stephen Dawson, was present at the opening.
This manufacturing facility will not only position Marine Biomedical and Broome as an international trailblazer in the marine-derived biomedical sector but also inspire other businesses and investors to explore opportunities in our regional areas.
Stephen Dawson – Western Australian Minister for Innovation and the Digital Economy, Science: Medical Research
The location of the facility in Broome ensures proximity to the sustainable pearl shell resources harvested from the Indian Ocean. Marine Biomedical’s long-term vision is to commercialize medical products entirely sourced from by-products of sustainably certified fisheries.
At present, five specialized staff members are working at the facility, primarily focusing on producing batches of PearlBone for quality and safety assessments, with plans for eventual use in the treatment of patients with fractures.
According to Mr. Patrick Moase, the CEO of Marine Biomedical Pty Ltd, full-scale batch production in the remainder of 2023 will enable a formal submission to the US FDA for use in humans.
“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,” said Patrick.
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