NovaCina Expands Perth Facility to Offer Clinical Supplies Service for Global Market
NovaCina recently announced the expansion of its facility in Perth, Australia with the introduction of a high-tech SA25 GMP filling line to assist customers with small-batch sizes suitable for all clinical phases.
From November 2024 onwards, NovaCina’s customers will benefit from having clinical, development and manufacturing services under one roof – a unique proposition in the Global CDMO marketplace. The robotic SA25 GMP filling line can manufacture small batches of vials, PFS (pre-filled syringes) and cartridges under fully aseptic conditions. The new filling line will be compliant with Annex 1 guidelines for the manufacture of sterile medicinal products, issued by the European Union. The batch sizes can range from 0.5 L to 500 L, and accommodate fill volumes from 0.5 mL to 30 mL for glass vials and PFS.
Pete Bullard, Senior Vice President of Manufacturing at NovaCina, said “NovaCina will be one of the first CDMOs in the ANZ market to offer clinical manufacturing services alongside our usual capabilities. The expansion of our facility in Perth will guarantee that our customers are supported through every milestone of their drug development journey. Offering manufacturing capabilities for the clinical phase will also eliminate the need for tech transfer in the future, which can be costly and time-consuming.”
The new fill/finish line will increase NovaCina’s capacity to 5 million+ units per year. Alongside the new line, NovaCina is also planning to increase its capacity in other areas to meet the growing demand in the biologics market. The company is investing as it anticipates increased demand from drug developers seeking to take advantage of the benefits of Australia Government financial incentives offset for R&D entities. The scheme means that R&D and manufacture of new drugs is often up to 60% less expensive than in the US.
Bullard continued “As part of our growth strategy, NovaCina plans to further expand its capacity for blow fill seal. We are also looking to increase our biologic capabilities to ensure we can further support our customers in the future.”
NovaCina is a contract development and manufacturing organization delivering sterile drug products with exceptional quality, safety, and on-time delivery. Based in Perth, Australia, the facility has a 50+ year history manufacturing over 600 products, with global regulatory approvals from 7 health authorities including FDA, TGA, and ANVISA. NovaCina specializes in the manufacture of aseptic and terminally sterilized products in plastic and glass vials, blow-fill-seal presentations, pre-filled syringes and cartridges, as well as, safe handling and filling of cytotoxic and controlled substances. The 34,000m2 facility houses ten production lines supported with best-in-class analytics and technical services capabilities for a production capacity exceeding 220 million units. NovaCina is wholly owned by the Bridgewest Group, who acquired the plant from Pfizer in 2024, followed by the launch of NovaCina as a CDMO serving a global customer base. For more information visit: www.novacina.com
Total Page Views: 259
