NovaCina, a global contract development and manufacturing organization (CDMO), has 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, commented on the story: “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.”
