NovaCina expanded its CDMO 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 onward, NovaCina’s customers will have access to clinical, development, and manufacturing services under one roof, according to the company. The robotic SA25 GMP filling line reportedly can manufacture small batches of vials, PFS (pre-filled syringes), and cartridges under fully aseptic conditions.
The company noted that 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.
“NovaCina will be one of the first CDMOs in the ANZ market to offer clinical manufacturing services alongside our usual capabilities,” said Pete Bullard, senior vice president of manufacturing at NovaCina.
“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 five million+ units per year, continued Bullard. Alongside the new line, NovaCina is also planning to increase its capacity in other areas to meet the demands in the biologics market. The company pointed out that it is investing as it anticipates increased demand from drug developers seeking to take advantage of the benefits of Australian Government financial incentives offset for R&D entities. The scheme means that R&D and manufacture of new drugs are often up to 60% less expensive than in the United States, according to Bullard.
“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.”
