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NovaCina expands Perth facility with new SA25 GMP filling line

Manufacturing and Engineering

Business Honor
10 July, 2024

NovaCina expands its Perth facility with a new SA25 GMP filling line to support small-batch production.

NovaCina, the leading Contract Development and Manufacturing Organization (CDMO), continues to expand its Perth facility with the installation of a new SA25 GMP filling line. The new line will be used for small-batch production of various products, including vials, pre-filled syringes (PFS), and cartridges, encompassing all clinical phases under fully aseptic conditions. Clinical, development, and manufacturing services will then be provided at one location starting November 2024.

This means that the robotic SA25 GMP filling line is a product designed to manufacture small batches of products ranging from 0.5 L to 500 L while having fill volumes from 0.5 mL to 30 mL for glass vials and PFS, the features that will definitely be adaptable to the European Union's Annex 1 guidelines on the manufacturing of sterile medicinal products.

NovaCina's Senior Vice President of Manufacturing, Pete Bullard, said the facility expansion would place NovaCina as one of the first CDMOs in the ANZ market to provide clinical manufacturing services in addition to existing capabilities. By manufacturing for the clinical phase, NovaCina can avoid future tech transfers, thus saving both cost and time.

The new line will help NovaCina boost its production to more than five million units a year. In addition to the filling line, NovaCina is investing in other parts of its facility to meet the rising demand of the biologics market. NovaCina has been strategically positioned to benefit from the financial incentives the Australian government provides for R&D. These incentives reduce the costs of drug development and manufacturing by as much as 60% compared with the United States.

NovaCina intends to further build up its biologic capabilities and to increase its blow-fill-seal capacity to meet the needs of customers in the future as part of its continuing growth strategy.