Clinical batch manufacturing for sterile liquid drug product
50 years of excellence in GMP manufacturing with NovaCina
The demand for clinical trial manufacturing services is on an all-time high with not enough CDMOs to meet the growing GMP demands. To address this issue, NovaCina is in the process of qualifying a SA25 aseptic filling line, to assist you with unparalleled excellence in clinical trial batch manufacturing, and orphan drug commercial production. Our state-of-the-art facility which has been audited by 7 different Regulatory Agencies, is poised to accelerate your path to success in the pharmaceutical landscape.
BioTechs / Pharmaceutical companies often encounter significant hurdles in navigating the complexities of clinical trial batch manufacturing, and orphan drug commercialization. Often, it is not economical for the larger CMOs to manufacture smaller batch sizes on their large filling lines, and therefore they are not keen on allocating manufacturing slots for clinical trial purposes, or for commercial products who have Orphan Drug Status. Getting slots at a realistic price with the larger CMOs can be a challenging task, which can impede the journey towards bringing life-changing therapies to market.
Why choose NovaCina?
The SA25 Filling Line has advanced capabilities for clinical trial batch manufacturing and orphan drug production, offering unmatched precision, flexibility, and scalability. You get to choose from a wide range of primary packaging options – vials, PFS, and soon to be cartridges.
NovaCina has 5 mn+ annual capacity on our soon to be qualified SA25 line. We can offer you preferential manufacturing slots which will allow you to fast track your clinical trials.
Our facility has been successfully audited by 7 Regulatory Agencies, including US FDA, TGA and Europe, which is a testament to our compliance with regulatory requirements and upholding the highest levels of quality and safety throughout the whole process. We currently ship sterile material to 98 countries.
Australia offers a unique balance between stringent regulations and data integrity of the western markets, along with cost benefit for outsourcing to an Ex-US/EU site. Moreover, the Australian Government provides substantial financial incentives to the tune of ~40%, for R&D and Clinical Trials conducted in Australia.
Whether you’re conducting early-stage clinical trials or preparing for commercial launch, our team collaborates closely with you to tailored solutions that meet your specific needs and objectives. Our NovaCina has a dedicated technical transfer team to ensure that your product transfer is accurate and hassle-free.
Leveraging automated processes and rigorous quality control measures, we streamline manufacturing workflows to optimize efficiency, minimize risk, and accelerate time-to-clinic.
Ready to fast track your sterile drug product into the clinic? Schedule a consultation with our experts today and discover how NovaCina can empower your success in clinical trial batch manufacturing and orphan drug commercialization.