BioCina and NovaCina Forge Strategic Alliance to Offer Biologics Developers Integrated Drug Substance and Drug Product Solutions

Written by PR Newswire

ADELAIDE, South Australia, and PERTH, Western Australia, Feb. 27, 2024 /PRNewswire/ -- BioCina Pty Ltd., a global end-to-end biologics Contract Development and Manufacturing Organisation (CDMO), and NovaCina Pty Ltd., a global fill-and-finish CDMO, announced a strategic partnership to provide integrated drug substance and drug product solutions for biologics developers. This alliance enables BioCina to offer the highest quality fill-and-finish solutions to their clients, to convert the drug substance produced at its state-of-the-art Adelaide, South Australia facility into ready-to-use drug product at NovaCina's advanced facility in Perth, Australia. This collaboration marks a significant milestone in providing end-to-end biopharmaceutical manufacturing solutions to clients worldwide.

BioCina ^[1] delivers highest quality, cost-effective CDMO services, including cell line development, process development, and cGMP drug substance manufacturing for the microbial, pDNA and mRNA modalities.

As a result of this partnership, BioCina's clients can benefit from NovaCina's decades of clinical and commercial fill-and-finish experience, backed by numerous regulatory approvals, including from the U.S. Food and Drug Administration (FDA). NovaCina offers a comprehensive suite of services, including development, manufacturing, packaging, labeling, and stability studies.

BioCina's Chief Executive Officer & member of NovaCina Board of Directors, Mark W. Womack said, "BioCina is excited to partner with NovaCina, integrating our globally recognized expertise in clinical and commercial process development and drug substance manufacturing with their esteemed drug product services. This partnership promises to deliver unparalleled quality, adherence to the highest regulatory standards, and on-time delivery of client programs, setting a new benchmark in the market."

NovaCina's ^[2] Chief Executive Officer, Cyrus K. Mirsaidi stated, "We are very excited to form this partnership with BioCina. Together, we provide a seamless end-to-end offering. At NovaCina, we are delighted to bring our world-class quality and safety to this value-adding collaboration."

About BioCinaBioCina is a global end-to-end biologics Contract Development and Manufacturing Organisation (CDMO) of choice, offering high-quality, cost-effective cell line development, process development and cGMP clinical & commercial manufacturing for the microbial, pDNA and mRNA modalities. Our US FDA, EMA and TGA approved site in South Australia, which was previously a Pfizer facility, is staffed with a tremendously experienced technical and operations team, with most critical SME's having an average tenure of 15+ years at the Adelaide site. To address the ever-evolving requirements of our current and future clients, we are adding a 2000 L microbial fermenter and large-scale mRNA manufacturing in our Adelaide facility, and we will be establishing a second facility with Mammalian PD and large-scale manufacturing.To learn more visit https://biocina.com ^[3].

About NovaCinaNovaCina is an independent CDMO delivering sterile injectables with exceptional quality, safety, and on-time delivery. NovaCina has an impeccable 30+ year history with global regulatory approvals including US FDA, TGA and ANVISA, originating from previous Pfizer (Perth) Pty Ltd ownership. Located in Western Australia, NovaCina is recognised for its expertise in development and manufacture of aseptic and terminally sterilised injectables in plastic and glass, and blow-fill-seal presentations, as well as safe handling and filling of cytotoxic products. The 34000M² facility houses nine production lines across Blow-Fill-Seal, High Potency / Oncology, and Specialty manufacturing streams supported with best-in-class analytics and technical services capabilities.

To learn more visit https://www.novacina.co ^[4].

BioCina Contact DetailsBioCina Pty Ltd.8 Dalgleish St, Thebarton, Adelaide, South Australia 5031Kamal Preet, VP Business Development and Marketingkpreet@biocina.com ^[5]AUS: +61 452 625 977

NovaCina Contact DetailsNovaCina Pty Ltd.15 Brodie-Hall Dr, Bentley, Perth, Western Australia 6102Jenny Bourbieljenny.bourbiel@novacina.co ^[6] AUS: +61 893 620 666

Media ContactCasey Keskec.keske@biocina.com ^[7]