In a collaborative effort, global biologics Contract Development and Manufacturing Organisation (CDMO), BioCina Pty Ltd., and NovaCina Pty Ltd., a global fill-and-finish CDMO, have unveiled a strategic partnership. This collaboration facilitates BioCina in delivering top-tier fill-and-finish solutions to clients by transforming the drug substance manufactured at its advanced facility in Adelaide, South Australia, into ready-to-use drug products at NovaCina’s state-of-the-art facility in Perth, Australia. This partnership represents a noteworthy achievement in providing end-to-end biopharmaceutical manufacturing solutions to clients worldwide.
BioCina specializes in providing high-quality, cost-effective CDMO services encompassing cell line development, process development, and cGMP drug substance manufacturing for microbial, pDNA, and mRNA modalities.
The alliance empowers BioCina’s clients to leverage NovaCina’s extensive clinical and commercial fill-and-finish expertise, supported by numerous regulatory approvals, including from the U.S. Food and Drug Administration (FDA). NovaCina offers a comprehensive suite of services covering development, manufacturing, packaging, labeling, and stability studies.
Mark W. Womack, the Chief Executive Officer of BioCina and member of the NovaCina Board of Directors, expressed enthusiasm about the partnership, highlighting the integration of BioCina’s globally recognized expertise in clinical and commercial process development and drug substance manufacturing with NovaCina’s esteemed drug product services. He emphasized the potential of the partnership to deliver unparalleled quality, adherence to the highest regulatory standards, and on-time delivery of client programs, setting a new benchmark in the market.
Cyrus K. Mirsaidi, Chief Executive Officer of NovaCina, conveyed excitement about the collaboration, emphasizing the seamless end-to-end offering created together. He expressed delight in bringing NovaCina’s world-class quality and safety to this value-adding partnership.
About BioCina
BioCina stands as a premier global Contract Development and Manufacturing Organization (CDMO) in the biologics sector. Renowned for its high-quality and cost-effective services, BioCina specializes in cell line development, process development, and cGMP clinical & commercial manufacturing across microbial, pDNA, and mRNA modalities. The South Australia-based facility, formerly owned by Pfizer and now approved by US FDA, EMA, and TGA, boasts a highly experienced technical and operations team. Notably, key subject matter experts at the Adelaide site exhibit an average tenure of 15+ years. In response to evolving client needs, BioCina is expanding its capabilities with the addition of a 2000 L microbial fermenter and large-scale mRNA manufacturing in the Adelaide facility. Furthermore, plans are underway for the establishment of a second facility equipped with Mammalian PD and large-scale manufacturing. For more information, visit [BioCina](https://biocina.com).
About NovaCina
NovaCina emerges as an independent Contract Development and Manufacturing Organization (CDMO) specializing in the production of sterile injectables with a steadfast commitment to exceptional quality, safety, and timely delivery. Boasting a remarkable history spanning over 30 years, NovaCina holds global regulatory approvals, including US FDA, TGA, and ANVISA, stemming from its prior ownership by Pfizer (Perth) Pty Ltd. Strategically located in Western Australia, NovaCina is recognized for its proficiency in developing and manufacturing aseptic and terminally sterilized injectables in plastic and glass, as well as blow-fill-seal presentations. The extensive 34,000m² facility accommodates nine production lines spanning Blow-Fill-Seal, High Potency / Oncology, and Specialty manufacturing streams. The facility is complemented by best-in-class analytics and technical services capabilities.
Source: https://biocina.com/press-releases/biocina-and-novacina-forge-strategic-alliance-to-offer-biologics-developers-integrated-drug-substance-and-drug-product-solutionsbiocina-and-novacina-forge-strategic-alliance-to-offer-biologics-develop/
