BioCina

BioCina is a global biologics contract development and manufacturing organisation (CDMO) dedicated to accelerating therapies to market with a client-centric approach.

Based in Adelaide, Australia, BioCina specialises in process development and cGMP manufacturing of microbial, plasmid DNA (pDNA), and messenger RNA (mRNA) products. The company is distinguished by its commitment to quality, regulatory compliance, and industry-leading on-time, in-full delivery. As the only biologics CDMO in Australia approved by the US FDA, BioCina leverages its strategic location to offer clients accelerated timelines to clinical trials and access to Australia's R&D tax incentives.

Key Products and Services:

• Microbial Services: Bacterial protein expression platforms for various microbial products, including whole-cell vaccines.
• Plasmid DNA Services: Process development and bulk cGMP production of DNA adjuvants and plasmids for vaccines, cell and gene therapies, and mRNA templates.
• mRNA Services: Production of mRNA for preclinical research, toxicology studies, clinical trials, and commercial applications in therapeutics and vaccines.
• Technology Transfer: Optimisation of client processes with standardised procedures, robust quality systems, and dedicated project management.
• Process Development: Development of reliable and scalable manufacturing processes across multiple modalities to expedite timelines and reduce costs.
• Analytical Development: Integrated lifecycle services, including method transfer, development, qualification, and validation for microbial, pDNA, and mRNA programmes.
• cGMP Manufacturing: Capacity for scaling from preclinical to commercial manufacturing, ensuring regulatory compliance and operational excellence.
• Quality and Regulatory Services: Compliance with stringent regulatory authorities, providing phase-appropriate quality approaches throughout clinical trials, validation studies, and product approvals.

BioCina's highly experienced teams are dedicated to delivering client programmes on time and in full, maintaining a culture where quality is embedded in every aspect of their services. Their strategic location and regulatory approvals position them as a reliable partner for clients seeking to bring biologic products to market efficiently.