BioCina is a global, end-to-end contract development and manufacturing organisation (CDMO) headquartered in Australia, serving pharma and biotech clients from early clinical development through to commercial supply. With integrated GMP facilities spanning drug substance biologics and sterile fill-finish drug product, BioCina is the leading end-to-end CDMO in Australia.
Drug substance capabilities span microbial fermentation, plasmid DNA (pDNA), mRNA, and lipid nanoparticle (LNP) encapsulation, from cell banking through to purified bulk material at clinical and commercial scale. Drug product capabilities cover the full spectrum of sterile fill-finish for both small molecules and biologics, across multiple presentations including Blow-Fill-Seal (BFS), aseptic vials, prefilled syringes, cartridges, cytotoxic fill-finish, and controlled substance manufacturing.
Trusted by the world's leading regulatory authorities including the US FDA, EMA, TGA, PMDA, and Health Canada, BioCina has supported more than 600 product approvals globally. With an average specialist tenure of 15 years and industry-leading OTIF performance, BioCina offers the agility and flexibility to design programs around each client's needs at every stage of development.
Manufacturing in Australia offers distinct strategic advantages, including a fast clinical trial pathway and a refundable R&D tax offset of up to 43.5% on eligible development expenditure, making BioCina a compelling partner for international sponsors.
Contact
Mr. Jan Bekker
Vice President, Business Development (Drug Substance)
Objectives
- Partner with clinical-stage and commercial biotech and pharma companies seeking integrated drug substance and drug product manufacturing across biologics and small molecules
- Engage mRNA, pDNA, and gene therapy developers requiring GMP manufacturing and integrated fill-finish under a single project team
- Connect with oncology, rare disease, and orphan drug companies requiring high-containment cytotoxic fill-finish or flexible small-batch biologics supply
- Support specialty and hospital pharma, generic manufacturers, and controlled substance companies seeking high-volume or specialist sterile fill-finish capabilities
- Engage established pharmaceutical companies looking to derisk their supply chain, access specialist capabilities, or establish a second source
- Build relationships with CMC consultants, regulatory advisors, and outsourcing professionals who recommend manufacturing partners to their clients
News
Expanded Integrated Capabilities
Combines BioCina’s expertise in microbial, pDNA, mRNA, and LNP drug substance manufacturing with NovaCina’s advanced sterile fill-finish solutions for biologics and small molecules, delivering seamless end-to-end development and manufacturing
Regulatory Excellence
State-of-the-art facilities in Adelaide and Perth, fully licensed and inspected by US FDA, EMA, TGA, Health Canada, and other leading global authorities, ensuring world-class compliance and quality