Company Category: Specialized Modalities (Biologics, Cell & Gene, mRNA, ADCs)

We are a global end-to-end biologics Contract Development and Manufacturing Organisation (CDMO), offering highest-quality, cost-effective cell line, process, analytical and formulation development, and cGMP clinical & commercial manufacturing of the microbial, pDNA and mRNA modalities. Our US FDA, EMA and TGA approved site in South Australia, which was previously part of Pfizer, 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. Because we are not a drug developer, we only serve our client’s products and through our partnership with NovaCina, we are also able to offer our clients a highest-quality fill-and-finish solution. | BioCina is a global end-to-end Contract Development and Manufacturing Organisation (CDMO) offering clients unparalleled quality, adherence to the highest regulatory standards, and industry-leading on-time and in-full delivery, setting a new benchmark in the industry for quality and reliability. With deep expertise in small molecules, microbial, pDNA and mRNA modalities, BioCina’s comprehensive service offerings include cell line development, process development, analytical and formulation development, and cGMP clinical and commercial manufacturing. BioCina operates two state-of-the-art facilities in Adelaide, South Australia and Perth, Western Australia. The facilities boast a rich history of developing and manufacturing clinical and commercial drug substances and drug products, backed by highly experienced Subject Matter Experts (SMEs) with an average tenure of more than 10 years. BioCina maintains an elite quality record, meeting the highest international standards. The facilities have successfully passed regulatory inspections by the US FDA, EMA, and Health Canada, and are licensed by the Australian TGA for cGMP manufacturing of bulk drug substance and sterile drug product. BioCina has a proven track record of producing high-quality drug products distributed to 98 countries across North America, South America, Europe, Asia, and Africa. BioCina is proud to serve clients from every major market in the global industry, and because BioCina is not a drug developer, its focus is solely on serving its clients’ products. Australia offers one of the most attractive tax incentives available globally (up to 48.5% cash refund), making it an ideal destination for drug developers looking to invest in scaling-up and manufacturing their products. As one of the fastest growing companies in the biopharmaceutical industry across Australia, BioCina was awarded the 2024 South Australia “Emerging Business of the Year” award. Learn more at https://biocina.com. | 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 GMP facilities spanning drug substance biologics and sterile fill-finish drug product, BioCina is the leading end-to-end CDMO in Australia and the Southern Hemisphere — offering clients a single project team and seamless progression from molecule to market. A Heritage Built for Complex Manufacturing BioCina’s GMP facilities carry a combined pharmaceutical heritage of over 50 years, previously part of Pfizer’s global manufacturing network by way of Hospira. Our specialists carry an average tenure of 15 years, delivering industry-leading OTIF performance across clinical and commercial supply, across modalities, and across 100+ countries. Over 600 approved products bear that manufacturing history. Drug Product: The Full Spectrum of Sterile Fill-Finish BioCina operates 10 state-of-the-art filling lines with annual capacity exceeding 225 million units, serving both small molecule and biologics programs across the full range of sterile formats: Blow-Fill-Seal (BFS): Seven dedicated lines producing preservative-free, aseptically filled sterile liquids for ophthalmic, inhalation, irrigation, and injectable applications. Multiformat Injectables (Terminal Sterilisation): High-volume vials and glass bottles for IV medications, hospital generics, and small molecule injectables. Cytotoxic Fill-Finish: A dedicated line under Restricted Access Barrier System (RABS) containment for oncology and high-potency liquid injectables. SA25 Cytiva Robotic Aseptic Isolator: Fully closed, robotic filling for vials, prefilled syringes, and cartridges — highest sterility assurance for biologics, biosimilars, and oxygen-sensitive products. EU Annex 1 compliant. Controlled Substances: Manufacturing licences for scheduled drugs enabling GMP production of opioids, benzodiazepines, stimulants, methadone, and more. Non-Sterile Oral Liquids: Commercial-scale production in PET and HDPE bottles, including paediatric, oncology supportive care, and controlled substance formulations. Drug Substance: From Cell to Bulk BioCina offers fully integrated biologics drug substance development and manufacturing, from upstream through to purified and characterised bulk material. Microbial fermentation is the foundation — over 35 years of expertise, scales from development through to commercial production, with full downstream processing and in-house analytical development, method validation, and stability programs. BioCina also offers fully integrated pDNA, mRNA, and LNP manufacturing at clinical and commercial scale — covering plasmid DNA production, in vitro transcription, mRNA capping and purification, and precision microfluidic LNP encapsulation across mRNA, pDNA, saRNA, proteins, peptides, and small molecule payloads — with direct handoff to fill-finish under one organisation. Regulatory Credentials That Travel With Your Product BioCina’s facilities are registered with and inspection-ready, holding product approvals from the US FDA, EMA, TGA, PMDA (Japan), Health Canada and many other leading regulatory authorities, spanning 100+ countries. Australia as a Strategic Advantage Manufacturing in Australia is a competitive position. The Clinical Trial Notification (CTN) pathway enables first-in-human studies to begin in as little as 30 days from submission. The Australian Government’s R&D Tax Incentive provides eligible companies with a refundable tax offset of up to 43.5% on qualifying development expenditure — meaningfully extending program runway. Australia’s political stability, strong IP framework, and English-language operating environment reduce risk. BioCina’s APAC position also provides practical advantages for clients targeting Korean, Japanese, and Southeast Asian markets.