BioCina
BioCina is an Australian end-to-end CDMO providing integrated biologics drug-substance (microbial fermentation, pDNA, mRNA, LNP) and sterile fill-finish drug-product manufacturing for global pharmaceutical and biotech companies across clinical and commercial stages.
- Company typePrivate
- Founded2021
- HeadquartersThebarton, Australia
- Headcount101–250
- GTM typeB2B
- OfferingServices
What BioCina does
BioCina is an Australian end-to-end Contract Development and Manufacturing Organization (CDMO) that delivers integrated biologics drug-substance and sterile fill-finish drug-product manufacturing for pharmaceutical and biotech companies globally. The drug-substance platform spans microbial fermentation (E. coli, Pichia pastoris, Saccharomyces cerevisiae at up to 500L cGMP scale), plasmid DNA, messenger RNA (up to 100g per batch), and lipid nanoparticle encapsulation via microfluidic NanoAssemblr technology, with a dedicated Grade C (ISO 7) nucleic acid suite physically separated from protein manufacturing. The drug-product platform comprises seven blow-fill-seal lines delivering 200M+ units annually, sterile vial filling across three validated environments (DARA terminal sterilization, RABS aseptic filling, SA25 Cytiva robotic isolator), pre-filled syringes and cartridges, oral liquids, packaging with serialization, a dedicated cytotoxic facility with OEB5 containment, and controlled-substance manufacturing under AU Schedule 8 / US Schedule 2 licensure. Supporting services include cell line development, QbD-led process development, formulation development, ICH-aligned analytical services, toxicology batches, tech transfer, and dedicated project management.
BioCina operates from two Australian sites — the Adelaide biologics drug-substance facility and the Perth drug-product facility — under Bridgewest Group ownership, following the 2025 merger of BioCina and NovaCina. The combined entity inherits 50+ years of continuous GMP manufacturing heritage from the legacy Hospira and Pfizer operations, including a US FDA pre-approval inspection completed with zero observations, and supplies 600+ approved products across more than 140 countries under regulatory licensure from FDA, EMA, TGA, Health Canada, ANVISA, and PMDA. Customer segments include biopharmaceutical companies requiring clinical-through-commercial CDMO services, biosimilar and generic injectable developers, RNA therapeutics developers, and oncology programs requiring high-potency containment. Revenue is generated through project-based, milestone-driven multi-year contracts priced individually based on program scope, manufacturing scale, regulatory pathway, and capacity commitment, with a GTM motion that is enterprise field sales-led and supported by dedicated project managers assigned to each program from contract through final batch release.
BioCina firmographics
Firmographics- Name
- BioCina
- Legal name
- Bridgewest Australia Biotech Pty Ltd
- Website
- https://biocina.com
- Company type
- Private
- Founded year
- 2021
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Short description
- BioCina is an Australian end-to-end CDMO providing integrated biologics drug-substance (microbial fermentation, pDNA, mRNA, LNP) and sterile fill-finish drug-product manufacturing for global pharmaceutical and biotech companies across clinical and commercial stages.
- Ownership category
- akta.pro rank
BioCina industry classification
Industry- Product category
- Contract Development and Manufacturing Services (CDMO)
- NAICS
- Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (32541)
- SIC
- Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836), Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Sterile Fill-Finish & Aseptic Manufacturing CDMO (HLAGABAH)
- akta.pro secondary industries
- Biologics (mAbs/Recombinant Proteins) CDMO (HLAGABAC), mRNA & Nucleic Acid Manufacturing Services (mRNA/saRNA/Plasmid DNA) (HLAGAGAC), Drug Product Fill-Finish & Aseptic Manufacturing Services (HLAAAKAB), GMP Quality, Validation & Regulatory Support (GMP/CSV/Qualification) (HLAGAGAL)
Keywords
Where BioCina is headquartered
LocationHeadquarters
- HQ city
- Thebarton
- HQ country
- Australia
- HQ region
- Oceania
Offices2 records
Markets served
BioCina business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Infrastructure, Technology or R&D, Marketing or Sales, Supply Chain
Revenue model
- Contract Development and Manufacturing Services: BioCina generates revenue through contract development and manufacturing services for pharmaceutical and biotech companies. Services span drug substance manufacturing (microbial fermentation, pDNA, mRNA, LNP) and drug product manufacturing (sterile fill-finish across BFS, vials, prefilled syringes, oral liquids, cytotoxics, controlled substances). Revenue is generated through project-based contracts with clinical and commercial programs, typically structured as milestone-based engagements with dedicated capacity commitments.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Project-based contract manufacturing pricing |
Go-to-market motion1 record
Distribution channels1 record
Marketing channels4 records
BioCina product offering
Product offeringCore offering
BioCina is an end-to-end Contract Development and Manufacturing Organization (CDMO) providing integrated biologics drug substance and sterile fill-finish manufacturing services. The company offers microbial fermentation (E. coli, Pichia pastoris, Saccharomyces cerevisiae up to 500L cGMP), plasmid DNA and mRNA manufacturing, lipid nanoparticle encapsulation, and a full suite of sterile fill-finish capabilities including blow-fill-seal, vial filling, pre-filled syringes, oral liquids, cytotoxics, controlled substances, and packaging. Services span process development, formulation, analytical, and cGMP clinical through commercial manufacturing for biotech and pharmaceutical clients globally.
Product overview
BioCina is an end-to-end Contract Development and Manufacturing Organization (CDMO) offering integrated biologics drug substance and sterile fill-finish manufacturing for biologics and small molecules. The company operates as a single unified platform with two main divisions: Drug Substance (microbial fermentation, plasmid DNA, mRNA, and lipid nanoparticles) and Drug Product (blow-fill-seal, sterile vial filling, pre-filled syringes, oral liquids, packaging, cytotoxics, controlled substances, and diluent). Supporting services include cell line development, process development, formulation development, analytical services, tox batches, cGMP manufacturing, tech transfer, and project management. BioCina's integrated approach enables programs to move from clinical batches through commercial supply under one manufacturing partner.
Differentiator
Problem solved
Functional benefit
Products and services
- Blow-Fill-Seal (BFS) Aseptic Manufacturing Aseptic sterile fill-finish technology forming, filling, and sealing containers in a single continuous automated process; over 35 years of expertise across seven lines delivering 200M+ units annually for sterile injectables and other products.
- Sterile Vial Filling Precision aseptic filling in glass vials for injectable drug products at clinical and commercial scale, using DARA Terminal Sterilization, RABS Aseptic Filling, and SA25 Cytiva Robotic Isolator validated filling environments.
- Pre-Filled Syringes and Cartridges Fully closed robotic aseptic filling for pre-filled syringes, cartridges, and injectable device programs using the SA25 Cytiva Robotic Isolator, with flexible batch sizes from first-in-human through commercial scale.
- Oral Liquids Manufacturing Clinical and commercial-scale oral liquid manufacturing spanning syrups, solutions, and suspensions for pediatric, geriatric, oncology supportive care, and specialty pharma programs.
- Packaging Services End-to-end packaging solutions including primary labelling, cartoning, serialization, track-and-trace, and secondary packaging within a single GMP environment.
- Cytotoxic Manufacturing Dedicated cytotoxic and high-potency drug product manufacturing with 30+ years of experience, featuring a purpose-built oncology facility with OEB5 containment and RABS filling.
- Controlled Substances Manufacturing Licensed manufacturing of controlled substances (AU Schedule 8, US Schedule 2) with vault storage, diversion controls, and chain-of-custody protocols for oral liquids and injectable drug products.
- Diluent Manufacturing High-volume sterile diluent manufacturing in single-dose BFS format including Water for Injection and Sodium Chloride 0.9% formulations with multi-jurisdictional regulatory approvals.
- Biosimilars and Generics Manufacturing Integrated drug substance and drug product manufacturing for biosimilar and generic injectable programs under one manufacturing partner, with FDA, EMA, and TGA approvals.
- Microbial Fermentation Manufacturing Australia's most established commercial-scale microbial fermentation platform with 40+ years of continuous operation, supporting E. coli, Pichia pastoris, and Saccharomyces cerevisiae expression from development through 500L cGMP commercial supply.
- Plasmid DNA (pDNA) Manufacturing cGMP plasmid DNA manufacturing from preclinical milligram quantities through commercial gram-scale batches, serving mRNA template supply, gene therapy vector production, DNA vaccines, and CRISPR delivery programs.
- Messenger RNA (mRNA) Manufacturing End-to-end GMP mRNA drug substance manufacturing from in vitro transcription through purification and formulation, with integrated upstream pDNA-to-mRNA pathway and downstream LNP encapsulation, capacity up to 100g mRNA per batch.
- Lipid Nanoparticle (LNP) Encapsulation GMP lipid nanoparticle encapsulation using precision non-turbulent microfluidic technology (NanoAssemblr platform) from early formulation development through commercial-scale manufacture, accommodating open-platform, proprietary, and novel multi-component lipid systems.
- Cell Line Development Sequence optimization, expression vector selection, strain screening, and cGMP cell banking from research cell bank generation through fully characterized master and working cell banks.
- Process Development and Validation QbD-led upstream and downstream development for microbial fermentation, nucleic acid, and drug product programs with DOE-driven optimization designed for scale from the outset.
- Formulation Development End-to-end formulation support including buffer selection, injectable drug product formulations, stability studies, and reverse engineering for ANDA and 505(b)(2) pathways.
- Analytical Services ICH-aligned method development, validation, and lifecycle management including release testing, comparability packages, stability studies, and full analytical packages for regulatory submissions.
- Tox Batches Early-stage manufacturing runs generating safety and process data including GMP engineering runs, toxicology batch supply, and CMC documentation supporting IND, CTN, and commercial submissions.
- cGMP Manufacturing and Regulatory Support Clinical and commercial GMP manufacturing across microbial drug substance, nucleic acids, and sterile drug product with in-house GMP release testing and CMC section authoring, capacity exceeding 225M units annually.
- Tech Transfer Structured technology transfer with formal gap analysis, analytical method transfer, process comparability packages, and CMC filing support for regulatory submissions.
- Project Management Dedicated project management with full program visibility across Drug Substance and Drug Product, coordinating every function, milestone, and deliverable from contract to final batch release.
Quantifiable outcome
- 50+ years of continuous GMP manufacturing heritage
- +5 more outcomes
Companies that use BioCina
Customer profileNamed customers5 records
Segments4 records
Ideal customer profiles4 records
BioCina technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature8 records
BioCina partnerships and signals
Strategic signalPartnerships
Four partnerships are on record, tiered core and flagship.
- PatryscoreBioCina initiated a comprehensive CMC manufacturing program for Patrys' proprietary injectable therapeutic (RLS-2201) aimed at alleviating delirium. Manufacturing program encompasses full drug substance and drug product development.
- NovaCinaflagshipStrategic merger creating combined company operating as BioCina. The merger enhances biopharmaceutical and small molecule contract manufacturing services, strengthening market position by integrating facilities and expertise in Australia to serve clients globally.
- CytivacoreCollaboration on RNA vaccine and therapeutics development. BioCina received a $3.0M AUD grant from the Australian government for RNA vaccine development, collaborating with Cytiva and the University of Adelaide. The project aims to accelerate RNA product development and clinical trials, focusing on advanced formulations such as lipid nanoparticles and circular RNA.
- University of AdelaidecoreAcademic partnership in RNA vaccine and therapeutics development collaboration. Part of $3.0M AUD government grant project focusing on RNA product development, lipid nanoparticles, and circular RNA formulations.
Scale indicators10 records
Recent moves7 records
Expansion highlights6 records
BioCina competitors and assessment
Company assessmentDirect peers
- Lonza Group: Global leader in biologics CDMO with extensive microbial fermentation, mammalian cell culture, and fill-finish capabilities across scales exceeding BioCina's 500L. Direct competitor for recombinant protein and nucleic acid manufacturing programs at clinical and commercial stages.
- Vetter Pharma: Specialty CDMO focused on aseptic fill-finish of prefilled syringes, vials, and cartridges. Directly competes with BioCina's PFS and sterile vial filling offerings for injectable biologics.
- AGC Biologics: Mid-sized global CDMO with microbial and mammalian cell culture capabilities plus aseptic fill-finish. Closely comparable in scale to BioCina, often competing for similar clinical-to-commercial biologics programs.
- Recipharm: European CDMO with strong sterile fill-finish and blow-fill-seal capabilities. Overlaps with BioCina's BFS platform and injectable manufacturing service offering.
- Catalent: Major global CDMO with strong sterile fill-finish, blow-fill-seal, and biologics drug substance capabilities. Directly competes for sterile injectable and biologic manufacturing programs, including softgel and oral dose forms.
- IDT Biologika: German CDMO specializing in microbial fermentation, vaccines, and biologics fill-finish with similar mid-market positioning to BioCina. Directly comparable in microbial platform depth and sterile injectable manufacturing.
Broad incumbents
- WuXi Biologics: Largest China-based biologics CDMO with extensive microbial and mammalian manufacturing capacity. Competes globally for recombinant protein, mAb, and biosimilar manufacturing contracts.
- Samsung Biologics: One of the world's largest biologics CDMOs with mega-scale mammalian bioreactors. Competes with BioCina for large commercial biologics contracts and offers integrated fill-finish at much greater scale.
- Thermo Fisher Scientific (Patheon): Diversified CDMO through its Patheon business offering biologics, small molecule, and fill-finish services. Competes broadly across BioCina's portfolio from clinical through commercial scale.
Emerging players
- Charles River Laboratories: Bioproduction services and CDMO offerings include microbial fermentation and biologics manufacturing, providing comparable clinical-stage services to BioCina's drug substance capabilities.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat6 records
Key risks6 records
Key highlights7 records
Customer concentration
BioCina social profiles
Digital presenceBioCina compliance and trust
Trust signalCompliance5 records
BioCina financial estimates
Financial estimateRevenue estimate
Valuation estimate
BioCina leadership team
Management profileNumber of profiles
Profiles9 records
BioCina funding detail
Funding detailFunding overview
Funding rounds2 records
Investors1 record
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
BioCina M&A and investment
M&A and investmentM&A1 record
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about BioCina
What does BioCina do?
BioCina is an end-to-end Contract Development and Manufacturing Organization (CDMO) providing integrated biologics drug substance and sterile fill-finish manufacturing services. The company offers microbial fermentation (E. coli, Pichia pastoris, Saccharomyces cerevisiae up to 500L cGMP), plasmid DNA and mRNA manufacturing, lipid nanoparticle encapsulation, and a full suite of sterile fill-finish capabilities including blow-fill-seal, vial filling, pre-filled syringes, oral liquids, cytotoxics, controlled substances, and packaging. Services span process development, formulation, analytical, and cGMP clinical through commercial manufacturing for biotech and pharmaceutical clients globally.
Is BioCina a public or private company?
BioCina is a private company. It is classified as corporate owned and is currently operating.
When was BioCina founded?
BioCina was founded in 2021. It employs 101 to 250 people.
Where is BioCina based?
BioCina is headquartered in Thebarton, Australia, in the Oceania region.
How does BioCina make money?
One revenue line is on record: contract Development and Manufacturing Services.
Who are BioCina's main competitors?
Direct peers on record are Lonza Group, Vetter Pharma, AGC Biologics, Recipharm, Catalent and IDT Biologika. Broad incumbents are WuXi Biologics, Samsung Biologics and Thermo Fisher Scientific (Patheon). Charles River Laboratories is listed as an emerging player.
Does BioCina have an API?
No public API is recorded for BioCina.
What industry is BioCina in?
BioCina's product category is Contract Development and Manufacturing Services (CDMO). Its primary akta.pro industry code is HLAGABAH, Sterile Fill-Finish & Aseptic Manufacturing CDMO, with a secondary code of HLAGABAC, Biologics (mAbs/Recombinant Proteins) CDMO. Its NAICS code is 325414 and its SIC code is 2834.