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 approval for global submissions.
What We Handle
Drug Substance
Microbial fermentation across E. coli, Pichia pastoris, and Saccharomyces cerevisiae. Process development and cGMP manufacture. Cell banking, upstream and downstream processing, chromatography, TFF, refolding, and purification.
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Drug Product
Sterile fill-finish across vials, prefilled syringes, and cartridges via the SA25 Cytiva robotic isolator, EU Annex 1 compliant. Terminal sterilization for applicable generic injectable formats. BFS platform for high-volume generic sterile liquids. Non-sterile oral liquids for controlled and non-controlled generic programs.
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Formulation Development and Reverse Engineering
End-to-end formulation support for lead candidates, including reverse engineering for of reference listed drugs (RLDs) to support ANDA and 505(b)(2) product development pathways. Solubility, stability, and compatibility strategies developed through to cGMP-ready scale-up.
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Analytical Comparability
Full analytical development and comparability support, from method development, verification and validation through to ICH-aligned stability studies and regulatory submission packages.
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Supply Chain Diversification
FDA, EMA, and TGA-approved manufacturing outside the US, EU, China, and India. A politically stable, IP-protected manufacturing base for companies managing concentration risk in their global manufacturing networks.
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Why Integration Matters
Reduced Comparability Risk
Separate DS and DP organisations introduce manufacturing variability that creates analytical signals in regulatory submissions. One partner across fermentation and fill-finish removes that risk.
Simplified Regulatory Package
One manufacturing partner reduces site qualification burden and produces more consistent CMC data across ANDA, biosimilar, and equivalent submissions.
Seamless Development to Supply
Process knowledge stays within one organisation from development through commercial supply, with no documentation gaps or bridging studies between stages.
The Australia Advantage
For biosimilar and generic programs, Australia delivers on four fronts.
Australia's established CRO landscape and Clinical Trial Notification (CTN) pathway provide fast access to first-in-human data, accelerating your development timeline.
Did you know manufacturing in Australia could fund nearly half your program?
Learn More
Drug Product Manufacturing Track Record
0+ years
of Sterile Manufacturing Heritage
0M+ units
Annual Capacity
0+
Approved Products
0+
Countries Delivered
Ready to Advance Your Biosimilar or Generic Program?
Partner with BioCina for integrated, compliant manufacturing of biosimilar and generic drug products.