Our Drug Substance Capabilities
Microbial Fermentation
Australia's most established commercial-scale microbial fermentation platform, with over 40 years of continuous operation and fermentation scale from process development through to 500 L cGMP commercial supply.
Explore Microbial Fermentation
Plasmid DNA
cGMP plasmid DNA manufacturing from preclinical milligram quantities through to commercial gram-scale batches, serving mRNA template supply, gene therapy vector production, DNA vaccines, and CRISPR delivery programs.
Explore Plasmid DNA
mRNA
End-to-end GMP mRNA drug substance manufacturing from in vitro transcription through to purification and formulation, with an integrated upstream pathway connecting in-house plasmid DNA manufacturing and downstream LNP encapsulation.
Explore mRNA Manufacturing
Lipid Nanoparticle (LNP)
GMP lipid nanoparticle encapsulation for a broad range of payloads using precision microfluidic technology, from early formulation development through to commercial-scale manufacture, with full flexibility for client-proprietary lipid systems.
Explore LNP
Program Lifecycle From Concept to Commercial
01
Concept and Design
Sequence evaluation, expression system selection, and manufacturing strategy aligned to your regulatory and commercial objectives.
02
Cell Line Development and Process Design
Host strain selection, cell banking, and early process development establishing the biological foundation of your program.
03
Process Development and Optimization
Scale-up from bench to cGMP scale, with process characterization and optimization designed for reproducibility and regulatory confidence.
04
Scale-Up Readiness
Tox batches, process validation, and technology transfer preparing your program for cGMP manufacturing.
05
Commercial Manufacturing and Supply
cGMP manufacturing campaigns, quality release, and ongoing commercial.
Why BioCina for Your Drug Substance Program
Our team has spent decades taking biologics programs from early clinical supply through to globally shipped commercial product. We understand the science, the scale, the regulatory complexity, and logistics that your drug substance programs demand.
Any Sequence at Any Stage
From a target sequence to a fully developed process, our capabilities adapt to meet your program exactly where it is.
From Drug Substance to Drug Product
An integrated pathway from bulk drug substance through to sterile fill-finish, delivering continuity and confidence from first batch to finished medicine.
Deep Biologics Expertise
From early clinical supply to full commercial manufacturing, every stage of your program supported end-to-end under one partner.
Built Around Your Program
Proven, standardized workflows with the flexibility to adapt or develop new approaches when your program demands it. Every manufacturing strategy is aligned tothe specific scientific, regulatory, and commercial requirements of your therapy.
Drug Substance Manufacturing Track Record
0+ years
of cGMP manufacturing experience
0
Critical Observations
3
BLA Submissions
0+
products manufactured
Ready to Scale Your Drug Substance Program?
Let’s talk about your biologics development and manufacturing needs.