mRNA Development
and Manufacturing
GMP mRNA drug substance manufacturing from sequence to commercial-scale supply, built on a dedicated nucleic acid platform with integrated in-house pDNA template supply, LNP encapsulation, and a direct pathway to sterile fill-finish.
mRNA Manufacturing Platform
Our dedicated Grade C (ISO 7) cGMP environment, physically separated from protein manufacturing suites and purpose-built for mRNA and pDNA manufacturing at clinical and commercial scale.
mRNA Sequence Design and Optimization
We work with client-supplied sequences or support construct optimization for translational performance, stability, and regulatory suitability.
pDNA Template Supply
Linearized pDNA template manufactured in-house within the same Nucleic Acid Suite, removing inter-site transfer and comparability requirements from the earliest stage of the manufacturing chain.
In Vitro Transcription (IVT) and Capping
IVT process optimized for high mRNA yield and transcriptional fidelity. Our platform is capping technology agnostic, with cap structure selection based on your program requirements and IP strategy.
Downstream Purification
Multi-step purification incorporating DNase treatment, dsRNA removal, tangential flow filtration for concentration and buffer exchange, and sterile final filtration, validated for dsRNA impurity levels, residual DNA template clearance, and potency specifications.
mRNA Development
and Manufacturing
In vitro transcription optimized for mRNA yield, capping efficiency, and sequence fidelity.
RNA Modalities We Support
Self-Amplifying RNA (saRNA)
Enhanced expression formats delivering therapeutic effect at lower administered doses, expanding the potential of RNA-based medicines.
Non-Replicating mRNA
The established clinical format for vaccines, protein replacement therapies, and broader therapeutic applications, with a manufacturing platform designed for clinical and commercial scale.
Circular RNA (circRNA)
Stability-enhanced RNA format offering extended expression duration, supporting programs requiring prolonged protein production from a single administration.
Emerging RNA Formats
Support for emerging RNA therapeutic platforms, with our platform designed to adapt to novel formats as the field evolves.
End-to-End Support for Your mRNA Program
Explore the development and manufacturing services that underpin every mRNA program at BioCina.
Process Development
01
Processes Designed to Grow With Your Program.
From bench to commercial scale, we develop bioprocesses built for reproducibility, regulatory confidence, and the long-term success of your therapy.
Analytical Development
02
Analytical Methods Built Around Your Program.
We develop, optimize and validate the analytical methods your program needs, from early characterization through to regulatory submission, with rigor at every step.
Tox Batches
03
Building Confidence Before You Scale.
We execute early-stage manufacturing runs generating the safety and process data your program needs to advance with clarity and confidence.
Process Validation
04
Validation Built for Regulatory Confidence.
We execute rigorous process validation to the standards of the world's most demanding health authorities, giving your regulatory filing the strongest possible foundation.
Tech Transfer
05
A Seamless Transition From Your Facilities to Ours.
We manage every aspect of technology transfer with complete documentation, thorough risk assessment, and your team integrated at every critical milestone.
cGMP Manufacturing
06
Where Programs Become Medicines.
We deliver GMP-compliant manufacturing across drug substance and drug product with the precision, consistency, and regulatory credibility every program deserves.
Did you know manufacturing in Australia could fund nearly half your program?
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Drug Substance Manufacturing Track Record
0+ years
of cGMP manufacturing experience
0
Critical Observations
3
BLA Submissions
0+
products manufactured
Ready to Start Your mRNA Program?
Every mRNA program starts with a conversation. Our team is ready to understand your requirements and find the right path forward.