Lipid Nanoparticle Encapsulation
GMP lipid nanoparticle encapsulation for a broad range of payloads, using precision non-turbulent microfluidic technology from early formulation development through commercial-scale manufacture. Fully formulation-agnostic, accommodating open-platform, proprietary, and novel multi-component lipid systems.
LNP Manufacturing Platform
From pDNA template through mRNA synthesis to LNP encapsulation, all within the same facility. Programs requiring sterile fill-finish continue directly to BioCina's drug product facility, keeping the full journey within one manufacturing partner.
Lipid Screening and Ionisable Lipid Optimization
We test and refine ionisable lipid selection, helper lipid composition, PEG-lipid ratio, and particle size targeting against your specific payload requirements, identifying your lead formulation candidate at rapid µL-to-mL scale.
Self-Assembly and Microfluidic Mixing at Scale
Using the NanoAssemblr platform from Precision NanoSystems, including the NanoAssemblr Blaze for scale-up bridging, non-turbulent microfluidic mixing ensures precise, reproducible particle formation from process development through to cGMP manufacture.
Analytical QC and Stability Testing
Comprehensive LNP-specific analytical characterization covering particle size by DLS, zeta potential, encapsulation efficiency, residual ethanol, total nucleic acid concentration, endotoxin, bioburden, pH, and osmolality, with reproducibility and purity data supporting regulatory submissions.
Formulation to Scale
Lead formulation scaled from process development through to engineering batches and commercial-scale cGMP manufacture, with process characterization establishing the design space for reproducible GMP production and integrated progression to sterile fill-finish.
LNP Manufacturing
Precision non-turbulent microfluidic mixing optimized for reproducible particle size, polydispersity index, and encapsulation efficiency across all scales.
Modality-Agonistic Encapsulation.
Recombinant Proteins and Peptides
LNP-mediated intracellular delivery for programs where lipid-based delivery offers a clinically meaningful advantage over conventional formulation approaches.
Nucleic Acid Payloads
mRNA, saRNA, circRNA, pDNA, siRNA, and antisense oligonucleotides for vaccines, cancer immunotherapy, gene therapy, gene editing, and RNA interference programs.
Small Molecules
Lipid nanoparticle formulation for oncology and targeted delivery programs requiring improved bioavailability or targeted tissue distribution.
Multi-Component Systems
Co-encapsulation of nucleic acid and protein components for multi-modality therapeutic programs requiring combined delivery.
End-to-End Support for Your LNP Program
Explore the development and manufacturing services that underpin every LNP program at BioCina.
Formulation Development
01
Formulation Strategies Tailored to Your Therapy.
We develop and optimize formulations to meet the stability, bioavailability, and manufacturability requirements your drug product needs.
Process Development
02
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
03
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
04
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
05
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
06
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
07
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 LNP Program?
Every LNP program starts with a conversation. Our team is ready to understand your requirements and find the right path forward.