Consultancy & Research
Applying formal design standards to biological systems to improve reproducibility, traceability, and regulatory alignment.
Our work →Development and application of SBOL3-compliant representations for complex biological systems. Machine-readable, interoperable design descriptions that support reproducibility and systematic learning.
Structured approaches to nanoparticle therapeutic design across molecular composition, particle architecture, biological interaction, manufacturing process, and clinical outcome.
Mapping structured biological design representations to CMC requirements across MHRA, EMA, and FDA frameworks. Supporting alignment with Pharmaceutical Quality by Design principles.
A framework describing the layers at which design decisions are made in nanoparticle therapeutics. SBOL3 provides a consistent, machine-readable representation across all layers.
| Layer | Domain | Focus | Status |
|---|---|---|---|
| L5 | Clinical Outcome | Efficacy · Safety · Biodistribution | |
| L4 | Manufacturing Process | CMC · Batch consistency · Site transfer | |
| L3 | Biological Interaction | Cellular uptake · Immunogenicity · Targeting | |
| L2 | Particle Architecture | Size · Surface charge · PEGylation · Cargo | |
| L1 | Molecular Composition | Lipid ratios · Nucleic acid payload · Excipients | Active — v1 |
A structured SBOL3 reference implementation for mRNA lipid nanoparticle formulation design. Explicit encoding of composition, molar ratio, and functional roles — with direct mapping to CMC regulatory interpretation. Based on the publicly documented SM-102 four-component formulation. Focused on L1 molecular composition as a constrained reference implementation.
The reproducibility crisis in nanomedicine is not a science problem. It is a description problem.
What molar ratios actually encode is a set of interlocking design decisions, each with regulatory consequence.
SBOL3 handles component identity and relationships cleanly. Then it starts to stretch.
Collaboration and technical discussion welcome.