From optimized hit to IND-ready dossier
We compress the delivery optimization bottleneck from 18 months to 5 — not by cutting corners, but by front-loading computational work before bench synthesis begins.
Five months, four phases
In Silico Screen
Formulation Engine screens 10,000 ionizable lipid and excipient combinations. Outputs: pKa, EE, particle size, and membrane fusion score for each candidate. Duration: ~3 weeks.
Hit Ranking & Bench Synthesis
HRS composite score selects top-10. We recommend the top-3 for immediate bench synthesis and provide detailed microfluidic synthesis protocols. Duration: 4 weeks.
In Vitro Validation
Cell uptake assay, luciferase reporter transfection, and hepatocyte viability panel in primary human hepatocytes. Lead candidate confirmed with ≥2 biological replicates. Duration: 4–5 weeks.
Scale-Up & IND Package
Process transfer to GMP-compatible microfluidic scale. CMC section drafts for IND module 3 are prepared alongside in vitro pharmacology data. Duration: 5–6 weeks.
What we deliver at the end of Month 5
CMC Drafts (Module 3)
Formulation characterization, manufacturing process description, batch analytical data, and stability summary in FDA IND-compatible format.
In Vitro Pharmacology Report
Hepatocyte transfection efficiency data, viability, and uptake kinetics formatted for IND pharmacology section (Module 2.4).
Synthesis Protocol Package
Microfluidic synthesis protocol, QC release criteria (DLS, TEM, encapsulation), and GMP readiness assessment for your CDMO partner.
18 months → 5 months
The traditional delivery optimization process loses time in two places: combinatorial bench screening (months 1–10) and iterative reformulation after validation failures (months 11–18). We eliminate both bottlenecks by front-loading physics-informed screening.
Traditional
Gendelivr
Ready to compress your IND timeline?
Start with your target: tissue type, payload, and route. We'll run the in silico screen and have your first hit list in 3 weeks.