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Phase 2: Research & Lab-Scale Development (CMC)
In-Silico Modeling, Micro-Factory Synthesis (32nm) & CMC Assay Development
Translates the strategic blueprint into physical laboratory reality under strict GMP-lite controls. Incorporates advanced in-silico modeling, multivariate Design of Experiments (DoE), automated micro-factory synthesis (yielding 32 nm particles with PDI < 0.2), analytical active assay development, and container closure verification.
• Laboratory Prototype Batches & Micro-Factory Synthesis Runs
• In-Silico Modeling & Multivariate Design of Experiments (DoE) Dossier
• Analytical Method Development & Validation Report
• Initial Stability Data & Container Closure Verification File
Custom Scoping (Indexed to Baseline: R 20,600+)
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