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Derisk Therapeutic Nanoparticle Programs with Stage-Appropriate Analytical Method Development
Analytical method development is inseparable from formulation and process development, yet it is often not treated as such. This article makes the case for a risk-based, stage-appropriate approach to analytics that builds understanding of physicochemical properties, stability, and biological performance from feasibility through clinical manufacture. Drawing on more than two decades of Phosphorex’s experience across LNPs, polymeric nanoparticles, and microspheres, the article explores how implementing the right methods at the right time accelerates programs, reduces costly rework, and positions programs for regulatory success.
Download the Article to Learn:
- Why analytical method development must be integrated with formulation and process development from the outset
- Which physicochemical attributes matter most at the proof-of-concept stage
- The analytical considerations unique to polymeric microspheres
- How PK and biodistribution characterization strategies should evolve as programs advance
- What regulators expect from identity, purity, safety, and tolerability methods as programs move toward GMP manufacturing
- How Phosphorex has adapted gold-standard methods to improve throughput, reduce variability, and accelerate formulation screening