WHITE PAPER - Small Molecules: Choosing the Right Development Path
Summary
The white paper, Small Molecules: Choosing the Right Development Path, outlines a structured, risk-minimized approach to early CMC (Chemistry, Manufacturing, and Controls) development for small-molecule drugs—particularly for startups and virtual pharma companies with limited resources.
Key messages:
- Start with early developability profiling to assess solubility, stability, permeability, and solid-state properties, preventing costly late-stage failures.
- Use a stage-gate decision framework with clear go/no-go criteria to guide development efficiently and avoid over- or under-engineering.
- Apply enabling formulation technologies when needed—such as hot-melt extrusion, spray drying, or lipid-based systems—to improve bioavailability of poorly soluble compounds.
- Design processes with scalability and GMP readiness from the outset, ensuring smooth transition from preclinical work to clinical manufacturing.
- Implement proactive risk mitigation and regulatory planning, including stability studies, supply chain safeguards, and robust documentation.
- Partnering with an integrated CDMO (e.g., Aenova) can streamline development by providing end-to-end capabilities, minimizing tech transfer risks, and accelerating timelines.
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