A defect-free nanofiber is not yet a medicine: The translational debt of pharmaceutical electrospinning.

Abstract

Pharmaceutical electrospinning increasingly enables sophisticated drug-loaded architectures, yet structural innovation does not necessarily translate into clinically or industrially viable medicines. This Commentary introduces complexity-induced translational debt as a conceptual lens for considering the incremental manufacturing, analytical, stability, pharmacokinetic, usability, and scale-up obligations created by added architectural, compositional, or process complexity. We propose that added complexity be considered in relation to the therapeutic or product-level value it is intended to provide, ideally against an appropriate simpler comparator. Two complementary principles are proposed: minimum sufficient complexity, which favors the least complex design capable of meeting the intended product requirements, and complexity-evidence-control alignment, which considers whether the evidence and control strategy are commensurate with the complexity and claims introduced. Representative studies illustrate how added complexity may be justified, incompletely supported, or outweighed by manufacturability considerations. A product-centered development strategy integrating exposure evidence, pharmaceutical quality attributes, and process control may help shift electrospun systems from elegant laboratory constructs toward reproducible drug products with credible therapeutic, manufacturing, and translational value in practice.

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