Bridging the Gap—Scaling Up Nanofiber Production for Biomedical Applications

The transition from academic needle-based electrospinning to commercial roll-to-roll production presents formidable challenges in modifying processes to match structure and performance of the intended the nanofiber material. Moving from single needled systems to multi-needle/multi-nozzle or needless production means significant changes to the electric field geometry, the solvent vapor pressure in the spinning environment, and the fiber density at the substrate. These factors play a critical role during the spinning process, significantly affecting material properties, microstructure, defect formation, and reproducibility. This research addresses pivotal pitfalls encountered during scale-up that hamstring the real-world impact of innovations in the nanofiber research community. To advance the field, we propose a comprehensive checklist of essential parameters that should be reported in academic literature to enhance reproducibility and facilitate smoother transitions to commercial applications. Examples of production of PAN, PCL, PVDF, TPU, and gelatin are used as case studies. We will also present characterization tools and quantitative techniques for quality assurance and defect characterization, a critical consideration for GMP production. Key findings reveal prevalent issues in lab-scale production, such as reliance on fluorinated solvent choices or incomplete tracking of environmental conditions that may impede scalability. These problems are exacerbated for many specialty nanofibers with additions of active pharmaceutical ingredient incorporation, cell interactions, and nanoparticle functionalization. These practical experiences provide a holistic perspective on mitigating defects and enhancing process monitoring in nanofiber production. Ultimately, our work aims to equip researchers and industry professionals with the knowledge necessary to streamline the scale-up process, fostering the translation of nanofiber technologies into transformative biomedical applications.