Spin freeze-drying in continuous biomanufacturing: Boon or mirage?

Spin freeze-drying (SFD) has emerged as a potential breakthrough in pharmaceutical lyophilization. It promises over 90 % reductions in cycle time and is compatible with continuous aseptic manufacturing. SFD generates thin frozen films through centrifugal spreading and improves sublimation and desorption with radiative heating. This approach fundamentally changes heat and mass transfer compared to traditional shelf-based drying. Mechanistic studies connect thin-film structure to sublimation flux, desorption speed, and interactions between excipients and proteins. Case studies involving monoclonal antibodies, viral vectors, and mRNA–lipid nanoparticles show opportunities for better stability and quicker processing.

On the manufacturing side, SFD introduces new ideas for batch definition, container and closure interactions, and aseptic assurance. It requires integrating process analytical technologies (PAT), mechanistic modeling, and digital twin control. Regulatory translation must consider Quality by Design (QbD) principles and ICH Q13 guidelines for continuous manufacturing. While the potential benefits of SFD for biopharma are clear, like shorter cycles and smaller footprints, risks still exist. These include unproven industrial scalability, regulatory uncertainty, and challenges in optimizing specific formulations. The future of SFD will depend on whether mechanistic control, PAT-enabled validation, and regulatory acceptance can come together to support routine GMP use. If successful, SFD could become a key part of next-generation continuous biomanufacturing; if not, its use may stay limited to specific areas.

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Teja Kumar Ponduri, G.S.N. Koteswara Rao,
Spin freeze-drying in continuous biomanufacturing: Boon or mirage?,
Journal of Drug Delivery Science and Technology, Volume 116, 2026,
107909, ISSN 1773-2247,
https://doi.org/10.1016/j.jddst.2025.107909.