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<p>From R&amp;D To Production: Scale-Out of Continuous Spin-Freeze-Drying for a Pegylated Peptide Formulation</p>

Authors: Zarah Schaal; Laurens Leys; Pieter-Jan Van Bockstal; Adrian P. Funke; Stefan C. Schneid; Thomas De Beer;

<p>From R&amp;D To Production: Scale-Out of Continuous Spin-Freeze-Drying for a Pegylated Peptide Formulation</p>

Abstract

Scale-out is a critical barrier for translating continuous spin-freeze-drying from development to GMP-relevant manufacturing. In this study, a continuous spin-freeze-drying process for a model PEGylated peptide formulation was transferred from a single-vial-lab-scale R&amp;D unit (RheaLyo™ Mono) to a GMP-compatible prototype line (GMP-Flex). Identical spin-freezing and drying settings were applied on both platforms to directly assess the reproducibility of process performance during scale-out. Product temperature profiles during freezing and drying aligned closely between RheaLyo™ Mono and GMP-Flex, indicating comparable thermal histories across scales. Product quality was assessed by cake appearance, residual moisture content, peptide concentration by RV-HPLC and monomer levels by SEC. All samples formed intact cakes without signs of collapse and maintained monomer levels close to 100 percent, indicating no detectable aggregation upon transfer. Residual moisture contents for both platforms were within the same overall range and met the predefined target of 0.3-0.6%. Residual moisture levels on the GMP-Flex™ system showed no timing-dependent trend over the production run, confirming stable, steady-state drying performance throughout continuous production. Overall, these results demonstrate for the first time the successful scale-out of continuous spin-freeze-drying under the matched process conditions while maintaining consistent product quality.

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
Average
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