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Purpose Spray drying plays an important role in the pharmaceutical industry for product development of sensitive bio-pharmaceutical formulations. Process design, implementation and optimisation require in-depth knowledge of process-product interactions. Here, an integrated approach for the rapid, early-stage spray drying process development of trehalose and glucagon on lab-scale is presented. Methods Single droplet drying experiments were used to investigate the particle formation process. Process implementation was supported using in-line process analytical technology within a data acquisition framework recording temperature, humidity, pressure and feed rate. During process implementation, off-line product characterisation provided additional information on key product properties related to residual moisture, solid state structure, particle size/morphology and peptide fibrillation/degradation. Results A psychrometric process model allowed the identification of feasible operating conditions for spray drying trehalose, achieving high yields of up to 84.67%, and significantly reduced levels of residual moisture and particle agglomeration compared to product obtained during non-optimal drying. The process was further translated to produce powders of glucagon and glucagon-trehalose formulations with yields of >83.24%. Extensive peptide aggregation or degradation was not observed. Conclusions The presented data-driven process development concept can be applied to address future isolation problems on lab-scale and facilitate a systematic implementation of spray drying for the manufacturing of sensitive bio-pharmaceutical formulations.
|Number of pages||19|
|Publication status||Published - 14 Dec 2020|
- spray drying
- process development
- peptide formulation
- droplet drying
- psychrometric process model
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Doctoral Training Centre In Continuous Manufacturing And Crystallisation
EPSRC (Engineering and Physical Sciences Research Council)
1/07/12 → 30/06/19
Project: Research - Studentship
Data for: "Peptide Isolation via Spray Drying: Particle Formation, Process Design and Implementation for the Production of Spray Dried Glucagon"
Doerr, F. (Creator), Burns, L. J. (Creator), Lee, B. (Creator), Hinds, J. (Creator), Davis-Harrison, R. L. (Creator), Frank, S. A. (Creator) & Florence, A. (Creator), University of Strathclyde, 30 Sept 2020