Peptide isolation via spray drying : particle formation, process design and implementation for the production of spray dried glucagon

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Doerr, Frederik J. S. and Burns, Lee J. and Lee, Becky and Hinds, Jeremy and Davis-Harrison, Rebecca L. and Frank, Scott A. and Florence, Alastair J. (2020) Peptide isolation via spray drying : particle formation, process design and implementation for the production of spray dried glucagon. Pharmaceutical Research, 37 (12). 255. ISSN 0724-8741 (https://doi.org/10.1007/s11095-020-02942-5)

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Abstract

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.

ORCID iDs

Doerr, Frederik J. S. ORCID logoORCID: https://orcid.org/0000-0001-5245-0503, Burns, Lee J., Lee, Becky, Hinds, Jeremy, Davis-Harrison, Rebecca L., Frank, Scott A. and Florence, Alastair J. ORCID logoORCID: https://orcid.org/0000-0002-9706-8364;
CORE (COnnecting REpositories)