Research output per year
Research output per year
Description
This is a collection of data and methodologies used in the following publication. Public access to the dataset is currently under embargo until 01/01/2021. Expressions of interest can be made via the contact email: [email protected]. Further details on the data can be found in the README file provided.
Title: Peptide Isolation via Spray Drying: Particle Formation, Process Design and Implementation for the Production of Spray Dried Glucagon
Authors: Frederik J. S. Doerr, Lee J. Burns, Becky Lee, Jeremy Hinds, Rebecca L. Davis-Harrison, Scott A. Frank, Alastair J. Florence
Journal: Pharmaceutical Research
Accepted Date: 28/09/2020
DOI: https://doi.org/10.1007/s11095-020-02942-5
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.
Title: Peptide Isolation via Spray Drying: Particle Formation, Process Design and Implementation for the Production of Spray Dried Glucagon
Authors: Frederik J. S. Doerr, Lee J. Burns, Becky Lee, Jeremy Hinds, Rebecca L. Davis-Harrison, Scott A. Frank, Alastair J. Florence
Journal: Pharmaceutical Research
Accepted Date: 28/09/2020
DOI: https://doi.org/10.1007/s11095-020-02942-5
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.
| Date made available | 30 Sept 2020 |
|---|---|
| Publisher | University of Strathclyde |
| Date of data production | 1 Sept 2018 - 31 Mar 2019 |
Research output
- 1 Article
-
Peptide isolation via spray drying: particle formation, process design and implementation for the production of spray dried glucagon
Doerr, F. J. S., Burns, L. J., Lee, B., Hinds, J., Davis-Harrison, R. L., Frank, S. A. & Florence, A. J., 14 Dec 2020, In: Pharmaceutical Research. 37, 12, 19 p., 255.Research output: Contribution to journal › Article › peer-review
Open AccessFile9 Citations (Scopus)54 Downloads (Pure)
Projects
- 2 Finished
-
Future Continuous Manufacturing and Advanced Crystallisation Research Hub (CMAC Hub)
Florence, A. (Principal Investigator), Brown, C. (Co-investigator), Halbert, G. (Co-investigator), Johnston, B. (Co-investigator), Markl, D. (Co-investigator), Nordon, A. (Co-investigator), Price, C. J. (Co-investigator), Sefcik, J. (Co-investigator) & Ter Horst, J. (Co-investigator)
EPSRC (Engineering and Physical Sciences Research Council)
1/01/17 → 30/09/24
Project: Research
-
Doctoral Training Centre In Continuous Manufacturing And Crystallisation
Florence, A. (Principal Investigator) & Sefcik, J. (Co-investigator)
EPSRC (Engineering and Physical Sciences Research Council)
1/07/12 → 30/06/19
Project: Research - Studentship