Data for: "Peptide Isolation via Spray Drying: Particle Formation, Process Design and Implementation for the Production of Spray Dried Glucagon"

  • Frederik Doerr (Creator)
  • Lee J. Burns (Creator)
  • Becky Lee (Creator)
  • Jeremy Hinds (Creator)
  • Rebecca L. Davis-Harrison (Creator)
  • Scott A. Frank (Creator)
  • Alastair Florence (Creator)

Dataset

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: researchdataproject@strath.ac.uk. 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: (tbc)

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 available30 Sep 2020
PublisherUniversity of Strathclyde
Date of data production1 Sep 2018 - 31 Mar 2019

Research Output

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., 27 Sep 2020, (Accepted/In press) In : Pharmaceutical Research.

Research output: Contribution to journalArticle

  • Projects

    Cite this

    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) (30 Sep 2020). Data for: "Peptide Isolation via Spray Drying: Particle Formation, Process Design and Implementation for the Production of Spray Dried Glucagon". University of Strathclyde. 10.15129/dcb859db-fe0d-4a56-b001-3f3d7ac6c44a