Alternative drying technologies for biologics
Osanloo, Daniel LU
(2024)
- Abstract
- This doctoral thesis aims to investigate and compare conventional drying technologies (freeze-drying and spray drying) to alternative drying technologies for biologics. Vacuum foam-drying was identified as an alternative drying technology for biologics. Vacuum foam-drying is a drying technique that involves solvent removal by evaporation, at lowered pressure and ambient temperatures. Thus, vacuum foam-drying can provide milder drying conditions for thermal-sensitive biologics, such as proteins. A matrix system with glassy properties is necessary to ensure good reconstitution attributes, but also by beneficially interacting with the protein provides good protein stability. As vacuum foam-drying is quite unexplored, this thesis aims to... (More)
- This doctoral thesis aims to investigate and compare conventional drying technologies (freeze-drying and spray drying) to alternative drying technologies for biologics. Vacuum foam-drying was identified as an alternative drying technology for biologics. Vacuum foam-drying is a drying technique that involves solvent removal by evaporation, at lowered pressure and ambient temperatures. Thus, vacuum foam-drying can provide milder drying conditions for thermal-sensitive biologics, such as proteins. A matrix system with glassy properties is necessary to ensure good reconstitution attributes, but also by beneficially interacting with the protein provides good protein stability. As vacuum foam-drying is quite unexplored, this thesis aims to investigate and highlight: 1) the formation of a solid material; 2) how the formulation parameters and process conditions impact the product properties (reconstitution and stability of proteins); 3) the surface distribution upon the formation of a solid material and the internal distribution of the components in the dry material.
Upon drying, vacuum foam-drying generates a solid foam with thick walls, at least four times thicker than the wall thickness of a freeze-dried material. This is interesting since the thicker walls can fully encapsulate larger biologics such as cells and bacteria. Even though thicker walls, the reconstitution characteristics of the solid foam were good and similar to the corresponding freeze-dried material. Moreover, a glassy matrix was necessary to preserve the stability of the protein. Freeze-drying, spray drying, and vacuum foam-drying processes can all be designed to preserve the stability of proteins in an amorphous matrix. Furthermore, the surface composition of the vacuum foam-dried lamellae is heterogeneous, and forms domains enriched in protein, and other domains enriched in the carbohydrate matrix. The internal composition highlights the phase separation of macromolecular components, protein and polysaccharide polymer, which may result in reduced protein stability.
In conclusion, vacuum foam-drying shows promise as an alternative drying technology for proteins, and if used correctly may be used as a concept for most dry biologics. (Less)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/955fff3d-8187-41f1-98c0-303c6ef785e2
- author
- Osanloo, Daniel
LU
- supervisor
- opponent
-
- Prof. Juppo, Anne, University of Helsinki, Finland.
- organization
- publishing date
- 2024
- type
- Thesis
- publication status
- published
- subject
- pages
- 71 pages
- publisher
- Department of Process and Life Science Engineering, Lund University.
- defense location
- Lecture Hall KC:A, Kemicentrum, Naturvetarvägen 14, Faculty of Engineering LTH, Lund University, Lund. The dissertation will be live streamed, but part of the premises is to be excluded from the live stream.
- defense date
- 2024-06-12 09:00:00
- ISBN
- 978-91-8096-056-4
- 978-91-8096-057-1
- language
- English
- LU publication?
- yes
- id
- 955fff3d-8187-41f1-98c0-303c6ef785e2
- date added to LUP
- 2024-05-16 13:27:00
- date last changed
- 2024-05-23 14:17:22
@phdthesis{955fff3d-8187-41f1-98c0-303c6ef785e2,
abstract = {{This doctoral thesis aims to investigate and compare conventional drying technologies (freeze-drying and spray drying) to alternative drying technologies for biologics. Vacuum foam-drying was identified as an alternative drying technology for biologics. Vacuum foam-drying is a drying technique that involves solvent removal by evaporation, at lowered pressure and ambient temperatures. Thus, vacuum foam-drying can provide milder drying conditions for thermal-sensitive biologics, such as proteins. A matrix system with glassy properties is necessary to ensure good reconstitution attributes, but also by beneficially interacting with the protein provides good protein stability. As vacuum foam-drying is quite unexplored, this thesis aims to investigate and highlight: 1) the formation of a solid material; 2) how the formulation parameters and process conditions impact the product properties (reconstitution and stability of proteins); 3) the surface distribution upon the formation of a solid material and the internal distribution of the components in the dry material. <br/><br/>Upon drying, vacuum foam-drying generates a solid foam with thick walls, at least four times thicker than the wall thickness of a freeze-dried material. This is interesting since the thicker walls can fully encapsulate larger biologics such as cells and bacteria. Even though thicker walls, the reconstitution characteristics of the solid foam were good and similar to the corresponding freeze-dried material. Moreover, a glassy matrix was necessary to preserve the stability of the protein. Freeze-drying, spray drying, and vacuum foam-drying processes can all be designed to preserve the stability of proteins in an amorphous matrix. Furthermore, the surface composition of the vacuum foam-dried lamellae is heterogeneous, and forms domains enriched in protein, and other domains enriched in the carbohydrate matrix. The internal composition highlights the phase separation of macromolecular components, protein and polysaccharide polymer, which may result in reduced protein stability.<br/><br/>In conclusion, vacuum foam-drying shows promise as an alternative drying technology for proteins, and if used correctly may be used as a concept for most dry biologics.}},
author = {{Osanloo, Daniel}},
isbn = {{978-91-8096-056-4}},
language = {{eng}},
publisher = {{Department of Process and Life Science Engineering, Lund University.}},
school = {{Lund University}},
title = {{Alternative drying technologies for biologics}},
url = {{https://lup.lub.lu.se/search/files/183608766/Daniel_Tristan_Osanloo_-_Kappa.pdf}},
year = {{2024}},
}