Comparison of protein-like model particles fabricated by micro 3D printing to established standard particles
Author (Corporation)
Publication date
08/2024
Typ of student thesis
Course of study
Collections
Type
01A - Journal article
Editors
Editor (Corporation)
Supervisor
Parent work
Journal of Pharmaceutical Sciences
Special issue
DOI of the original publication
Link
Series
Series number
Volume
113
Issue / Number
8
Pages / Duration
2394-2404
Patent number
Publisher / Publishing institution
Elsevier
Place of publication / Event location
Edition
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Abstract
Innovative analytical instruments and development of new methods has provided a better understanding of protein particle formation in biopharmaceuticals but have also challenged the ability to obtain reproducible and reliable measurements. The need for protein-like particle standards mimicking the irregular shape, translucent nature and near-to-neutral buoyancy of protein particles remained one of the hot topics in the field of particle detection and characterization in biopharmaceutical formulations. An innovative protein-like particle model has been developed using two photo polymerization (2PP) printing allowing to fabricate irregularly shaped particles with similar properties as protein particles at precise size of 50 µm and 150 µm, representative of subvisible particles and visible particles, respectively.
A study was conducted to compare the morphological, physical, and optical properties of artificially generated protein particles, polystyrene spheres, ETFE, and SU-8 particle standards, along with newly developed protein-like model particles manufactured using 2PP printing.
Our results suggest that 2PP printing can be used to produce protein-like particle standards that might facilitate harmonization and standardization of subvisible and visible protein particle characterization across laboratories and organizations.
Keywords
Subject (DDC)
600 - Technik, Medizin, angewandte Wissenschaften
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ISBN
ISSN
0022-3549
1520-6017
1520-6017
Language
English
Created during FHNW affiliation
Yes
Strategic action fields FHNW
Publication status
Published
Review
Peer review of the complete publication
Open access category
Hybrid
License
Citation
AMARA, Ilias, Oliver GERMERSHAUS, Christopher LENTES, Steffen SASS, Stephany Mamdjo YOUMTO, Jan Olaf STRACKE, Mirjam CLEMENS-HEMMELMANN und Anacelia ASSFALG, 2024. Comparison of protein-like model particles fabricated by micro 3D printing to established standard particles. Journal of Pharmaceutical Sciences. August 2024. Bd. 113, Nr. 8, S. 2394–2404. DOI 10.1016/j.xphs.2024.04.011. Verfügbar unter: https://doi.org/10.26041/fhnw-11823