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An Intra-Company Analysis of Inherent Particles in Biologicals Shapes the Protein Particle Mitigation Strategy Across Development Stages.
- Source :
-
Journal of pharmaceutical sciences [J Pharm Sci] 2023 May; Vol. 112 (5), pp. 1476-1484. Date of Electronic Publication: 2023 Jan 31. - Publication Year :
- 2023
-
Abstract
- To better understand protein aggregation and inherent particle formation in the biologics pipeline at Novartis, a cross-functional team collected and analyzed historical protein particle issues. Inherent particle occurrences from the past 10 years were systematically captured in a protein particle database. Where the root cause was identified, a number of product attributes (such as development stage, process step, or protein format) were trended. Several key themes were revealed: 1) there was a higher propensity for inherent particle formation with non-mAbs than with mAbs; 2) the majority of particles were detected following manufacturing at scale, and were not predicted by the small-scale studies; 3) most issues were related to visible particles, followed by subvisible particles; 4) 50% of the issues were manufacturing related. These learnings became the foundation of a particle mitigation strategy across development and technical transfer, and resulted in a set of preventive actions. Overall, this study provides further insight into a recognized industry challenge and hopes to inspire the biopharmaceutical industry to transparently share their experiences with inherent particles formation.<br /> (Copyright © 2023 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Particle Size
Antibodies, Monoclonal
Protein Aggregates
Biological Products
Subjects
Details
- Language :
- English
- ISSN :
- 1520-6017
- Volume :
- 112
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Journal of pharmaceutical sciences
- Publication Type :
- Academic Journal
- Accession number :
- 36731778
- Full Text :
- https://doi.org/10.1016/j.xphs.2023.01.023