Evaluating Clinical Safety and Analytical Impact of Subvisible Silicone Oil Particles in Biopharmaceutical Products.

Autor:	Saggu M; Pharmaceutical Development, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA. Electronic address: saggu.miguel@gene.com., Bou-Assaf GM; Analytical Development, Biogen, Cambridge, Massachusetts, USA., Bucher R; Product Development Safety, Clinical Safety, F. Hoffmann-La Roche, Basel, Switzerland., Budyak IL; Biopharmaceutical Research and Development, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285, USA., Buecheler J; Technical Research and Development, Novartis Pharma AG, 4002 Basel, Switzerland., Cao S; Process Development, Amgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA 91320, USA., Groenning M; CMC Biophysical Analysis, Novo Nordisk A/S, Novo Nordisk Park, Måløv, Denmark., Khan E; Late Respiratory and Immunology, AstraZeneca, Academy House, Cambridge, UK., Kwok SC; Dosage Form Design & Development, BioPharmaceuticals Development, AstraZeneca, One Medimmune Way, Gaithersburg, Maryland 20878, USA., Minocha S; Injectable Drug Product Development, Alexion, AstraZeneca Rare Disease, 121 Seaport Blvd, Boston, Massachusetts, USA., Pisupati K; Biopharmaceutical Research and Development, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285, USA., Radhakrishnan V; Injectable Drug Product Development, Alexion, AstraZeneca Rare Disease, 121 Seaport Blvd, Boston, Massachusetts, USA., Videbæk N; Clinical Immunogenicity Analysis, Novo Nordisk A/S, Novo Nordisk Park, Måløv, Denmark., Yang DT; Biopharmaceutical Research and Development, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285, USA., Zhang B; Injectable Drug Product Development, Alexion, AstraZeneca Rare Disease, 121 Seaport Blvd, Boston, Massachusetts, USA., Narhi LO; BioPhia Consulting, USA. Electronic address: lnarhi@BioPhia.com.
Jazyk:	angličtina
Zdroj:	Journal of pharmaceutical sciences [J Pharm Sci] 2024 May; Vol. 113 (5), pp. 1401-1414. Date of Electronic Publication: 2024 Jan 12.
DOI:	10.1016/j.xphs.2024.01.002
Abstrakt:	Silicone oil is a commonly used lubricant in pre-filled syringes (PFSs) and can migrate over time into solution in the form of silicone oil particles (SiOPs). The presence of these SiOPs can result in elevated subvisible particle counts in PFS drug products compared to other drug presentations such as vials or cartridges. Their presence in products presents analytical challenges as they complicate quantitation and characterization of other types of subvisible particles in solution. Previous studies have suggested that they can potentially act as adjuvant resulting in potential safety risks for patients. In this paper we present several analytical case studies describing the impact of the presence of SiOPs in biotherapeutics on the analysis of the drug as well as clinical case studies examining the effect of SiOPs on patient safety. The analytical case studies demonstrate that orthogonal techniques, especially flow imaging, can help differentiate SiOPs from other types of particulate matter. The clinical case studies showed no difference in the observed patient safety profile across multiple drugs, patient populations, and routes of administration, indicating that the presence of SiOPs does not impact patient safety. (Copyright © 2024 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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