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

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第一作者： Miguel,Saggu

第一单位： Pharmaceutical Development, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA. Electronic address: saggu.miguel@gene.com.

作者： Miguel,Saggu ^[1] ; George M,Bou-Assaf ^[2] ; Reinhard,Bucher ^[3] ; Ivan L,Budyak ^[4] ; Jakob,Buecheler ^[5] ; Shawn,Cao ^[6] ; Minna,Groenning ^[7] ; Emon,Khan ^[8] ; Stanley C,Kwok ^[9] ; Shalini,Minocha ^[10] ; Karthik,Pisupati ^[4] ; Vinay,Radhakrishnan ^[10] ; Nicoline,Videbæk ^[11] ; Dennis T,Yang ^[4] ; Bin,Zhang ^[10] ; Linda O,Narhi ^[12]

作者单位： Pharmaceutical Development, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA. Electronic address: saggu.miguel@gene.com. ^[1] Analytical Development, Biogen, Cambridge, Massachusetts, USA. ^[2] Product Development Safety, Clinical Safety, F. Hoffmann-La Roche, Basel, Switzerland. ^[3] Biopharmaceutical Research and Development, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285, USA. ^[4] Technical Research and Development, Novartis Pharma AG, 4002 Basel, Switzerland. ^[5] Process Development, Amgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA 91320, USA. ^[6] CMC Biophysical Analysis, Novo Nordisk A/S, Novo Nordisk Park, Måløv, Denmark. ^[7] Late Respiratory and Immunology, AstraZeneca, Academy House, Cambridge, UK. ^[8] Dosage Form Design & Development, BioPharmaceuticals Development, AstraZeneca, One Medimmune Way, Gaithersburg, Maryland 20878, USA. ^[9] Injectable Drug Product Development, Alexion, AstraZeneca Rare Disease, 121 Seaport Blvd, Boston, Massachusetts, USA. ^[10] Clinical Immunogenicity Analysis, Novo Nordisk A/S, Novo Nordisk Park, Måløv, Denmark. ^[11] BioPhia Consulting, USA. Electronic address: lnarhi@BioPhia.com. ^[12]

关键词 Analytical impact Clinical impact Silicone oil Subvisible particles, case studies

主题词人类(Humans);硅油类(Silicone Oils);粒子大小(Particle Size);药用制剂(Pharmaceutical Preparations);颗粒物(Particulate Matter);生物制品(Biological Products);注射器(Syringes)

DOI 10.1016/j.xphs.2024.01.002

PMID 38220088

发布时间 2025-03-26

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准确一般字义偏差语意偏离译文作用小提交