article Open AccessTop 10% cited
Overlooking Subvisible Particles in Therapeutic Protein Products: Gaps That May Compromise Product Quality
Journal of Pharmaceutical Sciences · 2008 · Vol. 98(4) · pp. 1201–1205
John F. Carpenter✉(University of Colorado Health)Theodore W. Randolph(University of Colorado Boulder)Wim Jiskoot(Leiden University)Daan J.A. Crommelin(Utrecht University)C. Russell Middaugh(University of Kansas)Gerhard Winter(Ludwig-Maximilians-Universität München)Ying‐Xin Fan(Center for Drug Evaluation and Research)Susan Kirshner(Center for Drug Evaluation and Research)Daniela Verthelyi(Center for Drug Evaluation and Research)Steven Kozlowski(United States Food and Drug Administration)Kathleen A. Clouse(United States Food and Drug Administration)Patrick G. Swann(United States Food and Drug Administration)Amy S. Rosenberg(Center for Drug Evaluation and Research)Barry Cherney(Center for Drug Evaluation and Research)
Protein purification and stabilityMonoclonal and Polyclonal Antibodies ResearchTransgenic Plants and ApplicationsMedicineImmunogenicityHaemophiliaScopusAntibodyFactor IXImmunologyPharmacologyMEDLINEInternal medicine
MeSH terms
Consumer Product SafetyDrug ContaminationDrug StabilityDrug StoragePharmaceutical PreparationsParticle SizeQuality ControlRecombinant ProteinsDrug-Related Side Effects and Adverse Reactions
Citations
582
FWCI
10.07
field-weighted impact
References
20
Percentile
99%
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Citations per year
Cited by
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References
Physical Stability of Proteins in Aqueous Solution: Mechanism and Driving Forces in Nonnative Protein Aggregation
Pharmaceutical Research · 2003 · 1,362 citations
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