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Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality.
The purpose of this commentary is to provide brief summaries on the factors affecting protein aggregation and the key aspects of protein aggregation that are associated with immunogenicity, and emphasize the current scientific gaps in understanding and analytical limitations for quantitation of species of large protein aggregates that are referred to as subvisible particles.
Abstracts of papers
s of papers PARTICULATE SYSTEMS AS CARRIERS FOR SITE-SPECIFIC DRUG DELIVERY: THE STATE OF THE ART D.J.A. Crommelin In the last decade a number of particulate carrier systems have been developed to…
Structure-Immunogenicity Relationships of Therapeutic Proteins
- Suzanne Hermeling, D. Crommelin, H. Schellekens, W. Jiskoot
- BiologyPharmaceutical Research
- 1 June 2004
It is shown that physical degradation of the proteins as well as chemical decomposition may enhance the immune response, and to what extent the presence of degradation products in protein formulations influences their immunogenicity still needs further investigation.
Liposomal and Lipid Formulations of Amphotericin B
- R. Janknegt, S. Marie, I. Bakker-Woudenberg, D. Crommelin
- Biology, MedicineClinical pharmacokinetics
- 1 October 1992
There is a need for studies correlating clinical efficacy and tolerability of liposomal amphotericin B with the pharmacokinetic properties of these formulations.
The effect of a water/organic solvent interface on the structural stability of lysozyme.
Identification of Formaldehyde-induced Modifications in Proteins
The use of model peptides enabled us to determine the reactivity of each particular cross-link reaction as a function of the reaction conditions and to identify new reaction products after incubation with formaldehyde.
mRNA-lipid nanoparticle COVID-19 vaccines: Structure and stability
Workshop on Bioanalytical Methods Validation for Macromolecules: Summary Report
To address the strengths/limitations and advantages/ disadvantages of assay-customized approaches to validation that focus on assay parameters specific to the intended use of the assay, and to develop a 2000 workshop report regarding appropriate bioanalytical validation criteria and standardization of terminology.
Chemical stability of liposomes: implications for their physical stability.