meet the training leader
Prof. Dr. Tudor Arvinte
Titular Professor of Biopharmaceutics, School of Pharmaceutical Sciences, University of Geneva, and CEO, Therapeomic, Inc.
Switzerland
This course is not currently scheduled but may be offered at your company site.
Please contact Fleming for more information.
All sessions of this unique course online
Live interaction options between the delegates and trainer
Available via mobile, tablet or laptop
Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!
Complexity and diversity of protein aggregates in biopharmaceuticals
Principles of different methods for analysis of aggregation and particulate matter
Importance of formulation for the market success of biopharmaceuticals
In use compatibility studies
Compatibility of biopharmaceuticals with primary packaging: characterization of leachables and extractables
Studies of aggregates formation after mixing biopharmaceuticals with human plasma and human blood: Implications for in vivo toxicity and immunogenicity
Examples of biopharmaceuticals will include: peptides, small proteins, antibodies, large proteins, biosimilars, different vaccines (based on proteins, nanoparticles, viruses)
Regulatory aspects regarding aggregates and particulates
Understand
• Risk management and preventive actions concerning particulates
• Critical process and formulation parameters
• How to assess aggregates
Learn
• New orthogonal analytical method
• Factors that induce protein aggregation and particulate formation in drug substances and drug products
• Case studies of biopharmaceuticals in development and on the market
Gain
• Knowledge on utility and limits of predictive experiments
• Insight into the diversity of aggregates and particulates present in biopharmaceuticals revealed by new orthogonal methods
• Methods to study the aggregation of biopharmaceuticals in human plasma and human blood
This course is not currently scheduled but may be offered at your company site.
Please contact Fleming for more information.
