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
Benefits of attending
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 is my third course with Fleming and believe that they are the best in terms of relevancy and content. The course gives deep insight into protein aggregation mechanisms and analysis techniques. The content was excellent with a good balance between theoretical explanation and case studies, which will help me in applying the learned techniques into the adopted strategy of biosimilars development inside my company.
Rana El BazMinapharm
This course is a high quality and in depth learning which gave me a lot of work relevant knowledge.
There was a long time since I learned so much on a course as I did with Professor Tudor Arvinte in this Fleming event. Thanks!
Igor OruetxebarriaKCT Kuopio Center for Cell & Gene Therapies