In this intensive masterclass, "Mastering Biopharmaceutical Analytical Characterization with ICH Q6B", the technical, regulatory, and commercial aspects of biopharmaceutical characterization will be covered. The course content is designed to provide valuable assistance to scientists working in or entering the biopharma space.
Through interactive sessions, attendees will gain an understanding of large molecule drug development and the analytical techniques required to determine recombinant protein structure for both innovative and biosimilar products.
With particular relevance for those seeking to understand the differences between small and large molecule development, improve their knowledge of required characterization methods, and strategically plan analytical approaches, this course will enable participants to master biopharmaceutical product characterization according to current industry practices and regulatory guidelines.
Detailed reviews of techniques for assessing primary structure, post-translational modifications, higher order structure, and other critical quality attributes will demystify the array of analyses needed to adequately define novel and biosimilar biologic structure. Expert perspectives on meeting regulatory expectations will prepare attendees to plan and execute characterization studies that withstand scrutiny.
Learning Objectives
Fundamental Insights: Grasp the nuances of biopharmaceuticals, manufacturing processes, and regulatory essentials.
Analytical Challenges: Address critical questions about large complex molecules and understand protein and glycoprotein chemistry.
Detailed Product Characterization: Explore analytical methods for amino acid sequences, glycosylation, and more.
Physicochemical Mastery: Analyze molecular weight, size, isoform patterns, and delve into post-translational modifications.
Biosimilars Exploration: Gain insights into biosimilars, global regulations, and establishing biosimilarity.
Real-World Application: Conclude with case studies for a practical understanding.
Through interactive sessions, attendees will gain an understanding of large molecule drug development and the analytical techniques required to determine recombinant protein structure for both innovative and biosimilar products.
With particular relevance for those seeking to understand the differences between small and large molecule development, improve their knowledge of required characterization methods, and strategically plan analytical approaches, this course will enable participants to master biopharmaceutical product characterization according to current industry practices and regulatory guidelines.
Detailed reviews of techniques for assessing primary structure, post-translational modifications, higher order structure, and other critical quality attributes will demystify the array of analyses needed to adequately define novel and biosimilar biologic structure. Expert perspectives on meeting regulatory expectations will prepare attendees to plan and execute characterization studies that withstand scrutiny.
Learning Objectives
Fundamental Insights: Grasp the nuances of biopharmaceuticals, manufacturing processes, and regulatory essentials.
Analytical Challenges: Address critical questions about large complex molecules and understand protein and glycoprotein chemistry.
Detailed Product Characterization: Explore analytical methods for amino acid sequences, glycosylation, and more.
Physicochemical Mastery: Analyze molecular weight, size, isoform patterns, and delve into post-translational modifications.
Biosimilars Exploration: Gain insights into biosimilars, global regulations, and establishing biosimilarity.
Real-World Application: Conclude with case studies for a practical understanding.
