The "Particles and Protein Aggregation in Parenteral Products Masterclass" delves into the multifaceted world of protein aggregation in biopharmaceuticals. This comprehensive course, structured over three detailed half-days, is an exploration into both the theoretical and practical aspects of protein aggregation. Participants will be introduced to a variety of protein aggregates, their formation mechanisms, and the critical impact they have on drug development and patient safety. The training emphasizes the importance of understanding these aggregates in the context of therapeutic protein products.
The course introduces participants to advanced analytical methods, including novel techniques developed by Therapeomic. These methods are crucial for the detailed physicochemical analysis of pharmaceuticals, aiding in the identification and characterization of protein aggregates. The curriculum is further enriched with discussions on high throughput analysis and formulation, equipping attendees with the necessary tools for effective protein formulation development. Throughout the training, participants will engage in interactive sessions, case studies, and practical workshops, providing a well-rounded educational experience that is both intellectually stimulating and professionally beneficial
Participants will also be able to delve into mitigation strategies and formulation development, offering practical insights into preventing and controlling protein aggregation. This includes a focus on formulation design principles, compatibility studies, and regulatory guidelines, equipping attendees with the tools they need to navigate the complex landscape of parenteral product development. Under the expert guidance of Prof. Dr. Tudor Arvinte, this course promises to be an enlightening and essential experience for professionals in the biopharmaceutical industry.
Key Highlights
Cutting-Edge Analytical Techniques: Exploration of modern methods like fluorescence spectroscopy for precise protein aggregate analysis.
Understanding Aggregation Dynamics: Detailed examination of the causes and development of protein aggregates in parenteral products.
Evaluating Aggregate Impact: Analysis of how aggregates affect the quality, safety, and therapeutic efficacy of biopharmaceuticals.
Strategies for Aggregate Reduction: Focus on innovative approaches to minimize protein aggregation during product development.
Regulatory Aspects on Protein Aggregates: Understand the regulatory guidelines and compliance requirements for therapeutic protein products.
Case Studies and Practical Workshops: Interactive sessions providing real-life examples and hands-on experience in tackling aggregation challenges.
The course introduces participants to advanced analytical methods, including novel techniques developed by Therapeomic. These methods are crucial for the detailed physicochemical analysis of pharmaceuticals, aiding in the identification and characterization of protein aggregates. The curriculum is further enriched with discussions on high throughput analysis and formulation, equipping attendees with the necessary tools for effective protein formulation development. Throughout the training, participants will engage in interactive sessions, case studies, and practical workshops, providing a well-rounded educational experience that is both intellectually stimulating and professionally beneficial
Participants will also be able to delve into mitigation strategies and formulation development, offering practical insights into preventing and controlling protein aggregation. This includes a focus on formulation design principles, compatibility studies, and regulatory guidelines, equipping attendees with the tools they need to navigate the complex landscape of parenteral product development. Under the expert guidance of Prof. Dr. Tudor Arvinte, this course promises to be an enlightening and essential experience for professionals in the biopharmaceutical industry.
Key Highlights
Cutting-Edge Analytical Techniques: Exploration of modern methods like fluorescence spectroscopy for precise protein aggregate analysis.
Understanding Aggregation Dynamics: Detailed examination of the causes and development of protein aggregates in parenteral products.
Evaluating Aggregate Impact: Analysis of how aggregates affect the quality, safety, and therapeutic efficacy of biopharmaceuticals.
Strategies for Aggregate Reduction: Focus on innovative approaches to minimize protein aggregation during product development.
Regulatory Aspects on Protein Aggregates: Understand the regulatory guidelines and compliance requirements for therapeutic protein products.
Case Studies and Practical Workshops: Interactive sessions providing real-life examples and hands-on experience in tackling aggregation challenges.
