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.
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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.
Advanced Analytical Techniques: Gain proficiency in cutting-edge methods such as fluorescence spectroscopy and electron microscopy for detecting and characterizing protein aggregates
Mechanisms of Protein Aggregation: Understand the underlying processes that lead to protein aggregation, crucial for ensuring drug stability and efficacy
Impact Assessment: Evaluate the effects of protein aggregation on drug safety, efficacy, and immunogenicity, providing a comprehensive understanding of the challenges
Mitigation Strategies: Develop strategies for preventing and controlling protein aggregation, focusing on effective formulation design and problem-solving
Regulatory Compliance: Learn from case studies about regulatory guidelines and compliance requirements regarding aggregation in therapeutic protein products
Practical Application: Apply the theoretical knowledge in real-world scenarios, enhancing skills in formulation development and quality assurance in biopharmaceuticals
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Tudor Arvinte, Ph.D., received his academic training in physics at the University of Jassy, Romania, and his Ph.D. in biophysics from the University of Düsseldorf, Germany. He performed his doctoral work and postdoctoral stage at the Max-Planck-Institute West Germany and held numerous research positions in Europe and the USA: at C.N.R.S., Orléans, France, at Cornell University, New York, at Texas A&M University, and at the Biophor Corporation, College Station, Texas, USA. In 1989 he joined Ciba-Geigy Pharmaceuticals in Horsham, England, and in 1994 he moved to Ciba-Geigy in Basel, Switzerland (Novartis since 1997). Until 2002 he worked as Head of Exploratory Formulation, Novartis Biotechnology Development & Production, Basel. T. Arvinte worked on the characterization and formulation of more than 200 protein and peptide drugs. Four of his protein formulations reached the market: the formulations were developed using High Throughput Analytic (HTA) and High Throughput Formulation (HTF) methods developed by T Arvinte. T. Arvinte has 90 publications, 12 book chapters, holds 15 patents on formulations of proteins, and gave more than 490 invited lectures at scientific meetings, regulatory bodies, and pharmaceutical companies. T. Arvinte was Titular Professor at the School of Pharmacy, University of Geneva, Switzerland where he is teaching a post-graduate course on “Formulation and delivery of protein biopharmaceuticals” until 2023. He co-founded Therapeomic, Inc., a biotech company focused on developing formulations for biopharmaceuticals in collaborations with pharmaceutical companies.
