Tuesday August 16
SC7: Purification of Advanced Medicine Therapy Products
Advanced Therapy Medicinal Products (ATMPs), defined as stem cell-based products, virus and virus-like particles, have a unique complexity that challenges the design of robust and effective biomanufacturing processes. Already established downstream processing steps should be rethought and redesigned to cope with the specific demands for these types of therapeutic products, maintaining their final quality attributes in terms of identity, potency, purity and safety.
In this short course we will provide a comprehensive and detailed outline of hands-on issues for ATMPs´ purification and an overview of the main challenges that these type of products pose and how we can tailor current processes to fit their particular requirements.
What Attendees Will Learn from this Course:
- Understand the unique complexity of ATMPs and what are key elements to design a successful purification strategy;
- Impact of process parameters on the final product quality;
- Apply the latest tools, technologies and methodologies to identify and overcome purification bottlenecks;
- Outline the legal and ethical restrictions placed by the regulatory agencies for the development, production and delivery of novel ATMPs.
Ricardo Silva, Ph.D., Researcher, Downstream Processing Lab, Animal Cell Technology, iBET – Instituto de Biologia Experimental e Tecnologica
Barbara Cunha, MSc., Ph.D. Student, Animal Cell Technology, iBET - Instituto de Biologia Experimental e Tecnologica
Ricardo Silva received his PhD degree in Chemical and Biochemical Engineering from New University of Lisbon in 2013. His studies focused on the development and optimization of countercurrent adsorption processes for purification of (bio)pharmaceutical products. Since 2014 he is a researcher at Animal Cell Technology Unit in iBET, pursuing the development of continuous purification processes and identification of new purification strategies for vaccines, gene therapy vectors and cell based products.
Bárbara Cunha studied Biochemistry at Faculdade de Ciências da Faculdade de Lisboa untill 2009 and completed her Master in Biotechnology in 2011. Currently, she’s a PhD student at MIT-Portugal Bio-Engineering Systems Program where she’s working at iBET on the development of scalable and integrated strategies for the downstream processing of human stem cells for clinical application.