CMC Biopharma MasterClass 3.0

Join our CMC Biopharma MasterClass 3.0 on 7th and 8th May, 2019! This time we will meet in Budapest, Hungary!

This CMC Biopharma MasterClass will provide a deep and detailed instruction on Chemistry, Manufacturing and Controls (CMC) requirements and review processes for clinical trial, registration and postapproval drug applications. Attendees will also have a solid but comprehensive overview of all relevant regulatory, technical and quality elements, implementation and documentation of the required CMC analytical and stability knowledge for biotechnology products, including biosimilar products. Practical examples will be provided as illustration and proper time will be allowed for discussion designs and outcomes.

By the end of the MasterClass, the participants will understand: 

• Process Development Strategies
• Analytical and Formulation Development
• GMP Manufacture
• Process Analytical Technology
• Guidelines and Regulatory Pathways for New Biological Entities and Biosimilars

Our trainer - Dr Andreu Soldevila, founder and CEO of Leanbio and Co-founder and CEO of Syna therapeutics

Dr Andreu Soldevila is the founder and CEO of Leanbio and Co-founder and CEO of Syna therapeutics, companies dedicated to Biotherapeutics development, manufacture and commercialization. Leanbio is a CDMO founded in 2014 dedicated to both New Biologic entities and Biosimilars, whereas Syna Therapeutics is a Biotherapeutics Developer, founded in 2017 and currently has two products in the pipeline.

Dr Soldevila was responsible for a variety of technological achievements related to new microbial and mammalian expression Systems and platform for multiplex absolute quantitation of proteins by LC-MS/MS bottom-up approach at picomolar levels with proven capacity to be applied at discovery, development and manufacture of recombinant proteins and for (non)-clinical trials. In the last 10 years participated in numerous biotherapeutics projects, including 6 Biosimilar products, one of them already submitted for Market authorization license.