This 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.

Learning Outcomes:

• Take a closer look on the new Biological entities and Biosimilars
• Experience the development of biotherapeutics from Discovery to Market approval
• Understand the Strains and Cell line development
• Have a chance to meet the Requirements and technical approach for Phase I, Phase II, Phase III clinical trials
• Learn about the Control strategy life cycle
• Understand the ICH guidelines and Regulatory pathways for New Biological entities and Biosimilars in EU and USA

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

The Trainer:       

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.

Andreu Developed as a professional in the field of Biotechnology for the last 20 years, moving from initial applied research to CMC regulatory activities, holding Bioanalysis Head of department at a multinantional company, Head of R&D in a CMO and current CEO positions.

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.