Bloc: Regulations & quality and bioproduction

Impurities and Contaminants in Biotechnological Products: Sources, Prevention, and Problem Solving

Annex 1: sterile filtration and integrity testing

Develop quality tools to control the process

Continuous process improvement: the contribution of PAT to the quality by design approach

Design of Experiments for QbD

Hands-on application of Quality by Design using a specialized platform

Introduction to the culture of good manufacturing practices

Introduction to data integrity concepts in the biopharmaceutical industry

Regulatory prerequisites for entering clinical development

Technology transfer and process industrialization

Evaluating the Developability of a Biopharmaceutical: CMC from Molecule to Bioprocess

Quality by Design Applied to Analytical Methods (AQbD): Toward a Scientific and Effective Approach to Analytical Processes

Fundamentals of Quality by Design to Strengthen Your Company’s R&D

Bioprocessing: Downstream Process and Drug Product Development

Bioprocessing: Upstream Process – from Hybridoma to Clarification

Introduction to biomolecules and their bioproduction