Industry Session
Nathalie Gonzalez
Principal Scientist Innovation Center
Corbion
Julien Bérard
Global Head of Business Biomaterials
Corbion
Developing, scaling up, and reliably producing resorbable polymers for controlled drug release requires a deep understanding of material behavior, process parameters, and regulatory expectations. This presentation will outline Corbion’s strategic approach to supporting customers through every stage of polymer development, from early-stage formulation to commercial production, while ensuring consistency, scalability, and compliance.
The session will begin with our business development strategies, followed by a technical dive into innovative methodologies for achieving robust and predictable drug release. Traditional approaches often rely on empirical strategies learned during PhD research, such as varying copolymer ratios and intrinsic viscosities while assuming material equivalency at scale. In contrast, this talk will illustrate a more structured approach using a general case study to define Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs), leverage scale-up and scale-down experiments, and establish a comprehensive Design Space.
Attendees will gain insights into how Corbion integrates advanced tools such as Design of Experiments (DoE), in line spectroscopic techniques, and Multivariate Data Analysis to enhance process understanding and ensure batch-to-batch consistency. Additionally, we will highlight the critical role of process validation (PV) in confirming control strategies at a commercial scale. By combining cutting-edge analytical techniques with a science-driven approach to manufacturing, Corbion empowers customers to bring innovative drug delivery solutions to market with confidence.