Short Courses

SC1: Continuous and Integrated Bioprocessing Masterclass - Detailed Agenda

Instructor: Margit Holzer, PhD, Owner, Ulysse Consult

The manufacture of biopharmaceuticals using semi- or fully continuous processes has the potential to improve product quality and increase the productivity of biomanufacturing facilities. This short course details the principles and practical challenges of implementing a continuous process strategy. Using examples and shared experiences, the course covers continuous processing definitions and drivers, technologies and processes, process development and control, and quality considerations.

SC2: Potency Assays for Cell and Gene Therapies - Detailed Agenda

Instructor: Christopher Bravery, PhD, Consulting Regulatory Scientist, Consulting on Advanced Biologicals Ltd.

Potency assays are an essential concept in determining the quality of any biological medicinal product/biologic. Extending this concept to cell and gene products is more challenging and often the most difficult aspect of characterising these products. The relevance of the approach taken is often challenged by regulators both during development and when seeking market approval. This workshop will lead you through the issues and how to develop an overall potency strategy.

SC4: Quality Considerations for Gene Therapy Viral Vectors - Detailed Agenda

Instructor: Christopher Bravery, PhD, Consulting Regulatory Scientist, Consulting on Advanced Biologicals Ltd.

Gene therapy viral vectors are complex biological medicinal products which pose a number of challenges with respect to quality and overall adventitious agent safety. Firstly, they are large complex viral particles which must be designed to be replicationincompetent. Secondly, as the product is a suspension of viral particles, application of traditional viral reduction and elimination steps is not possible, so control of materials and the process become more important. This course outlines the testing expected to address these fundamental features and ensure a safe product of suitable quality is released.

SC6: Understanding Chromatography to Design Efficient Bioprocesses with a Predictive Approach - Detailed Agenda

Instructors: Hector Osuna, PhD, Head of Biotech Modeling, Ypso-Facto
Lucrèce Nicoud, PhD, Project Manager, Ypso-Facto

Preparative chromatography is at the heart of the purification of biopharmaceuticals, both for capture and polishing steps, which mostly rely on affinity, hydrophobic interactions and/ or ion exchange mechanisms. This short course will describe a rational approach to design efficient chromatographic processes on the basis of mechanistic modeling. It will highlight the main physicochemical phenomena involved, their impact on the separation and differences between process configurations (from single to multi-column). This methodology combines well targeted experiments and smart simulation tools to develop reliable and robust processes in a predictive way at different scales.