Short Courses

Monday 23 March 2020, 13:00 - 16:00

SC1: Continuous and Integrated Bioprocessing Masterclass

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

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.

SC3: Technical Development of T Cell-Based Immunotherapies – Considerations and Lessons Learned

Instructor: Ali Mohamed, PhD, Vice President, CMC, Immatics

During the development of multiple T cell-based cellular immunotherapies at Immatics, many experiences have been gained and lessons learned. The workshop will focus on the various aspects of process development and GMP manufacturing of these T cell products including starting cell or tissue, raw material including viral vectors, manufacturing systems, assay development and validation, release testing specification, as well as the regulatory aspects involved.

Wednesday 25 March 2020, 18:30 – 21:00

SC4: Quality Considerations for Gene Therapy Viral Vectors

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.

SC5: Saving Time in Process Development with Next-Generation Methods: PAT, Hybrid Modeling, Process Simulation, mDoE, and iDoE

Instructors: Moritz von Stosch, PhD, Senior Manager, Drug Substance, Technical R&D, GSK Vaccines
Mark Dürkop, PhD, Project Leader, Biotechnology, University of Natural Resources and Life Sciences, Vienna (BOKU); Co- Founder and CEO, Novasign, Inc.

In this short course, we show how a more accurate design space can be defined that provides increased flexibility for process operation based on the iDoE-hybrid modeling strategy. We also show how advanced monitoring strategies support the tracking of the deviations and how these methods can readily be developed from the iDoE data. It will be illustrated how the combination of the hybrid model with monitoring can directly be exploited for process control, thus naturally evolving the last step of the QbD roadmap.

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

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.

SC7: Predicting & Controlling Bioformulation Stability

Instructors: Kevin Mattison, PhD, Principal Scientist, Malvern Panalytical
Matthew Brown, PhD, Applications Manager – AMEC, Malvern Panalytical

Protein aggregation is recognized by regulatory agencies and the biopharmaceutical industry as a key quality attribute for biotherapeutic products. This course provides an introduction to the origins and consequences of aggregation in biotherapeutics, examines strategies for predicting and quantifying aggregation in biopharmaceutical formulation development, and provides deeper insights into the influence of formulation parameters and excipients on protein aggregation and formulation viscosity. It benefits scientists engaged in the development, production, analytical characterisation and approval of biotherapeutics, and anyone requiring a working knowledge of protein aggregation.

* The program is subject to change without notice, due to unforeseen reason.

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