Balancing the demands of product quality, process productivity and scalability remain the key challenges for professionals involved in upstream process development. This course will address these core issues for both mammalian and microbial products.
Starting with cell line development, the course will move on to focus on media selection, screening, initial upstream process development and quality concerns to help you in laying the foundations for a success and productive process. On day two, you will explore upstream equipment in-depth and start to consider process characterisation, performance validation and scale up. You will also discuss the needs of the downstream process, how collaboration between USP and DSP teams can be facilitated and how process transfer can be addressed.
Taught by Margit Holzer, an experienced bioprocess development expert, this course will deliver a wealth of examples and discussion to help you in your learning.
This course will be of interest to professionals involved in upstream process development, including:
Margit is a specialist in process, product and analytical methods development for preclinical and clinical production phases as well as for commercial supply.
After completing her doctorate in Vienna, Margit began working at Boehringer Ingelheim, eventually establishing and becoming the head of the new division of manufacturing sciences. She moved on to become the Quality Director and later on the Technology, R&D and Innovation Director for NOVASEP in France, before setting up her own consultancy. She now assists clients in the evaluation, optimization and development of processes, analytics and technologies including innovative ones for Up & Downstream processing and Formulation. She has 25 years’ of experience in the industry and has worked on more than 50 different products.