Laurent Ducry, Ph.D
Head, Bioconjugates R&D
||Sunday, January 8, 2017 | 5:00 - 8:00 pm: Production Challenges for Complex Biologics: Antibody-Drug Conjugates and Fusion Proteins
This course addresses the typical production issues encountered with complex biologics, namely fusion proteins, antibody-drug conjugates and bispecific antibodies. Experts elucidate the structure and nature of these biologics in order to understand and master their properties. Along with exploring manufacturing challenges, the course also reveals how to overcome these challenges with practical insights and advice.
Stefan R. Schmidt, Ph.D., MBA, Vice President, Rentschler Biotechnology
Gang Gary Chen, Ph.D., Head, ADC Technology, Levena BioPharma
Laurent Ducry, Ph.D., Head, Bioconjugates R&D, Lonza
Prof. Dr. Hanns-Christian Mahler
Head, Drug Product Services
||Tuesday, January 10, 2017 | 5:45-8:45 pm: Ensuring Accelerated and Successful Drug Product Development of Biologics: Integrated Formulation Development, Process and Packaging Design
Suitable biotech drug product design is key to the success of patient treatment. Formulation, manufacturing process and primary packaging are integral components of the drug product. In addition, a focus on management of the interface of drug substance to drug product is essential for efficient and successful development. This short course is designed to discuss strategies on how to approach an appropriate design for a target product profile, formulation, primary packaging and manufacturing process. Hot topics in drug product development, including particulates, aggregates, container closure integrity, surfactant stability and low endotoxin recovery, will be further discussed.
Lonza’s Advanced Automated Downstream Development Platform
made significant investment in High-throughput robotics, spanning from early
cell line selection to a full downstream purification train and associated
analytics. We are using the High-throughput Lonza platform to develop flexible,
adaptable processes that can serve a wider range of diverse products. We will
showcase our automated downstream tools used for buffer stability screening for
early indication of product quality risks, our future work on excipient
screening for proactive stability checking of niche biologics such as
intra-ocular products, and Mass spectrometry for the targeted removal of
specific Host Cell Protein impurities. Tangible advantages for our customers
and our vision for the future will be presented.
Hannah Shore, Downstream Process Scientist, Research & Technology, Lonza
Rita Tommasi, Ph.D., Associate Principal Scientist, Research & Technology, Lonza