Developability Assessment of Therapeutic Proteins – A Toolbox for Tackling Increasing Complexity

Early lead selection of biotherapeutics during preclinical development requires careful characterization of a variety of molecule properties to reduce the risk for encountering unexpected obstacles during technical development. The diversity and increasing complexity of new protein formats requires a change from former platform approaches often applied for antibodies, to project specific strategies. The developability assessment concept applied at Novartis combines information addressing various technical areas, such as expression, aggregation propensity, process fit, stability, physicochemical properties, etc. This integrated concept prior to lead selection provides a thorough, yet resource efficient approach to select suitable candidates.
Presented by Thorsten Lorenz, Team Head Developability Assessment Biologics at Novartis

Thorsten Lorenz studied Biochemistry at the University of Bochum in Germany. He performed his PhD work at the Max Planck Institute for Medical Research in Heidelberg and afterwards joined the Novartis Institute for BioMedical Research as a postdoctoral fellow. In 2011, he joined the Integrated Biologics Profiling (IBP) Unit at Novartis, setting up and leading a laboratory for biophysical characterization and pre-formulation assessment and got appointed Group Head in January 2016. In his current role as Head Developability Assessment, he responsible for the assessment of developability characteristics including molecular properties, downstream process and pre-formulation aspects, immunogenicity risk as well as in vivo fitness for all Biologics of the Novartis pipeline at the transition from Research to Development.
 
 
Understanding therapeutic protein stability and developability with Prometheus
In biopharmaceutical research, proteins are characterized in meticulous detail. Unsuitable candidates need to be deselected early, and only the most promising candidates are moved forward in development and into clinical testing. Understanding protein stability is an important piece of this puzzle.
The Prometheus system and its nanoDSF technology allow label-free analysis of thermal and chemical stability as well as aggregation of proteins. Its low sample requirements and broad concentration range make it an ideal tool for all steps of drug development.
This presentation will demonstrate
• the benefits of nanoDSF: label-free, highly precise and reproducible, easy-to-do measurements of any kind of protein, using just 10 µl of sample.
• how Prometheus generates unfolding temperatures (Tm and Tonset), critical denaturant concentrations (Cm), free folding energy (ΔG and ΔΔG), and aggregation results (Tagg).
• a variety of application examples.
 
Presented by Beate Kern, Product Manager at NanoTemper Technologies

Dr. Beate Kern studied Molecular Biotechnology at the Technical University of Munich and the Tokyo Institute of Technology. She went on to her PhD in Medical Microbiology at the Ludwig Maximilian University of Munich, where she studied Helicobacter pylori and its effects on human T-cells on a molecular level. Beate joined NanoTemper in 2015 as an Application Specialist in the Customer Support team. Currently, she is a Product Manager for the Prometheus and Tycho product lines.
 
 
 
Sponsored by NanoTemper Technologies

NanoTemper Technologies is deeply committed to the best customer experience. Central to this is a strong focus on enabling researchers to easily, efficiently, and accurately perform protein characterization. With a broad offering of systems, software and consumables for evaluating binding affinities, protein stability and quality, scientists in pharmaceutical, biotech or academic labs will find an optimized workflow, quality results and responsive customer support. Work with a deeply experienced and globally operating team, and realize the NanoTemper experience.