Developability of complex biologics: From Bioprocessing to Formulation

FrontImage_Biotherapeutics_II

The translation of candidate biotherapeutics into successful drugs ultimately depends on their efficacy, safety and availability to a large number of patients. It is therefore crucial to develop biologics that exhibit stability during large-scale production, storage and delivery. These “developability” and delivery problems are challenged by the complexity of biotherapeutics and the large number of stresses to which they are potentially exposed, and require the simultaneous optimization of a large number of biophysical properties.
We develop theoretical modeling approaches and innovative analytical methods, largely based on microfluidic technology, to develop safe and reproducible biologics, as well as innovative strategies for their delivery. Overall, the goal of our activities is to accelerate R&D timelines, eventually leading to safer and more effective drugs.

Contacts:

Antibodies: Isabel

Extracellular vesicles: Jonathan, Roberto

Key publications

external page C. Paganini et al., "High‐Yield Separation of Extracellular Vesicles Using Programmable Zwitterionic Coacervates", Small, 2022.

external page H. Narayanan et al., "Machine Learning for Biologics: opportunities for protein engineering, developability, and formulation", Trends in Pharm. Sci., 2021.

external page H. Narayanan et al., "Design of Biopharmaceutical Formulations Accelerated by Machine Learning", Mol. Pharm., 2021.

external page C. Paganini et al., "Scalable Production and Isolation of Extracellular Vesicles: Available Sources and Lessons from Current Industrial Bioprocesses", Biotechnology Journal, 2019.

 

 

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