Developability Assessment and Early Formulation Studies for Biologics

February 27th, 2025 – 4pm (CET) / 10am (ET)

Developability Assessment and Early Formulation Studies for Biologics

February 27th, 2025 – 4pm (CET) / 10am (ET)

A Focus on Science-Driven Risk Management and Development Optimization

Navigating the complexities of biologics development requires a science-driven approach to mitigate risks and streamline early drug development. This webinar explores best practices for identifying and selecting the most developable lead candidates, defining the formulation corridor through robust pre-formulation screening, and incorporating clinical in-use stability testing to derisk your strategy.

Led by Dr. Andrea Hawe, Chief Scientific Officer and Dr Kristian Le Vay, Expert Scientist at Coriolis Pharma, the session focuses on understanding critical biophysical properties to build a solid data foundation, reducing the risk of late-stage failures. Attendees will gain insights into aligning molecule-specific data with target product profiles and leveraging innovative methods to assess biophysical properties and benchmark against commercial antibodies.

Join us to optimize your biologics development process and accelerate progress toward clinical trials

Addressed Challenges

Candidate Selection: The selection of candidates with poor biophysical properties can result in unforeseen challenges, unpredictable delays, and costly failures on the path to the clinic.
Drug Formulation Issues: The successful translation of preclinical formulations into stable and high concentration forms suitable for human use is a key but often underestimated success factor, which may require unexpected development work if not addressed at an early stage.
Addressing Drug Product Formulation in a holistic way: Link the knowledge and generated data for your molecule to the target product profile and development goals.

Learning Objectives

Avoiding costly late-stage drug development failures through early risk mitigation
Building a strong data foundation during early development with comprehensive biophysical characterization and benchmarking against commercial antibodies
Introduction to novel innovative methods to better assess the biophysical properties of antibodies

Dr. Andrea Hawe

Chief Scientific Officer at Coriolis Pharma

Andrea Hawe is the Chief Scientific Officer at Coriolis. She is an expert in drug product development for biologics with a strong scientific background in protein formulation, surfactant and particle characterization, and lyophilization process technology. Andrea has published more than 40 peer-reviewed papers and book chapters. Andrea is a pharmacist with a PhD in Pharmaceutical Technology from the LMU Munich. After her PhD, she continued her career as a postdoctoral scientist at the Leiden Academic Center for Drug Research (LACDR) in Leiden (The Netherlands). She was awarded a Veni Fellowship (NWO, The Netherlands) to develop novel approaches for aggregate analysis. She joined Coriolis from the very beginning as a member of the founding team and has been supporting the company since 2008.

Dr Kristian Le Vay

Expert Scientist at Coriolis Pharma

Kristian Le Vay is an Expert Scientist at Coriolis, with a focus on novel methods for the developability assessment for biologics. He is a chemist by training with a diverse research background, encompassing the biophysical characterization of complex biomolecules, and the development of advanced therapeutics and drug delivery vectors. He completed his PhD at the Bristol Centre for Functional Nanomaterials (BCFN), University of Bristol, UK, where he developed a keen interest in biophysical method development. Following this, he studied nucleic acid condensation and stability as a postdoctoral scientist at the Max Planck Institute for Biochemistry, Munich, before joining Coriolis in 2022.

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