Developability Assessment and Early Formulation Studies for Biologics

Candidate selection, biophysical characterisation and pre-formulation screening to reduce late stage failures and build a strong data foundation.
February 27th, 2025
4pm (CET) / 10am (ET)
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OVERVIEW

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

01Selecting candidates with poor biophysical properties risks unforeseen delays and costly failures before the programme reaches the clinic. 
02Translating preclinical formulations into stable, high-concentration forms suitable for human use is often underestimated and resource-intensive. 
03Linking molecule-specific data to the target product profile and development goals in a holistic and phase-appropriate way throughout early development. 

WHAT YOU WILL LEARN

01Learn how to avoid costly late-stage drug development failures through early-stage risk identification and systematic biophysical characterisation. 
02Build a strong early development data foundation through comprehensive biophysical characterisation and benchmarking against commercial antibodies. 
03Explore novel innovative methods for assessing the biophysical properties of antibodies and how they improve candidate selection decision-makin
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SPEAKERS
Developability Assessment Webinar
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.
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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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