Every particle matters

Particle identification and characterisation tools for biologics and cell and gene therapy, covering origins, analytical methods and troubleshooting.

November 29th, 2023

4pm (CET) / 10am (ET)

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OVERVIEW

Particles in the visible and subvisible size range can appear in (bio)pharmaceutical samples and drug products during all stages of development and even after market approval. The presence of particles can indicate an insufficient stability of the active pharmaceutical ingredient or issues with the production process and can negatively influence the safety and efficacy of the medicine. Particle identification is therefore a crucial step in the development and troubleshooting of biopharmaceuticals.

In this webinar Dr. Tim Menzen, Chief Technology Officer and Dr. Daniel Demminger, Expert Scientist at Coriolis Pharma will talk about tools and methods for particle identification and characterization in biologics and gene and cell therapy drug products.

Addressed Challenges

01Identifying particles with complex chemistries and diverse origins, requiring a range of instruments to characterise their nature and uncover their source.

02Distinguishing between product-related particulate APIs such as LNPs and viruses, and unwanted particles arising from instability or process contamination.

03Conducting particle identification under time-critical conditions when unexpected visible particles trigger urgent investigations with high-stakes quality decisions.

WHAT YOU WILL LEARN

01Understand what types of particles can be present in biologic or gene and cell therapy products and what their presence can indicate about product quality.

02Learn what needs to be characterised in particle identification programmes and which analytical methods are appropriate for each particle type and situation.

03Discover where particle identification adds value in drug product development and troubleshooting, from early development through to post-approval investigations.

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SPEAKERS

Dr. Tim Menzen

Chief Technology Officer at Coriolis Pharma

Dr. Tim Menzen is the Chief Technology Officer (CTO) of Coriolis Pharma. He is a pharmacist by training and received his PhD from the Ludwig-Maximilians-Universität (LMU) in Munich, Germany. Dr. Menzen joined Coriolis Pharma in 2014 and is responsible for Coriolis' internal research projects and scientific relations, including collaborations with industry and academic partners. He has co-authored more than 30 publications in peer-reviewed journals.

Dr. Daniel Demminger

Expert Scientist at Coriolis Pharma

Dr. Daniel Demminger is expert scientist for particle identification at Coriolis Pharma. He is a biologist by training and specialized on virology and virus vector vaccines during his studies at the Julius Maximilians university, Würzburg, Germany and the Robert Koch Institute / Humboldt university, Berlin, Germany. Dr. Demminger joined Coriolis in 2020 as member of the ATMP group and has become the subject matter expert responsible for all particle identification-related topics, including analysis of biopharmaceuticals by IR-, X-ray-, and Raman-spectroscopy and electron microscopy techniques.

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