Every particle matters

November 29th, 2023 - 4pm (CET) / 10am (ET)

Every particle matters

November 29th, 2023 - 4pm (CET) / 10am (ET)

Identify visible and subvisible particles in your biologic and gene and cell therapy drug product

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

Various chemistries and origins of particles: Particles in biopharmaceuticals may originate for instance from the active pharmaceutical ingredient, excipients, degradation products, process-related impurities, and other extrinsic sources. Therefore, particles can exhibit complex chemistries. A set of instruments is usually required to identify and understand the nature of the particles and can thus uncover their source.
Novel modalities and particulate active pharmaceutical ingredients: Instability of the active pharmaceutical ingredient may result in aggregation and formation of unwanted (visible) particles. On the other hand, lipid nanoparticles, viruses and cells are particulate drug products. Dissecting product-related, process-related, and other particles is a key question.
Demanding timelines and high-staked decisions: Unexpected observations of (visible) particles often result in time-critical investigations because decisions about product quality will be based on these results. Thus, particle identification in a timely manner often plays a crucial role in assessing the associated risks.

What You Will Learn

What type of particles can be present in a biologic or gene & cell therapy product?
What needs to be characterized and how?
Where can particle identification provide added value to your drug product development or troubleshooting?

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.

Contact us

First Name

Last Name

By registering your details, you agree to our Privacy Policy and Terms & Conditions.

By ticking this box, you consent to receiving communications from Ypsomed and S3 related to this topic and other products or services within their portfolio

<span>By ticking this box, you agree to the privacy policies of <a href=”https://www.coriolis-pharma.com/data-privacy/” style=”color:white; text-decoration: underline;” target=”_blank”>Coriolis Pharma</a> and <a href=”/wp-content/uploads/2023/08/Livestorm-privacy-policy-en.pdf” style=”color:white; text-decoration: underline;” target=”_blank”>Livestorm</a>, consenting to receiving communications related to this topic and other products or services within their portfolio</span>

Dark