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.
This webinar will address the following challenges:
1. 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.
2. 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.
3. 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.
Speakers
Dr. Tim Menzen
Chief Technology Officer at Coriolis Pharma
Dr. Daniel Demminger
Expert Scientist at Coriolis Pharma
Learning objectives:
- 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?
