Subvisible Particle Identification & Characterisation by Multi-Technique Methods
23rd February 2017 | 2PM GMT | Dr. Jonas Hoeg Thygesen, Novo Nordisk Pharmatech. Followed by Colin Merrifield, ProteinSimple |WATCH FOR FREE
Observable foreign and particulate matter has for a long time been recognized as a critical quality attribute for production of injectable protein formulations. Recently, a focus shift towards these particles and even smaller particles (particulate matter or subvisible particles) has been seen from the pharmaceutical industry, academia and the different regulatory bodies. Two of the central documents in this context are:
1. The FDA Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products1 and
2. United States Pharmacopia Chapter <1787>
The first of these documents (from Aug 2014) “represents the Food and Drug Administration’s (FDA’s) current thinking on this topic”, and thereby explains the FDA’s concerns and expectations within the field of protein aggregates in biologics. The document calls, among other things, for analyses of protein aggregates, where “assessment should be made of the range and levels of subvisible particles (2–10 microns) present in therapeutic protein products”1. This leads to a natural need for development of new analytical methods for identification and characterisation of (subvisible) particles. The USP chapter <1787> gives guidance on how subvisible particles may be analysed. The USP <1787> thereby lists different methods for “enumration, characterization and when possible, identification” of the subvisible particles.
USP <1787> classifies the methods into methods for “Size and Distribution”, “Size and Morphology” and “Characterization”. Due to the traditional focus on counting observable foreign and particulate matter, the methods belonging to the first class are well established in many pharmaceutical QC laboratories as for instance described in USP <788>, <429> or Ph.Eur. 2.9.19, 2.9.31. This webinar will focus on the latter two classes, providing an insight into how some of these different analytical techniques may be combined to identify particles and particulate matter. The different technique’s strengths and weaknesses will be discussed, just as the synergistic effect that the combination of methods may offer will be highlighted.
Presented by Dr. Jonas Hoeg Thygesen
Dr. Jonas Hoeg Thygesen, Area Specialist at Novo Nordisk Pharmatech, performs research within microscopy, microanalyses and new analytical methods for particle identification. His main areas of expertise are spectroscopy, microanalysis and advanced data analysis (chemometrics). He holds a Ph.D. from University of Copenhagen within Process Analytical Technology (PAT). Dr. Thygesen is a Danish National, born in June 1983.
Sponsored by ProteinSimple
ProteinSimple, a division of Bio-Techne, is a life sciences company dedicated to providing epic tools to researchers who tackle the toughest problems in the world. Offering products that support everything from basic research to sophisticated drug development, ProteinSimple aims to facilitate the research needed to bring new science and better therapies to the world.
Presented by Colin Merrifield
Colin Merrifield is the Product Manager for Micro-Flow Imaging at ProteinSimple. He obtained his degree in Molecular and Cell Biology from the University of Connecticut. Before he began his obsession with aggregated proteins, he worked with solubilized ones as an assay developer for a startup in the greater Boston area. From immunoassay to particle analysis platforms he has spent a decade helping to bring novel tools and solutions to the life science industry.
Presentation Title: Micro-Flow Imaging as a Tool for Development and Risk Mitigation in the Pharmaceutical Industry
Presentation Summary: Particle analysis is a crucial area for the safety and success of pharmaceutical products and Micro-Flow Imaging is a centerpiece technology in the effort to more fully characterize the particles present in drug products. This talk will cover the concept of Micro-Flow Imaging and how its capabilities can help pharmaceutical companies better manage their product development for higher quality and safety. MFI provides critical insight, from formulation studies to safety testing and even bioprocessing.