Next Frontier in Subvisible Particle Analysis: New Tools and Opportunities
07th May 2020 | 10:00 am PST, 1:00 pm EST, 6:00 pm GMT | Danny Chou, President and Founder at Compassion BioSolution, LLC and Mark Bumiller, Technology Manager at Particle Sizing Systems, an Entegris Company |BOOK FREE SEAT
In the past decade, we have witnessed the arrival of a large number of analytical technologies that are useful for characterizing sub-visible particles in protein therapeutics. Even with the diverse tools that are available today, there are still important gaps that have not been filled but yet have a significant role in our ability to fully analyze particles for either product characterization or formulation development purpose. The goal of this presentation is to highlight some of these gaps and share the opportunities that may be captured by new tools that are on the horizon. Finally, the speaker will elaborate on how simultaneous monitoring of sub-micron and micron-sized particles can assist biopharmaceutical formulation development and help fulfil current and future regulatory requirements
Presented by Danny Chou, President and Founder at Compassion BioSolution, LLC
Danny Chou is a patient-centered biopharmaceutical industry veteran with expertise in biopharmaceutical characterization, pre-formulation, formulation, and fill-finish operations. Dr Chou has over 15 years of experience developing formulations and analytical methods for protein pharmaceuticals and 20 years of combined clinical and R&D experience in the pharmaceutical industry. Dr Chou is a subject matter expert in the development and implementation of rational strategies for increasing protein stability during processing, storage, and delivery in both liquid and solid state. Dr Chou also has extensive experience managing research and manufacturing outsourcing both as a client as well as a contract research service provider.
Followed by a Industry Perspective presented by Mark Bumiller, Technology Manager at Particle Sizing Systems, an Entegris Company
Mark has worked in the field of particle size analysis for over thirty-five years. Positions held include Product Manager at Hiac Royco (5 years), Technical Support Manager and Vice President of Business Development at Malvern Instruments (17 years), Vice President of Particle Products at Horiba (6 years) and now Technology Manager at Entegris Particle Sizing (6 years). He has served as a member of the expert committee for USP 788, the executive committee of the International Fine Particle Research Institute (IFPRI) and the executive committee of Particle Technology Forum of the American Institute of Chemical Engineers. Mark is an active member of Technical Committee 24 within ISO helping to write standards for particle size and zeta potential analysis. His B.S. in chemical engineering was earned at Carnegie Mellon University in Pittsburgh, PA.
Sponsored by Entegris
Entegris, Inc. (NASDAQ: ENTG), purchased Particle Sizing Systems, LLC in Jan 2018. The Entegris Particle Sizing Business manufactures a range of particle characterization instrumentation for both the laboratory and online monitoring.
The AccuSizerTM line of instruments are based on the principle of single particle optical sizing (SPOS). The AccuSizer system is used for USP <788>, <787>, <789>, and <729> subvisible particulate matter testing. The LE400 sensor measures from 0.5 – 400 µm and the FX Nano sensor extends the dynamic range down to 150 nm. Unique capabilities include industry leading wide dynamic range, 1024 size channels, full USP calculation automation and reporting, an autosampler for high throughput and a micro plate analyzer. Combining the highest specification technology with advanced software and automation options make these the most advanced instruments available for USP particle testing.
ABOUT ENTEGRIS Entegris is a leader in specialty chemicals and advanced materials solutions for the microelectronics industry and life science industries. Entegris is ISO 9001 certified and has manufacturing, customer service and/or research facilities in the United States, China, France, Germany, Israel, Japan, Malaysia, Singapore, South Korea and Taiwan.