The Common Road to Quality for Single Use Materials
21st April 2021 | 10:00am PST | Trishna Ray-Chaudhuri, PhD, Principal Technical Manager, Genentech- A Member of the Roche Group and Kevin Mullen, Sr. Product Manager, Single-Use Systems at Thermo Fisher Scientific |BOOK FREE SEAT FOR THIS WEBINAR
Single use system (SUS) quality needs are similar to requirements used for their stainless steels analogs. As an example, a user implementing a stainless-steel system must oversee the design completely and is responsible for process validation. Similarly, when a user retrofits a stainless-steel system, the user and SUS supplier partner to demonstrate equivalent levels of quality and process control. The supplier is responsible for manufacture, cleanliness and sterilization while the end-user remains accountable to the regulatory agency for the quality of the process and final drug product.
This webinar will review the current best practices for implementation of single use systems with regard to quality, specifications, and user requirements. The content was created in partnership with companies and suppliers across the industry and represents the current perspectives for best practices.
Presented by Trishna Ray-Chaudhuri, PhD, Principal Technical Manager, Genentech- A Member of the Roche Group
Trishna Ray-Chaudhuri is Principal Technical Manager in Global Materials Quality at Genentech (Member of the Roche group) in South San Francisco, California. She currently oversees projects for the introduction and implementation of direct materials including single use systems. In her initial role at Genentech, she was responsible for specifications to support single use system performance and reliability as well as ensuring global supplier requirements were aligned across sites.
Trishna co-led the BioPhorum workstream on Supplier Based Reliability for single use systems. The team successfully identified industry best practices for bioprocess container handling and root cause investigation of leaks. In addition, Trishna was a key driver of the BioPhorum User Requirements Specifications (URS) guidance for single use systems. Both BioPhorum projects are being adopted by the industry.
Before joining Roche, Trishna was Technical Manager at Sartorius-Stedim, a major supplier of single use systems. She also worked at Monsanto Plastics which was later acquired by Bayer. Trishna has a PhD and MS in Polymer Engineering from the University of Tennessee and a BS in Chemical Engineering from Rutgers College of Engineering.
Followed by Kevin Mullen, Sr. Product Manager, Single-Use Systems at Thermo Fisher Scientific
Kevin Mullen is a Sr. Product Manger at Thermo Fisher Scientific, based in Logan Utah. For the past 2.5 years, Kevin has been managing the Single-Use Bioreactors and Single-Use Fermentors portfolio. In his role, Kevin is working closely with the development team to enhance and better characterize the performance attributes of single-use hardware systems. Prior to joining Thermo Fisher, he spent 13 years as an engineer and product manager in the medical device industry. Kevin holds an M.S. degree and an MBA from Utah State University majoring in Biological Engineering and business respectively.
and Marcus Bayer, Market Segment Manager Single Use at Hamilton
Marcus Bayer is market segment manager for single use solutions at Hamilton Bonaduz AG, Switzerland. In this position he is responsible for the expansion of the sensor portfolio to the needs for the disposable sensor market. With over 20 years of experience in both the plastics as well as process engineering industries, Marcus is an expert on leveraging technologies for single use applications. Before he joined Hamilton Bonaduz AG in 2016, Marcus was responsible for the market and application development at EMS Chemie in Ems, Switzerland. He holds a degree in both plastic engineering and business and administration.
Sponsored by Thermo Fisher Scientific and Hamilton
About Thermo Fisher Scientific
Thermo Fisher Scientific supports developers and manufacturers of biological-based therapeutics and vaccines with a world-class product portfolio that spans the bioprocessing workflow from discovery through large-scale commercial production. Starting with production-grade raw materials and supply chain logistics, we provide solutions and services across the manufacturing value stream and through QC release of finished goods, including upstream cell culture, downstream purification, analytical and QC testing, end-to-end single-use technologies, and comprehensive measurement and control solutions.
Hamilton Company is a global enterprise with affiliates in Nevada, Massachusetts and Switzerland with local support around the world. Hamilton Company has focused on life sciences for over 60 years and has become an industry leader in the design and manufacture of liquid handling solutions, process analytics, robotics, and automated storage solutions. The Process Analytics group has focused on improving biopharmaceutical processes for over 30 years and produces process sensors for the in-line measurement of pH, optical dissolved oxygen (DO), viable cell density, optical density, oxidation-reduction potential (ORP), and conductivity. Hamilton PA has the most complete portfolio of process sensors for CPPs in the bioreactor. Hamilton Arc® products include intelligent sensors to increase the robustness of data and the richness of diagnostics. This intelligence also eliminates the need for traditional transmitters and moves the functionality to a smartphone, tablet, or PC. Arc sensors measure more reliably and save on cost by communicating directly with the process control system.