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 Donald Young, Sr. Product Manager at Thermo Fisher Scientific and Marcus Bayer, Market Segment Manager Single Use at Hamilton |WATCH FOR FREE
Single-use system (SUS) quality needs are similar to requirements used for their stainless steel 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 the 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, Ph.D., 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 Ph.D. and MS in Polymer Engineering from the University of Tennessee and a BS in Chemical Engineering from Rutgers College of Engineering.
Followed by Component Qualification, Supplier Qualification
SUT suppliers have implemented rigorous internal testing programs to help ensure that their products are fit-for-purpose and meet or exceed their customers’ expectations. This presentation discusses the critical assessments performed by 1 SUT product supplier during raw material selection and introduces the audience to a case study example.
Presented by Donald Young, Sr. Product Manager at Thermo Fisher Scientific
Donald Young is the Product Manager for BioProcess Containers, at Thermo Fisher’s BioProduction Division facility in Logan, Utah. He has a Bachelor of Arts degree in Biology and a Master of Science degree in Public Health. Don has 10 years of experience as a product manager. Don started his career as a laboratory technician specializing in cell culture and joined Thermo Fisher after working as a medical science liaison at Abbott Laboratories and Merck, Sharp, and Dohme for 12 years. Don’s management of BioProcess Containers entails participation on cross-functional teams that manage change control, pricing, supply chain, film portfolio, training, product customization, and component library maintenance.
and Quality Aspects for SU Components – Explained on the Example of Single-Use Sensors
Quality requirements from the end users in the single-use (SU) BioPharma industry are applicable to their whole supply chain. As a SU sensor supplier, Hamilton needs to consider the demands and special needs of a component used in a SU container from the very beginning of a sensor’s development. Hamilton’s OneFerm pH sensors have been developed specifically to meet such application needs and end user expectations, including high standards for quality by design and accuracy of the measurement. This also includes meeting all the needs of the integrators, such as certifications of post-sterilization and extended shelf-life characteristics.
This presentation will provide an overview of the development and certification process for Hamilton’s OneFerm and new SU Optical DO sensor.
Presented by Marcus Bayer, Market Segment Manager Single Use at Hamilton
Marcus Bayer is the 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 of 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.
About Hamilton
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 the cost by communicating directly with the process control system.