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Registration will begin at 9:00 a.m. Pre-registration is required to attend.
Peter Lynch joined WuXi AppTec in 2014 after graduating from Thomas Jefferson University with a MS Degree in Bioscience Technologies. As a member of the Process Development and Commercialization team, he is focused on design of experiments for downstream unit operations supporting internal projects and client programs to manufacture cellular and viral vector therapies.
Utilizing perfusion in cell culture production can enable improved productivity and molecule quality. The redevelopment of a microcarrier process to a suspension culture will be detailed.
Kory Blocker graduated with her PhD in Chemical Engineering from University of Delaware where she studied gene delivery methodologies. She subsequently went on to Tulane University as a Post-doctoral researcher and worked on genetic modifications to yeast and mammalian cells for applications in the biofuel and pharmaceutical industries. Following completion of the Post-Doc at Tulane University, she joined Patheon Biologics as a scientist working in Upstream Process Development.
With an innovative side port that allows for simple resin unpacking, OPUS® 45R and OPUS® 60R columns provide the ultimate flexibility in pre-packed column technology. Without compromising chromatographic performance or column cleanability, the new feature helps mitigate the risk of implementing pre-packed columns in cGMP settings, and allows for re-use of the unpacked resin for other purposes. Test results on chromatographic performance, bioburden testing, shipping tests and simple unpacking procedure will be presented.
Fletcher Malcom is a creative MBA graduate and biopharmaceutical industry professional, who spent his early career with Waters Corporation as a technical chromatography representative working with large pharmaceutical and biotechnology clients in the Eastern United States. Since leaving Waters, Fletcher has graduated with honors from Babson’s MBA program, and joined Repligen as a Product and Marketing Manager. In 2011 and 2012 Fletcher led all efforts to complete the development and commercialization of Repligen’s new platform of OPUS® pre-packed disposable columns. Currently Fletcher is Director of Product Management for Repligen's Downstream Technologies.
Implementation of single-use alternatives in tangential flow filtration (TFF), a critical step in concentration and diafiltration (buffer exchange), is becoming platform in downstream bioprocessing. Repligen TangenX™ SIUS™ Single-use Cassettes are the first purpose-built cassettes designed for tangential flow filtration. This presentation will demonstrate how deploying these innovative cassettes can help reduce filter cost by 80%, reduce labor costs by 50%, and reduce buffer and water usage by 75% when compared to traditional reusable cassettes.
Michael LaBreck is Director for Repligen TangenX™ TFF products at Repligen starting in December 2016. Before that, he supported the TangenX™ product line at NovaSep 2008- 2016. He has over 20 years experience with tangential flow filtration applications support in the biopharmaceutical industry. He has held various sales and applications engineering positions with Pall Corporation and GE Healthcare. Michael has a Bachelor of Science degree in Mechanical Engineering from Syracuse University.
This presentation focuses on a case study where a mammalian cell culture process producing mAb A was developed almost exclusively utilizing high-throughput (HT) technology. The study describes how HT systems such as microbioreactors for cell culture development and Repligen OPUS® Process Development columns driven by robotics for purification development were integrated to rapidly develop a robust production process that was then directly scaled-up for cell culture and purification steps to generate material for investigational new drug-enabling toxicology studies. Performance comparability across scales demonstrates the effectiveness of HT process development for accelerating the time to clinic.
Juan Cueva is currently a Downstream Process Development Scientist with Biogen at the Research Triangle Park (RTP) facility in North Carolina. He has over six years of experience collaborating with multidisciplinary teams in the biopharmaceutical industry incurring in areas such as technology transfer, bioprocess design, scale-up and optimization, and sensing and control of upstream and downstream unit operations. Lately, he has been involved with high throughput technologies to accelerate and improve process development efficiency ahead of clinical production. Juan obtained his Bachelor of Science degree from Escuela Politécnica del Ejército (ESPE) in Ecuador. Then, he was awarded a National Science Foundation Fellowship to complete his Master of Science degree in Biomanufacturing at the Golden Leaf Biomanufacturing Training and Education Center (BTEC), NC.
Light refreshments will be served.
There is no charge for attendance but registration is required. Seats are limited to end-users of bioprocessing tools and technologies.
Travel, accommodations, and incidental expenses are the responsibility of attendees. Lunch will be served.
Princeton Marriott at Forrestal
100 College Road East
Princeton, New Jersey 08540 USA