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Repligen Technical Seminar

Bioprocessing breakthroughs and

solutions that work

tuesday, September 3, 2019   |   Shanghai, China

Repligen technical seminars are unique opportunities to discuss with  key thought leaders and experts  the changing landscape of bioprocessing around the world. Industry case studies in process intensification, continuous processing and flexible facilities allow you to learn from adopters of transformative technologies, evaluate risk landscapes and set the standards for modern bioproduction.

In 2019, major technology breakthroughs will be introduced that signal market shifts in bioprocessing.

Locations include Shanghai, Washington, D.C., San Francisco, London and Geneva.

Click here to view past seminar agendas.

Intercontinental Shanghai Pudong - New Asia Ballroom
No. 777 Zhangyang Road
Pudong New Area: Shanghai, SH, 200120, Mainland China

AGenda

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More and more companies are looking for a CDMO partner to advance their molecule into Phase I clinical trials as quickly as possible. Patheon’s Quick to Clinic program can deliver released drug substance (IgG1 or IgG4) starting from DNA  in just 14 months. This is 6 months faster than most other standard timelines and includes a cell line documentation package, non-GMP drug substance for toxicology studies, released GMP drug substance for First-in-Human studies, viral clearance data and at least one month of stability data. Establishing platform raw materials and working closely with suppliers are key activities to enable the success of accelerated programs. Patheon can also work with customers to efficiently transfer an established process directly into a GMP manufacturing facility with minimal or no additional development. This flexible way of working can allow the customer to meet an unexpected increase in demand for the drug substance or to quickly access new global markets.

Speaker Bio

evan-shawHeadshot2019a.jpgAfter receiving a PhD in Analytical Chemistry from Texas A & M University, Evan spent four years at Genentech in the Downstream Process Development department in San Francisco, California. Here he was responsible for developing and transferring large scale commercial manufacturing processes for monoclonal antibodies and recombinant proteins from mammalian and bacterial cell cultures.  Evan then relocated to Sydney, Australia and started at Cephalon (now Teva) where he led the downstream development and outsourcing of manufacturing processes for clinical programs. Three years later Evan joined Patheon Biologics (now part of ThermoFisher Scientific) as the construction phase of the new GMP manufacturing facility in Brisbane Australia was being completed. At the early stages of site start up, Evan was responsible for identifying, procuring and validating the equipment required to get the facility operational. He also established standard procedures for a broad range of manufacturing operations, particularly those using single use systems. Since the successful start up of the new GMP facility, Evan has focused on building the process engineering, validation and tech transfer group and developing the key processes needed to move projects around the Patheon Bioloigics global drug substance manufacturing network.

Abstract

In response to customers challenged with bioburden-sensitive TFF processes, technology leading single-use TangenX™ TFF flat sheet cassettes are now available in closed and irradiated format.  Used in ultrafiltration and diafiltration, the new cassettes come pre-assembled and pre-tested, using the same proprietary membrane choices and multiple MWCOs as SIUS™ flat sheet cassettes.  This session will demonstrate how the new cassettes integrate easily into any process with faster turnaround time, improved productivity and lower risk of contamination.

Speaker Bio

Zhentao Sun.jpgMr. Sun is a Filed Application Scientist in Repligen’s downstream FAS group. He focusses on exploring new applications of TFF to meet multiple needs and new challenges for contemporary bioprocess. He has 10+ years’ experience working in process filtration, separation and purification for Pharmaceutical industry. Mr. Sun has served for Biotrand Inc, Pall Corporation and Spectrum Laboratories successively. He holds a doctor degree in Biomass Engineering from China Agriculture University and M.S. degree in Microbiology.

Abstract

An innovative ligand, NGL-Impact® A, developed by Repligen with Navigo through rigorous gene shuffling, screening and multimerization, is the basis of a new capture resin that rivals current industry standards. Partners in innovation, Repligen and Purolite used a proprietary jetting-based bead manufacturing process to develop the novel Protein A resin, Praesto® Jetted A50, that has been shown to deliver high capacity, caustic stability and bead uniformity. Potential economic benefits include decreased initial resin cost, extended resin lifetime, lower buffer usage and less operation time.

Speaker Bio

Purolite(HR)-0640-Chris.pngChris has 17 years biotechnology experience, having spent time with GE Healthcare, WAVE Bioreactors and Merck Millipore, advising clients on start-to-finish protein purification and MAb bioprocessing. At Purolite he leads the global commercial operations of the agarose division.

Speaker Bio

Dr. Shuyuan Yao received his Ph.D degree on Molecular&Medical Genetics from University of Toronto School of Medicine, accomplished postdoctoral research in stem biology at The Scripps Research Institute(TSRI) at San Diego, California. From 2006 to 2014, Dr. Yao had worked in Sangamo BioScience, StemGent Inc and Allen Institute for Brain Science, etc. In 2014, Dr. Yao moved back to China and worked at Vertex Pharmaceuticals R&D (Shanghai) Co., Ltd. Dr. Yao joined WuXi AppTec in Nov. 2014, from 2014-2016 Dr. Yao had served as Senior Director of Cell Therapy Research and headed Cell Therapy Research Department. From 2016 to 2018, Dr. Yao served as VP of Operations at JW Therapeutics Co., Ltd. leading the company’s R&D, manufacturing and operations. In May 2018, Dr. Yao served as WuXi AppTec VP of Operations & General Manager of WuXi ATU Co., Ltd. Dr. Yao has established and managed several start-up project and companies, has strong experiences on R&D, manufacturing, facility, team and project management.

Abstract

As a bioprocessing innovator with technology expertise in filtration, Repligen has developed a breakthrough clarification and harvest technology that can signal a paradigm shift in mAbs and Gene Therapy bioprocessing.  A result of continuous innovation at Repligen, the solution integrates advances in multiple disciplines, combining novel polymer technology, various filtration modes, hardware, systems and automated process management.  Potential benefits to productivity, product quality, yield and workflow efficiency will be discussed.

REGISTER NOW

 

There is no charge for attendance but registration is required. Seats are limited to end-users of bioprocessing tools and technologies. Travel, accomodations, and incidental expenses are the responsibility of attendees. Lunch will be served.

Questions? Email EVENTS@REPLIGEN.COM