Advances in Bioprocessing Industry case studies on single-use, flexible and continuous bioprocessing

Jean Bender is the Senior Director of the BioProcess Engineering department at MedImmune. The BPE department has three main functions:  an R&D pilot plant team for material generation and process scale-up assessment; a technology team responsible for transferring processes from development to clinical and commercial manufacturing and an engineering team focused on evaluation and implementation of novel technologies.  Prior to joining MedImmune in 2011, Jean worked for 19 years within the purification process development and process engineering groups at Genentech. She holds a BS and MS in Chemical Engineering.

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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. 

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. 

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.

Before joining Repligen in 2015, Christine Gebski was Head of the POROS® Business Unit within the Bioproduction Division of Applied Biosystems/LIFE Technologies/Thermo Fisher Scientific, working with purification products, including POROS® and CaptureSelect®  chromatography resins.  She managed Global Process Chromatography Applications for ten years, developing collateral and providing technical support, supporting new product development and manufacturing process improvement efforts. She also managed R&D, developing and commercializing three new chromatography resins. Before joining LIFE Technologies, Ms. Gebski was a Process Development Scientist for 15 years in the biotechnology industry, with roles in both development and engineering functions, including developing, scaling, transferring and validating downstream purification processes.  She received a B.S. in Biology from the University of Vermont and a M.S. in Biotechnology from the University of Massachusetts at Lowell.

Shawn Barrett is Associate Scientific Director of USP in the Continuous Manufacturing Skill Center at Sanofi Genzyme in Framingham, MA.  He has more than 20 years of experience at various organizations in the biopharmaceutical and biotech industry, including Life Technologies BioProduction R&D, Centocor J&J R&D, Eli Lilly BioRTP, and NRC Biotechnology Research Institute.  His bioprocess expertise includes perfusion and fed-batch cell culture process development and scale-up, cell culture medium development, bioreactor and facility design, and process control. Shawn currently leads a team of scientists and engineers tasked with the optimization and intensification of a perfusion platform for the enablement of integrated continuous manufacturing of protein therapeutics.  He received his Bachelors of Applied Science in Chemical Engineering from the University of Waterloo in 1994.

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.

Jesse Milling is currently Scientist II with bluebird bio at the Cambridge, MA facility.  Before joining bluebird, Jesse was an integral member of the Cell Culture Process Development Unit at Eleven Biotherepeutics. Jesse started his career in the Cell Culture Process Development and Manufacturing team at Acceleron Pharma. Jesse received his Bachelors of Science in Biology from St. Anselm College and a Master of Science in Biology from Tufts University.

Dr. Kathleen Mihlbachler is currently the LPT Global Process Separations Director leading the verification of chromatographic technologies and development of new approaches to optimizing chromatographic separations. She has worked for more than 15 years in the area of process chromatography, Dr. Mihlbachler supported the technical transfer of process chromatographic technology from Bayer Technology Services (BTS) and ChromaCon AG (multi-column chromatography) to LEWA and presently acts a technical consultant on leading edge customer projects. Prior to this Dr. Mihlbachler worked at different levels as Sr. Researcher in the pharmaceutical industry at BMS, Eli Lilly, and Pfizer. She was involved in the development, scale-up and manufacturing of purification/separation processes for chiral and non-chiral compounds, peptides and proteins, in particular to implement continuous processes. From 2011-2013 Dr. Mihlbachler taught undergraduate courses for chemical and biomedical students as a Sr. University Lecturer in the Department of Chemical, Biological, and Pharmaceutical Engineering at New Jersey Institute of Technology. Starting in 2014 Dr. Mihlbachler holds a Director position at the AICHE’s Separation Division. She is also a member of the Scientific Committee of the International Symposium on Preparative Chromatography since 2007 and since 2010 she has chaired the Poster Award Committee in addition to co-instructing workshops on “Preparative chromatography of pharmaceutical intermediate and API” at their annual symposium. Dr. Mihlbachler authored two book chapters on chromatography and she published her research results in numerous peer reviewed articles and external presentations at international meetings.