Ken Hallenbeck, Scientist - Affinity Resins
The first and only NaOH-cleanable affinity resins for AAV2, AAV8 and AAV9 have been developed using a breakthrough development platform based on unprecedented ligand diversity. Performance metrics for capacity, yield and purity meet or exceed existing AAV resins while also withstanding more than 20 CIP cycles with 0.5 M NaOH. Off-the-shelf resin availability pre-packed in OPUS® Columns, as well as loose resin, enables streamlined implementation. The technical basis of the development platform and example data will be discussed.
Scientist - Affinity Resins
Dr. Hallenbeck, based in Lebanon, NH, is a Scientist at Avitide, a Repligen Company. In his current role he is focused on discovering novel peptide and protein ligands for use in first-in-class affinity chromatography resins. He joined Avitide in 2021, bringing expertise in structural and molecular biology from his former roles.
Ken received his PhD from the University of California, San Francisco studying protein-protein interactions and small molecule drug discovery, work which led to the founding of a VC-funded oncology startup that remains active today. He then worked at Genentech where he combined breakthroughs in laboratory robotics and directed evolution to explore the potential of new drug modalities such as peptide macrocycles.
Simon Fogarty, Head of Application Enablement, Tecan
Tim Schroeder, Director, Product Management - OPUS® Columns
Fast process development and time to market is crucial for the success of biopharmaceuticals, but often remains a time consuming task due to absence of screening technologies or purification strategies in particular for new biologic modalities in Gene Therapy.
This outline describes the advanced and fully automated purification development and optimization for an AAV vector with OPUS® RoboColumns® and Tecan’s Fluent™ robotic workstation.
Head of Applications Enablement, Tecan
Simon has a broad background in drug discovery automation covering all areas from assay development to design of automation systems. He is enthusiastic about the life sciences and constantly strives to provide practical working solutions to researchers. After working in both pharma/biotech and life science instrumentation sectors for a number of years he joined Tecan in 2008. At Tecan, Simon is Head of Applications Enablement in the USA.
Director, Product Management, OPUS® Columns
Based in Ravensburg, Germany, Tim Schroeder manages the OPUS® portfolio of pre-packed chromatography columns for process development. His work on lab scale resin column packing started during his diploma thesis at the Research Center in Jülich, Germany, which culminated in a US patent. Before Repligen acquired Atoll GmbH in 2016, Tim was Head of Production at Atoll GmbH and was involved in the development and production of MediaScout chromatography columns and the commercial launch of OPUS® RoboColumn® Columns. Tim obtained a Degree in Dipl.Ing. from the University of Applied Sciences Aachen, majoring in Biotechnology.
Adam Nelson, Product Manager, OPUS® Columns
Product Manager, Repligen
Adam Nelson has worked at Repligen for over 12 years in various roles within the Manufacturing, Engineering, and Product Management departments. Over this period, Adam has been a key contributor to the development and growth of the OPUS® Pre-Packed Chromatography Column product line. Early in his career, he developed and optimized the chromatography column production process which now produces > 3,000 columns per year in the range of 2.5-80cm internal diameter. Prior to joining Repligen, Adam earned a B.S. degree in Chemical Engineering from University of Massachusetts Amherst. Currently, Adam is the Chromatography Product Manager supporting new product launch, marketing collateral creation, and technical inquiries as the OPUS® subject matter expert.
Steven Cates, Sr. R&D Director and Madis Unt, Sr. Director and Site Lead - Artesyn
Newly designed Artesyn Chromatography Systems from Repligen execute processes with improved yield, reproducibility, and operational simplicity. Over-molded tubing connections eliminate the use of hose barbs and zip ties, which are prone to leaking. Synergistic multi-valve manifolds create a streamlined liquid path without small crevices that typically cause carry-over between buffers. Batch change-overs can be made in under 30 minutes with no tools. The positive impact on process yield and facility output will be discussed.
Sr. R&D Director
Steven Cates is the Sr. R&D Director at Artesyn, A Repligen Company. He brings more than 30 years of biopharmaceuticals industry experience to the table, most of which has been focused on the design and manufacturing of systems for bioprocessing. Steven started his career as an Engineering Services Manager at Sartorius Corporation leading the engineering operations for process filtration and analytical equipment. He then progressed to Systems Engineering Management specializing specifically on the design and fabrication of custom engineered bioprocessing systems. Steven further advanced his expertise on custom engineered systems as the Vice President of Engineering, Systems and Operations at AlphaBio. A founding member at Artesyn Biosolutions, he oversees the global design and development of single-use bioprocess systems from R&D and process development down to manufacturing and implementation. Steven has a MS in Molecular Biology from Stanford University.
Sr. Director & Site Lead
Madis Unt is Sr. Director & Site Lead for Artesyn, A Repligen Company. Madis started his career back in 2008, working as a Project Manager at Pharmadule building prefabricated modular pharmaceutical and biopharmaceutical facilities and process skids. Throughout the years he ran multiple larger and smaller scale commercial projects for various global customers. In 2016, ARTeSYN Biosolutions Estonia was established and Madis started building up operations and the team to design, manufacture and build single-use systems and components in Europe. Today, Madis still oversees the company's operations in Estonia as a General Manager and is also heavily involved in new product development by materializing ideas from R&D and carrying new product designs from concept and prototype stage to serial manufacturing. Madis has a MS in Industrial Engineering & Management from Tallinn University of Technology.
Frank Agbogbo, Vice President of Process Development, Forge Biologics
Kathleen Milbachler, Director of Process Engineering, Systems
The growing complexity of new modalities is raising the expectations of single-use chromatography technology. The traditional systems still in use however present dozens of built-in challenges all along the flow path. Decades of drive, development, and attention to every detail allowed us to turn these challenges into higher recovery, maintained bioactivity and mitigated risk. This talk takes you from a system in the back of a sprinter van into the facilities of the future. Unique technologies of the systems platform that support higher the increased process efficiency will be discussed in detail. Case studies on the application of these technologies to increasing AAV recovery and analyzing graadient control will also be addressed.
Vice President of Process Development, Forge Biologics
Frank Agbogbo is the Vice President of Process Development at Forge Biologics. He has been at Forge Biologics since August 2021 and is leading the process development for rAAV production. Prior to Forge Biologics, Frank was the Senior Director of Process Development at Cytovance Biologics with oversight responsibilities over development, tech transfer and support of scale-up activities. He was at Cytovance for over 7 years where he took increasing responsibilities from Director of Fermentation to Director of Process Development with oversight responsibilities over the Upstream and Downstream teams. Prior to Cytovance, Frank was the Application Technology Manager at Mascoma Corporation where he contributed to the launch of two commercial products. Prior to Mascoma, Frank was a Principal Scientist at ICM, Inc. and a Scientist at Novozymes. His experience includes process development, Design of Experiments (DoE), process optimization, process characterization and scale-up from R&D to manufacturing (cGMP and non-cGMP). Frank holds a Bachelor of Science in Chemical Engineering from Kwame Nkrumah University of Science and Technology, PhD in Chemical Engineering from Texas A&M University, College Station, TX and MBA with a certificate in Entrepreneurship from the Price College of Business, Oklahoma University, OK.
Kathleen Mihlbachler, PhD
Director Process of Engineering, Systems
Dr. Mihlbachler is a global technology leader in process chromatography, especially its continuous operation. With over 25 years’ experiences in the field, she has comprehensive knowledge about the pharmaceutical manufacturing of biologics and API. In her current position as Director of Process Engineering, she is focus on standardization and commercialization of the Repligen SU chromatography platform technology. Prior to joining Repligen, Dr. Mihlbachler was the principal architect of the YMC Twin platform by successfully leading the tech transfer of the ChromaCon’s technology to the process scale.
Dr. Mihlbachler worked for over 10 years in different Sr. Research positions 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, oligonucleotides, and proteins, including the implementation of innovative continuous processes. From 2011 to 2013, Dr. Mihlbachler also taught undergraduate courses in chemical and biomedical engineering at New Jersey Institute of Technology.
Derek Masser, Director, Fluid Management
Derek Masser has worked with single-use products in the Biotech and Pharmaceutical industries for 16 years. In that time, Derek has been a key contributor in the development and positioning of single-use bioprocess containers, sterile sampling systems, and single-use mixing systems. Throughout this effort, he has worked with teams around the world to design and deploy these unique products. Derek earned a B.S. in Business and Marketing from Penn State University. Currently, Derek is the Director of Fluid Management for Repligen.