Speaker Bio

Duncan Low is a consultant providing technical services in raw materials management and risk management to both manufacturers and suppliers in the biopharmaceutical industry. He is an active member of several industry groups and scientific advisory boards, including the ASTM E55 Executive Committee developing consensus standards for Manufacture of Pharmaceutical Products, the ISPE Executive Committee for PAT, the Biophorum Operations Group, and has also been a significant contributor to the PDA Task Group for Single Use Systems and the USP’s Committee of Experts. He was co-chair of the 2009 IFPAC Conference. His broad experience includes his role as a Scientific Executive Director at Amgen (2003 – 2017), where he led the Raw Materials Global Network and Materials Science teams. Prior to joining Amgen he held VP positions at Millipore and Pharmacia Biotech. He has an M.A. in biochemistry from the University of Cambridge and a Ph.D. in microbiology from the University of Glasgow.

Abstract

As part of a Quality Control continuous improvement campaign, high concentration monoclonal antibody methods originally using traditional ultraviolet spectroscopy (UV), were evaluated against recently developed slope spectroscopy methods utilizing SoloVPE™.   The comparison studies between methods yielded higher accuracy and precision of concentration measurements for the SoloVPE™, while also reducing sample preparation time and improving method efficiency. 

Speaker Bio

Matthew Nowak is currently a Biological Researcher at Teva Pharmaceuticals USA, West Chester. He brings over 10 years of Quality Control GxP experience in biochemical and analytical applications, specializing in separations chromatography and UV analysis, and currently as coordinator for laboratory inventory management system (LIMS) software applications. Matt received his Bachelor of Science degree in Biology from Bucknell University, and Master of Science degree in Cell and Molecular Biology from Penn State College of Medicine. 

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

Mr. Bianchi is currently the Field Applications Specialist for Repligen downstream TFF products. He brings over 20 years of experience in process filtration and separation with a significant portion of that time focused on Tangential Flow Filtration applications utilizing flat sheet cassettes and hollow fiber modules. Mr. Bianchi has held various technical positions supporting Pall Corporation, Spectrum Laboratories, FloDesign Sonics and TangenX™. He holds a Bachelor of Science degree in Chemistry from Worcester Polytechnic Institute.

Abstract

As with any other biological based production process, batch-to-batch variability during rAAV production using baculovirus/Sf9 requires careful control and monitoring. Asa critical raw material, Baculovirus inoculum exerts a strong impact on process yield and/or product quality. Each baculovirus bank requires extensive analytical characterization and production parameters are often re-optimized for each bank, adding manufacturing time and cost. Executing multiple large scale rAAV production runs from a single inoculum would create significant manufacturing value.

Voyager Therapeutics’ has advanced a scalable and robust high cell density perfusion baculovirus/Sf9 platform to manufacture Baculovirus Infected Insect Cells (BIICs) for use as virus inoculum banks. An Improved flow system promotes high cell density and enables media exchange prior to BIIC cell cryopreservation. This work demonstrates the strength of the Voyager Therapeutics baculovirus/Sf9 platform, its potential to enable the commercial manufacturing of product candidates and its promise as a robust supply technology for gene therapy patients.

Speaker Bio

Krishanu is an Engineer with the technical operations group at Voyager Therapeutics where he is working on developing the next generation manufacturing platform for gene therapy vectors. He brings over 6 years of experience in upstream process development, including his work at Alexion where he was a member of Global Product Development, focusing on both early and late stage upstream development. Additionally, Krishanu spent time at Alexion as a CMC project manager co-op, gaining his Six-Sigma yellow belt training and facilitating cross group interactions to move early stage projects forward.  Prior to being at Alexion he worked at Florida Biologix in Alachua, FL as part of their Upstream Process Development Group for AAV MFG. Krishanu holds an MS in Biomedical Engineering from UF and a BE in Biotechnology from Netaji Subhas Institute of Technology

Abstract

A reduced scale comparative evaluation of different Protein A capture resins was performed. Dynamic binding capacity (DBC) was measured across a range of flow rates in order to model productivity in various operational modes. Resin lifetime was estimated by measuring DBC after timed exposure to sodium hydroxide. Results of the analysis were used to assess process operating costs for each resin type.

Speaker Bio

Paul has 30 years of experience in biologics processes, both in process development and large scale manufacturing. In his current role he serves as a purification development lead for a vaccine in late development at Janssen. Paul leads the DSP sub-team for Janssen’s Parenteral Center for Innovation, a multidisciplinary team charged with evaluating new technologies and applying them to large molecule purification processes. Paul developed the Gamma Distribution Transition Analysis method and drove implementation for use in measuring column.

Abstract

Applications of OPUS^® columns for downstream processes will be discussed. Use of OPUS^® ValiChrom columns for scale down studies, including viral clearance and process characterization, will be discussed and scale down model results will be compared to manufacturing data using OPUS^® columns.

Speaker Bio

Leslie received her Ph.D. in Molecular Biophysics and Biochemistry from Yale University prior to joining KBI Biopharma. During her tenure at KBI, she has been involved in the development, transfer, scale up and characterization of downstream processes. This includes the maturation of the KBI platform for mAbs and the establishment of a vaccine glycoprotein platform downstream process. Additionally, her work characterizing mixed-mode resins has led to frequent incorporation of these resins within processes with reduced development time and increased impurity removal. While at KBI she has been involved with over 35 biotherapeutics including monoclonal antibodies, Fc fusions, biosimilar, vaccine glycoproteins, enzymes and novel recombinant proteins. 

Abstract

Perfusion processes can achieve high cell densities (>50e6/mL) and consequently high productivity with the caveat that cell specific productivity can decrease during steady state perfusion with constant media composition. A strategy of feed adjustment over time that meets the needs of the cells at different stages of cell culture and results in improved productivity will be presented.

Speaker Bio

Peter Amaya received his Bachelor’s in Chemical Engineering from the University of Dayton and obtained his M.S. and PhD at the Ohio State University. While at Ohio State he characterized rare cells circulating in the blood of metastatic cancer patients to determine drug efficacy. Additionally, he was involved in the process development for manufacturing of endogenously produced extracellular vesicles from HEK293 cells for cancer treatment. He has been with MedImmune/AstraZeneca since 2017 as a process development scientist building next generation mammalian cell culture processes for manufacture of in-vivo biologics. 

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.

Speaker Bio

Shelly Parra has over 20 years of experience in biotherapeutic process development, scale-up, technology transfer, manufacturing, and validation. She is currently the head of the global Field Applications team at Repligen and works with customers optimizing and scaling both upstream and downstream unit operations.  Prior to Repligen, Parra was employed at Thermo Fisher Scientific, Amgen, Transkaryotic Therapies, and BASF Bioresearch. She holds BS and MS degrees in Biotechnology from Worcester Polytechnic Institute in Massachusetts.

Abstract

High Productivity Harvest (HPH) is a novel application developed by Repligen that enables you to harvest a fed batch bioreactor in a fully sterile manner while eliminating both centrifugation and depth filtration. A 0.2µm filtered, closed system and single step process using the XCell™ ATF System, HPH can significantly increase yields above industry standards and generate a sterile clarified batch harvest ready for either batch or continuous chromatography. This webinar will demonstrate how HPH works, present initial results of up to a 2-fold increase in protein production, and how you can apply HPH specific to your product need or facility design.  

Speaker Bio

John joined Repligen during 2014 as part of the acquisition of Refine Technology where he was Vice President. He has developed and worked with different upstream technologies and, most recently, has propelled the XCell™ ATF System to become the dominant industry technology in continuous culture. Previously, he has founded or co-founded multiple companies in several countries in industries from newspapers to bioprocessing. John advises and speaks on small business coaching and entrepreneurship. John is a regular international speaker on bioprocessing. He is the editor of two editions of a book introducing Continuous Bioprocessing.