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

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

Chris 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.

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

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.

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.