Bringing you the latest cutting-edge research and commentary in bioscience.

Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

Issue Vol 5 Issue 3

Editorial

Manufacturing of genetically modified autologous T cells: key considerations for process development

Spotlight Article

Editorial

Mamta Kalra & Ali Mohamed

Upstream Bioprocessing Update

The spectacular advancement of chimeric antigen receptor (CAR) T cells has given birth to several new biotech companies with rapidly growing pipelines of T-cell therapy products targeting various tumor antigens. For all these new players entering the field of genetically modified T cells, the manufacturing capability becomes one of the critical factors for success. Whether developed at a contract manufacturing organization (CMO) or in-house, a thorough know how of the manufacturing process is central to successful delivery of quality products. Here, we present currently available options for major steps, important considerations during optimization and challenges of process development for manufacturing of genetically modified autologous T cells.

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Commercial Insights

Cell & Gene Therapy Commercial Insight – March 2019

Commercial Insights

Mark Curtis & Richard Philipson

Upstream Bioprocessing Update

Providing a critical overview of the sector’s commercial developments – M&As, licensing agreements & collaborations, financial results, IPOs and clinical/regulatory updates, with commentary from our Expert Contributors.

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Interview

Taming the Last Frontier: Harmonizing the Upstream-Downstream Interface

Interview

Pete Gagnon

Upstream Bioprocessing Update

Pete is the Chief Scientific Officer of BIA Separations, a company that produces purification tools to advance the field of gene therapy. Prior to joining BIA, Pete was VP of Process Sciences for Avid BioServices, and before that, going back to 1987, President of Validated Biosystems, an international consulting firm specializing in downstream processing. He has worked with most of the major international biopharma companies, dozens of start-ups and intermediate size companies, and nearly all of the downstream processing suppliers in the field to develop solutions to a wide range of bioprocessing challenges. He is best known for his work in the field of antibody purification but has also worked extensively with other proteins, viruses, DNA plasmids, and RNA. He has been awarded more than 50 patents worldwide and written more than 100 publications addressing various aspects of bioprocessing. He is a frequent advisor and contributor to major conferences and serves on the editorial boards of BioProcess International and Genetic Engineering News.

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Determining the optimal culture system for your scale up strategy

Spotlight Article

Interview

Upstream Bioprocessing Update

Dr Clive Glover is Senior Global Marketing Manager, Cell & Gene Therapy, Pall Corporation, UK. Clive leads Pall’s cell and gene therapy business. Previously he was responsible for driving product development efforts around cell therapy at GE Healthcare and has also held positions in marketing and product management at STEMCELL Technologies. Clive holds a PhD in Genetics from the University of British Columbia.

Marco Koppe, Global Product Manager Cell Culture and Clarification at Pall Biotech, starts working with the Pallproducts in 2001. First at the Dutch distributor, followed atPall when it went directly to the Dutch market.In his previous role as a member of Pall Biotech ScientificLaboratory Services (SLS) team, His responsibility wasdeveloping clarification processes at (key) customers with the Pall products and involvements at (A)R&D on developing new products. Currently he is GPM for the iCELLis® technology.

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Challenges in upstream bioprocess development for viral vector production

Spotlight Article

Interview

Ankita Desai & Philipp Nold

Upstream Bioprocessing Update

Ankita Desai is a Bioprocess Field Application Specialist at Eppendorf North America. She supports customers with her expertise in cell culture bioprocessing. After her Master’s in Pharmaceutical Sciences at the Northeastern University in Boston, she has gained several experiences working for global players in the pharmaceutical industry.

Philipp Nold studied Biology at the Ruhr-University Bochum, Germany and holds a PhD in the same field from the University of Marburg. In December 2017 Dr Nold joined the Eppendorf Bioprocess Center as an Infield Application Specialist for stem cells. As part of this, he supports colleagues and customers worldwide with his expertise in stem cell bioprocessing and applications2.

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Determining the optimal culture system for your scale up strategy

Spotlight Article

Interview

Clive Glover and Marco Koppe

Upstream Bioprocessing Update

Dr Clive Glover is Senior Global Marketing Manager, Cell & Gene Therapy, Pall Corporation, UK. Clive leads Pall’s cell and gene therapy business. Previously he was responsible for driving product development efforts around cell therapy at GE Healthcare and has also held positions in marketing and product management at STEMCELL Technologies. Clive holds a PhD in Genetics from the University of British Columbia.

Marco Koppe, Global Product Manager Cell Culture and Clarification at Pall Biotech, starts working with the Pallproducts in 2001. First at the Dutch distributor, followed atPall when it went directly to the Dutch market.In his previous role as a member of Pall Biotech ScientificLaboratory Services (SLS) team, His responsibility wasdeveloping clarification processes at (key) customers with the Pall products and involvements at (A)R&D on developing new products. Currently he is GPM for the iCELLis® technology.

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A 3D vision for the future of tissue engineering

Spotlight Article

Interview

Suwan N Jayasinghe

Upstream Bioprocessing Update

Suwan N Jayasinghe Suwan N Jayasinghe leads the BioPhysics Group at University College London. Jayasinghe’s group has published over 170 scientific articles, which have been highlighted in many learned society journals, the popular press including news providers such as Reuters, BBC and the Associated Press. His group has made several discoveries having significance to advanced bioanalysis and diagnostics to tissue engineering and regenerative/therapeutic biology and medicine. These pioneering investigations are currently in and undergoing intense exploration for their exploitation in the clinic for repairing, replacing and rejuvenating damaged/diseased and/or aging tissues/organs.

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Key success criteria and factors for delivering scalable cell therapy upstream bioprocesses

Spotlight Article

Interview

Gautam Banik

Upstream Bioprocessing Update

Gautam Banik is head of Manufacturing and Process Sciences at Neurona Therapeutics where he is working on the development of a human embryonic cell-derived GABAergic interneuron cell product for the treatment of chronic refractory epilepsy and neuropathic pain. Prior to joining Neurona he was Vice President of Manufacturing and Process Sciences at Cellerant Therapeutics where he developed a myeloid progenitor stem cell product derived from adult donors for the treatment of neutropenia in acute myelogenous leukemia and acute radiation syndrome. Dr Banik also developed an antibody drug conjugate product for the treatment of AML for early phase clinical studies. Prior to Cellerant, Dr Banik worked in the Process Sciences group at Cell Genesys from 1997 to 2008. During this period, Dr Banik held a number of positions with increasing responsibility including leading the development of manufacturing processes and scale up to commercial scale for cell therapy products such as GVAX immunotherapy. He also worked on a number of gene therapy and viral vector products. Dr Banik conducted his post-doctoral research in Biochemical Engineering at the University of Colorado at Boulder and received his PhD in Engineering Sciences from Dartmouth College. Dr Banik is the author or co-author of several publications, patent applications and abstracts.

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Perspective

Creating a cell-friendly microenvironment to enhance cell culture efficiency

Spotlight Article

Perspective

Ou Wang & Yuguo Lei

Upstream Bioprocessing Update

Cells will be a major type of medicine. To achieve the full potential of cellular therapeutics, we must be able to cost-effectively and reproducibly manufacture cells at large scales and with high quality. Currently, robust and cost-effective culture of high-quality allogenic or autologous cells in large scales is still very challenging. Academia and industry are focusing on developing modular, disposable and closed bioreactors; automating the cell culture; integrating process analysis and control and artificial intelligence. This short article describes how the cell culture microenvironment impacts the cell culture outcome, and the critical need of creating a cell-friendly microenvironment during cell manufacturing.

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Expert Insight

Bioprocessing & biological challenges of large-scale red blood cell production from pluripotent stem cells: important factors to consider

Spotlight Article

Expert Insight

Jaichandran Sivalingam & Steve Kah-Weng Oh

Upstream Bioprocessing Update

Within just a decade of first deriving human induced pluripotent stem cells (hiPSCs) from somatic cells, continual advancements in the fields of genetic engineering, improved protocols for lineage differentiation and technological developments in bioprocessing and scale-up culture have brought closer the reality of using hiPSCs-differentiated cells for therapeutic applications and regenerative medicine. One such potential is the use of hiPSCs to generate universal red blood cells (RBCs) for transfusion applications. However, unlike most cell therapies, generating RBCs for clinical application poses unique bioprocessing and manufacturing challenges. The need to generate 2 trillion RBCs for each transfusion unit of blood (equivalent to 300 ml of donated blood) requires the development of closed-system bioprocesses capable of handling ultra-high density cultures of cells. In this review, we aim to highlight key challenges associated with developing manufacturing processes for scale-up culture of hiPSC-derived RBCs. Taking into consideration challenges such as the need for large-scale expansion of hiPSCs, culture intensification of erythroblasts, improved enucleation and separation of mature RBCs, and high cost of manufacture, we take a critical look at some of these bioprocessing and biological barriers and highlight critical factors that have to considered in order to circumvent these issues en route to developing a scalable-process for generating high density culture of RBCs from hiPSCs.

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