CELL & GENE THERAPY INSIGHTS

Vol 7 Issue 3

Apr 2021

FEATURING

Issue Spotlight: Viral vector bioprocessing

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Reports: Innovation Insights
Regulatory Insights

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Spotlight

Viral vector bioprocessing

Apr 2021
Guest Editor:
Anindya Dasgupta, Director, Vector Development at Expression Therapeutics
Anindya Dasgupta
Director, Vector Development at Expression Therapeutics
<p>Anindya is the director of vector development at Expression Therapeutics. He obtained his PhD from University of South Carolina, USA. His post-doctoral training and research associateship at the school of medicine, Emory University, Atlanta, USA, were focussed on the evaluation of novel anti-cancer therapies and the development of strategies for expansion and lentivirus based bioengineering of gamma delta; T cells in serum free media. Anindya is a co-inventor of a patent on anti-cancer strategy. At his recent role at Cincinnati Childrens Hospital Medical Centre he led vector development to manufacture high titer lentiviral vectors.</p>

Expert Insight

Gammaretroviral and lentiviral vector manufacture: brief overview

Ranjita Sengupta
Ranjita Sengupta
Adicet Bio, 200 Constitution Drive, Menlo Park, CA-94025, USA
29 April 2021
Expert Insight

Innovator Insight

Improving upon legacy vector and plasmid bioprocess technology for tomorrow’s advanced therapies

Henrik Ihre, PhD,
Henrik Ihre, PhD
Director Strategic Technologies, Cytiva
Henrik Ihre has his roots in biopharma, leadership and product development for the biopharma downstream industry in specific. He is motivated by bringing new solutions and manufacturing of new pharmaceuticals for patients developed by partners of Cytiva. He has been the Director of Strategic Technologies since March 2020 with specific knowledge and background in the downstream purification of biopharmaceuticals for over 20 years. 
Peter Guterstam, MD,
Peter Guterstam, MD
Product Manager, Next Generation Resins & Technologies, Cytiva
Peter is Global Product Manager at Cytiva with responsibility for products tailored for downstream processing of Advanced Therapy Medicinal Products. He is based in Uppsala, Sweden. Peter earned is PhD in Neurochemistry from Stockholm University in 2009. He has been with GE since 2003, primarily working in various roles associated with oligonucleotide synthesis and purification. Since GE’s acquisition of Puridify, Peter has the business responsibility to develop products based on the Fibro technology to complement Cytiva’s portfolio of chromatography resins and to develop it further to generate tailored solutions for the manufacture of Advanced Therapy Medicinal Products.
Mats Lundgren, PhD
Mats Lundgren, PhD
Customer Applications Director, Life Sciences, GE Healthcare, Sweden
Mats has more than 25 years of experience in the field of biotechnology. He holds a PhD in Immunology, Cell and Molecular Biology from the Karolinska Institute, Stockholm, Sweden and extensive post-doc training at the MRC Clinical Sciences Centre, Imperial College School of Medicine in London, UK. In his industrial career Mats has had positions as scientist, team manager and Vice President at Pharmacia, AstraZeneca and smaller biotech companies.  In his previous function, Mats was managing both the Cell line and Upstream Process Development teams at a major biotech company.  In his current role, Mats works across different viral vector and vaccine application projects as well as general upstream topics, focusing on customer support, applicability of new technologies and manufacturing solutions.
4 August 2021
Innovator Insight

Facilitating gene therapy development with solutions to four capsid analytical challenges

Susan Darling
Susan Darling
Senior Director Product Management, Market Management, CE and Biopharma, SCIEX
29 April 2021
Innovator Insight

Commentary

Yesterday, today and tomorrow: the evolving landscape of gene therapy manufacturing and process development

David R Knop, PhD
David R Knop, PhD
Vice President of Process Development, AGTC
29 April 2021
Commentary

Making the move from antibody therapeutics to gene therapy: applicability of monoclonal antibody learnings to adeno-associated virus vector bioprocessing

Andrew D Tustian
Andrew D Tustian
Regeneron Pharmaceuticals Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, USA andrew.tustian@regeneron.com
29 April 2021
Commentary

Interview

Current and future perspectives on lentiviral vector bioprocess and bioanalytical tools

Paul Carter
Paul Carter
Head of Vector Processing at Quell Therapeutics
Paul Carter is the Head of Vector Processing at Quell Therapeutics Limited and has over 30 years’ experience in the pharmaceutical industry, working across cell and gene therapy, biopharmaceutical and small molecule R&D. Prior to joining Quell, he was leading GSK’s Downstream Process Development Group in Cell and Gene Therapy.
4 May 2021
Interview

Keys to success for in-house lentiviral vector tech transfer and manufacture

Nicole Nuñez,
Nicole Nuñez
Regulatory Scientist, Eureka Therapeutics
Nicole Nuñez, PhD, joined Eureka Therapeutics in 2018 as a Process Development Scientist, and co-led the process development, manufacture, tech transfer, vendor management and regulatory compliance of lentiviral vectors to be used in the production of T-cell based therapies. Nicole currently serves Eureka as a Regulatory Scientist focusing on the development and implementation of regulatory strategy for the company’s T-cell therapy and vector products.
Liam Powers
Liam Powers
Process Development Research Associate, Eureka Therapeutics
Liam Powers joined Eureka Therapeutics as an intern in 2016 and is currently a Process Development Research Associate. His main focus has been the optimization and development of lentiviral vector production and purification systems. He led the engineering of Eureka’s GMP vector process and provided oversight in tech transfer and manufacturing operations.
29 April 2021
Interview

Improving AAV vector manufacture: a question of scale

Silke Wissing,
Silke Wissing
Chief Scientific Officer, Cevec Pharmaceuticals
Dr Silke Wissing has wide-ranging experience in the fields of virology, cell biology and cell line development, as well as molecular biology. Before joining CEVEC in 2011, she held a position as a group leader in the Gladstone Institute for Virology and Immunology, San Francisco, where she performed research in the field of HIV-1 biology, stem cell research and cell line development. Dr. Silke Wissing holds a PhD in Biochemistry from the University of Tübingen.
Juliana Coronel,
Juliana Coronel
Head of Upstream Process Development, Cevec Pharmaceuticals
Jans Wölfel,
Jans Wölfel
Head of Downstream Processing and Analytics, Cevec Pharmaceuticals
David Mainwaring,
David Mainwaring
Principal Scientist, Pall
Amar Joshi
Amar Joshi
Senior Scientist, Pall
29 April 2021
Interview

How fixed bed bioreactors are changing the game for adherent cell culture-based vector production

Todd Upton,
Todd Upton
Innovation Portfolio Senior Manager, Corning Research & Development Corporation
Todd Upton is a senior program manager at Corning Life Sciences. He has more than 25 years of experience developing biotechnology products for use in life sciences businesses, including 17 years at Corning. Prior to joining Corning, Todd was a senior researcher at Cytomatrix, LLC where he developed a novel bioreactor platform utilizing a rigid matrix for the large-scale culture of adherent cells. He also helped develop novel culture platforms for Hematopoietic stem cells. Todd holds a Ph.D. in Molecular Biology and Biochemistry from the University of Connecticut.
Vasiliy Goral
Vasiliy Goral
Research & Development Associate, Corning Research & Development Corporation
Vasiliy Goral is a research & development associate at the Corning Research & Development Corporation. He has 18 years of experience developing biotechnology products for use in life sciences businesses, including 14 years at Corning. Prior to joining Corning, Vasiliy was a senior researcher at Innovative Biotechnologies International, Inc., where he developed a microfluidic biosensor platform with applications in multiple markets such as point-of-care testing, national defense, and food/water testing. Vasiliy holds a PhD in chemistry from Moscow State University.
29 April 2021
Interview

Podcast

Improving AAV vector manufacture: a question of scale

Silke Wissing,
Silke Wissing
Chief Scientific Officer, Cevec Pharmaceuticals
Dr Silke Wissing has wide-ranging experience in the fields of virology, cell biology and cell line development, as well as molecular biology. Before joining CEVEC in 2011, she held a position as a group leader in the Gladstone Institute for Virology and Immunology, San Francisco, where she performed research in the field of HIV-1 biology, stem cell research and cell line development. Dr. Silke Wissing holds a PhD in Biochemistry from the University of Tübingen.
Juliana Coronel,
Juliana Coronel
Head of Upstream Process Development, Cevec Pharmaceuticals
Jens Wölfel,
Jens Wölfel
Head of DSP and Analytics at CEVEC Pharmaceuticals
David Mainwaring,
David Mainwaring
at Pall
Amar Joshi
Amar Joshi
at Pall Biotech
29 April 2021
Podcast

Infographic


FastFacts

Cell and gene manufacturing: a case study approach to overcoming challenges

Sean Werner
Sean Werner
President, Sexton Biotechnologies
Sean Werner, Presidnet, Sexton Biotechnologies. A manufacturer or processing and handling tools and reagents for the development and manufacture of cell and gene therapies. Sean received his PhD from Purdue University in Biology followed by post- doctoral positions at the Indiana University School of Medicine and Eli Lilly. Prior to his current role he spent 11 years with Cook Medical and Cook Regentec filling various roles in the global regulatory and general management functions supporting medical devices, autologous cell therapy, and single use disposable development programs. In his 15 years working in the life science industry, he has guided pre-clinical and clinical testing and submission strategies leading to global commercialization of multiple medical devices and bioprocessing tools.  
29 April 2021
FastFacts

Scalable, single-use technologies for purification of lentiviral vectors

Todd Sanderson
Todd Sanderson
Senior Manager – R&D Bioprocessing Group, Pall Corporation
Todd has been with Pall since 2006. He has over 20 years of research experience with expertise in mammalian cell culture, process development and analytical method development. He currently leads the US team of Upstream and Analytics within the R&D Bioprocessing Group. He holds a B.S. in Biochemistry and B.S. in Psychology from Michigan State University. When not at work, Todd enjoys gardening and spending time with his young children
29 April 2021
FastFacts

Efficient and scalable purification of mRNA using affinity chromatography

Zoltan Gulyas
Zoltan Gulyas
Field Applications Specialist, Purification, Thermo Fisher Scientific
Zoltan has a MSc degree in chemical engineering, and graduated from the University of Technology and Economics in Budapest, Hungary. He started his career with Gedeon Richter Plc. in Budapest as a process development scientist, where his main responsibility was to develop purification methods for small molecular pharmaceuticals using preparative scale HPLC. After 3 years he joined the biologics development team to purity recombinant proteins and monoclonal antibodies. During his 5 years as DSP scientist Zoltan gathered experience in process development, scale-up, technology transfer, process validation, manufacturing and filing of biologics. In 2017 he joined Thermo Fisher Scientific as a Field Applications Specialist for Purification covering primarily Northern Europe, and he has been supporting the use of POROS and CaputreSelect products for recombinant proteins, Mabs and derivatives, viral vectors and accines for past 3 years.  
29 April 2021
FastFacts

The Corning® Ascent Fixed Bed Reactor (FBR) System: Designed for high yield, scalable viral vector production & other applications for cell & gene therapies.

Zara Melkoumian
Zara Melkoumian
Senior Technology Manager, Corning Research and Development Corporation
Zara holds a PhD in Pharmacology and Toxicology and has 15 years of industry experience in bringing innovative cell culture products and technologies to market. Prior to joining Corning, Zara was a post-doctoral fellow at Cornell University where she studied the mechanism of action of a novel tumor suppressor gene in human breast cancer cells.
29 April 2021
FastFacts

The EuLV system: lentiviral vector production based on stable producer cell lines

Roy Bin Liu
Roy Bin Liu
Business Development Director
Roy Bin Liu Business Development Director, EurekaBio. Mr Liu graduated from the Hong Kong University of Science and Technology with a Masters degree in Biotechnology. He previously worked in Bio-techne and InvivoGen. Mr Liu joined Eureka Bio in 2016, and has extensive knowledge of the cell and gene therapy industry, and is experienced in business development, project management, process development, cGMP etc.
21 April 2021
FastFacts

Simplifying AAV protein analytics with Maurice

Chris Heger PhD
Chris Heger PhD
Director, Applications Science
Chris Heger, Senior Manager of Applications Science for the Analytical Solutions Division of Bio-Techne, leads a team chartered with creating scientific collateral, fostering collaborations, training, and coming up with new applications. Chris has expertise in immunoassays, capillary electrophoresis, antibody design and production, and chromatography. In recent years, his team has focused on developing analytical solutions for cell and gene therapy researchers.Chris received his doctoral degree in Pharmacology from Cornell University and completed his post-doctoral training at the National Cancer Institute. Working in the Antibody and Protein Purification Unit, Chris oversaw antibody development projects, from immunogen design to final product. A unique aspect of his postdoctoral training was his role in the evaluation of new technologies, serving as the gateway for cutting edge instrumentation to get into use at the NCI/NIH. Through this role, Chris became well-acquainted with ProteinSimple and after completing his postdoctoral training, began working for ProteinSimple (now part of Bio-Techne).
29 April 2021
FastFacts

Report

Interview

Stem cell therapy: current obstacles and innovations

Joshua Hare
Joshua Hare
Chief Sciences Officer, Senior Associate Dean for Experimental and Cellular Therapeutics, Director of the Interdisciplinary Stem Cell Institute (ISCI) and Louis Lemberg Professor of Medicine at the University of Miami Miller School of Medicine
22 March 2021
Interview

Shelfie

On my bookshelf...

Qasim Rafiq
Qasim Rafiq
In CGTI Shelfies, we ask experts within cell and gene therapy to pick the publications that helped shape their field, and their own careers. This week, we take a look into the bookshelf of Qasim Rafiq, Associate Professor in Cell and Gene Therapy Bioprocess Engineering at University College London.
Associate professor at UCL’s Advanced Centre for Biochemical Engineering, Qasim’s research focus is on addressing translational challenges of robust manufacture of stem cells that are needed to take regenerative medicines into the clinic. This includes the “whole bioprocess” from sourcing of raw materials and cells, through cell expansion in bioreactors and ultimately the downstream processing needed to purify and concentrate cell product for delivery to the patient. He previously lectured in Bioprocess Engineering at Aston University, where he was Principal Investigator on 4 grants with funding from RCUK, EU Horizon 2020, InnovateUK and commercial sources. Qasim completed his PhD at Loughborough.
16 March 2021
Shelfie

On my bookshelf...

Robert Deans
Robert Deans
CSO at Synthego Corporation
3 March 2021
Shelfie

Report

Perspective

Current status and future perspective of gene therapy products in Japan

Yoshiaki Maruyama,
Yoshiaki Maruyama
Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency
Akira Sakurai,
Akira Sakurai
Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency
Masaki Kasai,
Masaki Kasai
Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency
Shinichi Noda,
Shinichi Noda
Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency
Futaba Honda
Futaba Honda
Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency
11 March 2021
Perspective

Interview

Examining Health Canada’s agile new approach to regulating Advanced Therapeutic Products

Elizabeth Toller,
Elizabeth Toller
Executive Director, Regulatory Innovation (Health Products and Food Branch), Health Canada
Liz Anne Gillham-Eisen,
Liz Anne Gillham-Eisen
Director of the Office of Policy and International Collaboration, Health Canada
Nadine Kolas
Nadine Kolas
Senior Policy Analyst, Office of Policy and International Collaboration, Health Canada
19 March 2021
Interview

Latest articles

FastFacts

A demonstration of the Cocoon® platform: a bespoke solution to minimize manual touchpoints in cell therapy manufacturing

Joseph O’Connor
Joseph O’Connor
Senior Scientist, Personalized Medicine Business Unit, Lonza
Joseph O’Connor, PhD, is currently a senior scientist in process development for Lonza’s Personalized Medicine Business Unit. His focus is on translating and optimizing manual autologous cell therapies into the Cocoon® Platform, a closed and automated cell therapy manufacturing solution. Joseph earned a doctorate in chemical engineering from the Pennsylvania State University while researching the mechanical regulation of gene expression. He has been with Lonza since 2017.
21 April 2021
FastFacts

Webinars

FectoVIR®-AAV, the new tool to enhance recombinant AAV production for gene therapy

FectoVIR®-AAV, the new tool to enhance recombinant AAV production for gene therapy

Mathieu Porte
Mathieu Porte, Project Leader at Polyplus-transfection
Elisa Da Silva Ferrada
Elisa Da Silva Ferrada, USP Process Development Lead Scientist, Viralgen Vector Core (VVC)
Valerie Lang
Valerie Lang, Production Manger, Viralgen VC
24 March 2021
Webinar
Scalable suspension LVV production platforms for cell and gene therapy

Scalable suspension LVV production platforms for cell and gene therapy

Suparna Sanyal
Suparna Sanyal, Head of Viral Vectors Commercial Development, Lonza Pharma & Biotec
Michael Haller
Michael Haller, Senior R&D Scientist, Viral Vector Process Development, Lonza Pharma & Biotec
Young Shin
Young Shin, R&D Principal Scientist, Cell & Gene Technologies, Lonza Pharma & Biotec
13 April 2021
Webinar
Improving upon legacy vector and plasmid bioprocess technology for tomorrow’s advanced therapies

Improving upon legacy vector and plasmid bioprocess technology for tomorrow’s advanced therapies

Mats Lundgren
Mats Lundgren, Customer Applications Director, Life Sciences, Cytiva
Peter Guterstam
Peter Guterstam, Product Manager, Next Generation Resins & Technologies, Cytiva
Henrik Ihre
Henrik Ihre, Director Strategic Technologies, Cytiva
18 May 2021
Webinar
Key considerations for maximizing LV and AAV production in transient transfection workflows

Key considerations for maximizing LV and AAV production in transient transfection workflows

Leisha Kopp
Leisha Kopp, Applications Scientist, Mirus Bio LLC
Dr. Beth Larimore
Dr. Beth Larimore, Associate Director, Viral Vector Process Development, Juno Therapeutics, Inc
Anindya Dasgupta
Anindya Dasgupta, Director of Vector Development, Expression Therapeutics
Nolan Sutherland
Nolan Sutherland, Scientist, Bluebird Bio
9 June 2021
Webinar