CELL & GENE THERAPY INSIGHTS

Cell therapy bioprocessing and analytics: today’s key tools and innovation requirements to meet future demand

Guest Editor:
John Paul Tomtishen III, Director of Manufacturing, Technical Operations at Legend Biotech Co.
John Paul Tomtishen III
Director of Manufacturing, Technical Operations at Legend Biotech Co.
John Paul Tomtishen III is currently employed by Legend Biotech where he serves as the Site Managing Director of Legend's corporate headquarters in Somerset, NJ and is responsible for Legend's back office functions, including Engineering/Facilities and Sourcing/Procurement. John also has oversight over Legend's US Manufacturing and Technical Operations teams and is responsible for developing robust global CMC strategies to ensure best-in-class, end-to-end manufacturing and supply chain capabilities for Legend's cell and gene therapy product portfolio.
November 2020

  • Cell therapy bioprocessing and analytics: today’s key tools and innovation requirements to meet future demand

    Cell therapy bioprocessing and analytics: today’s key tools and innovation requirements to meet future demand

    1 December 2020
    Foreword
    John Paul Tomtishen III
    John Paul Tomtishen III
    Director of Manufacturing, Technical Operations, Legend Biotech USA Inc.
    John Paul Tomtishen III is currently employed by Legend Biotech where he serves as the Site Managing Director of Legend's corporate headquarters in Somerset, NJ and is responsible for Legend's back office functions, including Engineering/Facilities and Sourcing/Procurement. John also has oversight over Legend's US Manufacturing and Technical Operations teams and is responsible for developing robust global CMC strategies to ensure best-in-class, end-to-end manufacturing and supply chain capabilities for Legend's cell and gene therapy product portfolio.
  • Celyad Oncology’s case study: validation approach for accelerated mycoplasma testing

    S Snykers
    Dr Sarah Snykers
    Cell Therapy Manufacturing Unit Director at Celyad
    Sarah is Director of the Cell Therapy Manufacturing Unit at Celyad, a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer. She has over 10 years of experience in cell therapy, biomedical research, development and quality control.She is a pharmacist from education and has a PhD in pharmaceutical and biomedical sciences, specialised in stem cell biology. In 2010, she joined Promethera BioSciences, a biopharmaceutical company dedicated to the development of cell therapy products based on allogeneic adult stem cell technology to treat liver diseases. She headed the R&D, QC and Preclinical Departments. In 2015, she joined Celyad. Sarah initially led the immune-oncology program at R&D level, focused on technology transfer, product characterization and optimization. In 2016, she became Head of the QC Department, covering release of clinical products and raw material, analytical method development and translational research activities. In 2020, all operational activities including Production, QC, Validation and Tech transfer of processes, methods, equipment, raw material and viral vector became under her responsibility.
    16 February 2021
    Webinars on Demand: Expert Commentary
  • Streamlining and optimizing viral vector bioprocess and analytical development

    J Tarnowski,
    Joseph Tarnowski
    Senior VP, Cell & Gene Therapy Platform, GlaxoSmithKline
    Joseph Tarnowski, Ph.D., Senior Vice President of Cell and Gene Therapy Platforms, Medicinal Science & Technology, R&D at GSK.  Experience in the research, development, registration and commercialization of products made using recombinant DNA technology.  Earned a B.S. degree in Chemistry from Southeast Missouri State University, a Ph.D. degree in Biochemistry from the University of Tennessee Center for the Health Sciences and was a post-doctoral fellow at the Roche Institute of Molecular Biology.  Held critical development roles for Roferon® A, Alpheron N®, Fiblast® Spray, CEPRATE® SC Stem Cell Concentration System, Natrecor®, Erbitux® Orencia®, Yervoy®, Nulojix®, Eperzan®/Tanzeum®, Nucala®, and Strimvelis™.  
    N Kotsopoulou,
    Nina Kotsopoulou
    Vice President of Cell And Gene Therapy Technologies, Orchard Therapeutics
    DR NINA (Ekaterini) KOTSOPOULOU is Vice President of Process Development at Autolus. She joined the UCL spin-out CAR-T company in 2015 and set-up the vector and CAR-T production process and analytics, including delivery of the first clinical patient batches. Nina has a BSc in Chemistry from the University of Athens and a DPhil in lentiviral vectors for gene therapy from Oxford University. Following her PhD, she briefly worked in her supervisors’ company, Oxford BioMedica, and went on to do 2 post-docs on haematopoietic stem cell biology, at Harvard Medical School and the University of Cambridge. She then joined GSK, where she initially led cell line development and associated process research for monoclonal antibodies and derivatives thereof. She then led Process Development for GSK’s Cell and Gene Therapy portfolio, including working with the inspirational team at TIGET, and completing the MAA submission for the first product, Strimvelis, for the treatment of ADA-SCID.
    K Patel et al.
    Kinnari Patel
    COO & Executive VP of Development, Rocket Pharmaceuticals
    She has fifteen years of rare disease Research & Development experience including in Regulatory Science, Pharmacovigilance, Policy and Quality Compliance gained at leading pharmaceutical companies including AstraZeneca, Bristol-Myers Squibb, Novartis, Hoffmann La-Roche and Pfizer. She has led both small molecule and biologic development programs from Phase I through Phase IV across multiple therapeutic areas including immuno-oncology, oncology, respiratory, virology, transplantation and metabolism. Kinnari received the dual degrees of B.S. in Biology and Doctorate of Pharmacy from the USciences in Philadelphia, PA. She also completed a two-year Post-Doctoral Regulatory Affairs Fellowship through Rutgers University. Additionally, she received her Executive MBA from NYU Stern School of Business with specialization in Corporate Finance, Leadership and Strategy. Most recently, she graduated from the C-Suite Harvard Business School Advanced Management Program.
    19 January 2021
    Expert Roundtable
  • Celyad Oncology’s case study: validation approach for accelerated mycoplasma testing

    S Snykers
    Dr Sarah Snykers
    Cell Therapy Manufacturing Unit Director at Celyad
    Sarah is Director of the Cell Therapy Manufacturing Unit at Celyad, a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer. She has over 10 years of experience in cell therapy, biomedical research, development and quality control.She is a pharmacist from education and has a PhD in pharmaceutical and biomedical sciences, specialised in stem cell biology. In 2010, she joined Promethera BioSciences, a biopharmaceutical company dedicated to the development of cell therapy products based on allogeneic adult stem cell technology to treat liver diseases. She headed the R&D, QC and Preclinical Departments. In 2015, she joined Celyad. Sarah initially led the immune-oncology program at R&D level, focused on technology transfer, product characterization and optimization. In 2016, she became Head of the QC Department, covering release of clinical products and raw material, analytical method development and translational research activities. In 2020, all operational activities including Production, QC, Validation and Tech transfer of processes, methods, equipment, raw material and viral vector became under her responsibility.
    7 January 2021
    On Demand Webinar
  • Abbreviated in-house qualification of real time mycoplasma detection kit

    S Viswanathan
    Sowmya Viswanathan, PhD
    Scientist, Krembil Research Institute
    Dr. Viswanathan is a Scientist at the Krembil Research Institute, University Health Network, and an Assistant Professor at the Institute of Biomaterials and Biomedical Engineering and at the Department of Medicine of the University of Toronto. Her research is focused on developing anti-inflammatory cell based therapies including next generation mesenchymal stromal cell (MSC) therapies and immunotherapies. Dr. Viswanathan’s lab is also focused on bioprocess optimization and translation of these cell-based therapies into clinical investigations. Dr. Viswanathan is a co-Principal Investigator of a recently completed trial using autologous MSCs to treat knee osteoarthritis patients, a North American first.As a translational scientist, Dr. Viswanathan chairs a Cell Therapy Stakeholder Group that engages Health Canada on cell therapy related policy issues. She serves on several committees at the International Society for Cell and Gene Therapy (ISCT) including the Mesenchymal Stromal Cell (MSC) committee and the North American Legal and Regulatory Affairs Committee. She is Associate Editor of Cytotherapy, the official journal for ISCT, and serves as an elected member of ISCT’s Board of Directors.
    7 January 2021
    On Demand Webinar
  • Streamlining and optimizing viral vector bioprocess and analytical development

    J Tarnowski,
    Joseph Tarnowski
    Senior VP, Cell & Gene Therapy Platform, GlaxoSmithKline
    Joseph Tarnowski, Ph.D., Senior Vice President of Cell and Gene Therapy Platforms, Medicinal Science & Technology, R&D at GSK.  Experience in the research, development, registration and commercialization of products made using recombinant DNA technology.  Earned a B.S. degree in Chemistry from Southeast Missouri State University, a Ph.D. degree in Biochemistry from the University of Tennessee Center for the Health Sciences and was a post-doctoral fellow at the Roche Institute of Molecular Biology.  Held critical development roles for Roferon® A, Alpheron N®, Fiblast® Spray, CEPRATE® SC Stem Cell Concentration System, Natrecor®, Erbitux® Orencia®, Yervoy®, Nulojix®, Eperzan®/Tanzeum®, Nucala®, and Strimvelis™.  
    N Kotsopoulou,
    Nina Kotsopoulou
    Vice President of Cell And Gene Therapy Technologies, Orchard Therapeutics
    DR NINA (Ekaterini) KOTSOPOULOU is Vice President of Process Development at Autolus. She joined the UCL spin-out CAR-T company in 2015 and set-up the vector and CAR-T production process and analytics, including delivery of the first clinical patient batches. Nina has a BSc in Chemistry from the University of Athens and a DPhil in lentiviral vectors for gene therapy from Oxford University. Following her PhD, she briefly worked in her supervisors’ company, Oxford BioMedica, and went on to do 2 post-docs on haematopoietic stem cell biology, at Harvard Medical School and the University of Cambridge. She then joined GSK, where she initially led cell line development and associated process research for monoclonal antibodies and derivatives thereof. She then led Process Development for GSK’s Cell and Gene Therapy portfolio, including working with the inspirational team at TIGET, and completing the MAA submission for the first product, Strimvelis, for the treatment of ADA-SCID.
    K Patel et al.
    Kinnari Patel
    COO & Executive VP of Development, Rocket Pharmaceuticals
    She has fifteen years of rare disease Research & Development experience including in Regulatory Science, Pharmacovigilance, Policy and Quality Compliance gained at leading pharmaceutical companies including AstraZeneca, Bristol-Myers Squibb, Novartis, Hoffmann La-Roche and Pfizer. She has led both small molecule and biologic development programs from Phase I through Phase IV across multiple therapeutic areas including immuno-oncology, oncology, respiratory, virology, transplantation and metabolism. Kinnari received the dual degrees of B.S. in Biology and Doctorate of Pharmacy from the USciences in Philadelphia, PA. She also completed a two-year Post-Doctoral Regulatory Affairs Fellowship through Rutgers University. Additionally, she received her Executive MBA from NYU Stern School of Business with specialization in Corporate Finance, Leadership and Strategy. Most recently, she graduated from the C-Suite Harvard Business School Advanced Management Program.
    22 December 2020
    Expert Roundtable Video
  • Cell therapy bioprocessing and analytics: today’s key tools and innovation requirements to meet future demand

    J Tomtishen III
    John Paul Tomtishen III
    Director of Manufacturing, Technical Operations, Legend Biotech USA Inc.
    John Paul Tomtishen III is currently employed by Legend Biotech where he serves as the Site Managing Director of Legend's corporate headquarters in Somerset, NJ and is responsible for Legend's back office functions, including Engineering/Facilities and Sourcing/Procurement. John also has oversight over Legend's US Manufacturing and Technical Operations teams and is responsible for developing robust global CMC strategies to ensure best-in-class, end-to-end manufacturing and supply chain capabilities for Legend's cell and gene therapy product portfolio.
    1 December 2020
    Foreword
  • De-risking the final formulation, fill and finish step in cell therapy manufacturing: considerations for an automated solution

    D Sethi,
    Dalip Sethi
    Manager, Scientific Affairs, Terumo Blood and Cell Technologies,
    Dalip currently serves as the scientific development lead for the Cell Therapy Technologies portfolio at Terumo BCT. He holds a doctorate degree and conducted post-doctoral studies at Thomas Jefferson University, School of Medicine. Prior to Terumo BCT, Dalip was engaged in the development of technologies & methods for use in autologous cell therapy applications. Throughout his career, Dalip has authored multiple scientific publications and is a co-inventor on several patents & patent applications.
    A Cunningham
    Annie Cunningham
    Cell Therapy Laboratory Scientist, Terumo Blood and Cell Technologies,
    26 November 2020
    Innovator Insight
  • Measurement: the central nervous system of a quality manufacturing line for tissue engineering and regenerative medicine products

    M McCorry,
    Mary Clare McCorry
    Advanced Regenerative Manufacturing Institute
    B Robinson-Zeigler,
    Rebecca Robinson-Zeigler
    Advanced Regenerative Manufacturing Institute
    R McFarland et al.
    Richard McFarland
    Advanced Regenerative Manufacturing Institute
    Richard McFarland, PhD, MD, joined ARMI as its Chief Regulatory Officer in May 2018 having been at the Food and Drug Administration’s Center for Biologics Evaluation and Research (FDA/CBER) where his career of over 16 years involved review of an extensive range of products and policy development in numerous areas inside FDA, across the federal government, and internationally. He spent almost two decades at the FDA, including time as Associate Director of Policy for FDA/CBER’s Office of Tissues and Advanced Therapies (OTAT), and its predecessor office, the Office of Cellular, Tissue and Gene Therapies (OCTGT).
    25 November 2020
    Expert Insight
  • Addressing pain points in iPSC-derived cell therapy manufacture and scale-up

    B Marques
    Bruno Marques, PhD
    Sr. Director, Process & Product Development, Century Therapeutics
    BRUNO MARQUES has been building and leading theProcess & Product Development team at Century Therapeuticssince 2019. Prior to Century, Bruno spent 14 years developingand commercializing biopharmaceutical products at Merck andGlaxoSmithKline. At GSK, he held leadership roles in process developmentand portfolio management, contributing to the launchof drugs such as Nucala (mepolizumab), and eventually joinedtheir Cell & Gene Therapy platform as Director of ManufacturingStrategy in support of autologous immunotherapies. Bruno is aChemical Engineer by training, with a PhD from Carnegie MellonUniversity and a BS from the Illinois Institute of Technology.
    24 November 2020
    Interview
  • A cell therapy media fill protocol for validation of aseptic processing of cord blood

    F DeDino,
    Faith DeDino
    Cleveland Cord Blood Center
    K Vincent,
    Kim Vincent
    Cleveland Cord Blood Center
    D DiNello et al.
    Denise DiNello
    Cleveland Cord Blood Center
    24 November 2020
    Methodology Paper
  • The role of flow cytometry in advanced therapy medicinal products

    T Nastos
    Theo Nastos, PhD
    Cell Analytics, Analytical Development, Cell & Gene Therapy PD&S, GSK R&D
    20 November 2020
    Expert Insight
  • Industrializing allogeneic cell therapy bioprocessing: devising streamlined solutions to complex challenges

    L Raviv
    Lior Raviv
    Vice President of Operations & Development, Pluristem
    Lior Raviv joined Pluristem in 2011 and currently serves as Vice President of Operations & Development. Prior to that Mr. Raviv served as Process development engineer and Projects manager & Product development Team leader at Pluristem. Prior to joining Pluristem and during the years 2010-2011, Mr. Raviv held the position of R&D Analytical Researcher at Teva Pharmaceutical Industries. Mr. Raviv holds a M.Med.Sec in pharmacology from the Ben Gurion University and a B.S.c, in Biotechnology engineering from the Ben Gurion University.
    23 November 2020
    Interview
  • γδ T cell therapy: devising a manufacturing-friendly bioprocess

    S O'Farrell
    Dr Sean O’Farrell
    Senior Scientist, GammaDelta Therapeutics Limited
    Sean O’Farrell is a Senior Scientist within the R&D team at GammaDelta Therapeutics Limited., a young, London-based biotech startup company exploiting the unique properties of human tissue and blood-resident γδ T cells as a novel immunotherapy for cancer and inflammatory diseases. Before joining GammaDelta Therapeutics, Sean undertook cross-institutional PhD and postdoctoral training in the laboratory of Professor Adrian Hayday at King’s College London and The Francis Crick Institute. During his PhD and postdoc, Sean worked in collaboration with GlaxoSmithKline to further understand the immunological mechanisms of action of adjuvanted influenza vaccination and how these might drive vaccine efficacy and/or adverse events in a clinical setting. Within his current role, his primary interests include process understanding and utilising design of experiments to improve product function and phenotype within the cell therapy field. Sean’s primary responsibility in the organisation is to bridge cell therapy culture processes from R&D to process development.
    17 November 2020
    Interview
  • Challenges & trends in stem cell-derived extracellular vesicle bioprocessing

    J Escobar Ivirico
    Jorge L Escobar Ivirico
    Senior Research Scientist, Eppendorf, Inc.
    12 November 2020
    Interview
  • Limiting variability to achieve reproducibility in cell manufacturing

    A Lamontagne,
    Anne Lamontagne
    MS
    A Fesnak
    Andrew Fesnak
    MD
    11 November 2020
    Expert Insight
  • Process development: how to win the race in cell & gene therapy

    R Baghirzade
    Ramin Baghirzade
    at AGC Biologics
    Dr Ramin Baghirzade is the Global Head of Business Development for Cell & Gene Therapy (C&GT) at AGC Biologics. With 15+ years of experience in life science and healthcare, Dr Baghirzade previously held roles of increasing responsibility at Roche and Lonza in global business development, strategic marketing and market intelligence functions. He holds a PhD Degree in Medical Sciences, as well as an MBA.
    4 November 2020
    Editorial
  • The right time to move to an automated manufacturing system like the Cocoon platform: the when, the why, and the how

    The right time to move to an automated manufacturing system like the Cocoon platform: the when, the why, and the how

    Matthew Hewitt
    Matthew Hewitt, Head, R&D and Clinical Development, Personalized Medicine
    Donna Rill
    Donna Rill, Chief Technology Officer at Triumvira Immunologics Inc
    3 December 2020
    Webinar
  • Focus on allogeneic CAR-Ts manufacturing challenges and solutions

    Focus on allogeneic CAR-Ts manufacturing challenges and solutions

    Marcos Langtry
    Marcos Langtry, Head of Allogeneic Cell Therapy - Commercial Development at Lonza
    Alex Sargent
    Alex Sargent, Scientist at Lonza
    Behnam Baghbaderani
    Behnam Baghbaderani, Global Head, Process Development, Emerging Technologies at Lonza
    5 November 2020
    Webinar