CELL & GENE THERAPY INSIGHTS

Cellular immuno-oncology – overcoming manufacturing and development obstacles to commercial success

Guest Editor:
Fritz Fiesser, Director, C&GT Engineering and Informatics at GlaxoSmithKline
Fritz Fiesser
Director, C&GT Engineering and Informatics at GlaxoSmithKline
June 2021

  • Accelerating CAR-T process development: The power of process insight

    Accelerating CAR-T process development: The power of process insight

    Julia Hupfeld, Ph.D.
    Julia Hupfeld, Ph.D., Advanced Therapies Expert, Sartorius
    29 July 2021
    38
    Days
    3
    Hrs
    19
    Min
    Webinar
  • Towards the rational design of a next-generation dendritic cell vaccine for cancer immunotherapy

    M Bravo,
    Marcelo Bravo
    University of Oxford, Sir William Dunn School of Pathology, South Parks Road, Oxford, OX1 3RE, UK
    T Davies,
    Timothy J Davies
    University of Oxford, Sir William Dunn School of Pathology, South Parks Road, Oxford, OX1 3RE, UK
    P Fairchild
    Paul J Fairchild
    Author for correspondence University of Oxford, Sir William Dunn School of Pathology, South Parks Road, Oxford, OX1 3RE, UK paul.fairchild@path.ox.ac.uk
    8 June 2021
    Commentary
  • Pursuing a fully closed cellular immunotherapy manufacturing model

    E Samuel
    Ed Samuel
    SVP Technical Operations, Achilles Therapeutics Ltd
    8 June 2021
    Interview
  • Optimizing manufacturing processes to develop novel cell and gene therapies

    K Ingalls
    Kerry Ingalls
    Chief Operating Officer, Poseida Therapeutics
    7 June 2021
    Interview
  • Reflecting upon the GSK–UCL collaboration on viral vector bioprocess economics for ex vivo gene therapy commercialization

    S Farid
    Suzanne S Farid
    Professor of Bioprocess Systems Engineering Advanced Centre for Biochemical Engineering at University College London
    Suzanne Farid is Professor of Bioprocess Systems Engineering at the Advanced Centre for Biochemical Engineering at University College London (UCL) and Deputy Head of Department (Education). She is Co-Director of the Future Targeted Healthcare Manufacturing Hub in collaboration with industrial and academic consortia to revolutionize the delivery of cost-effective stratified protein-based and personalized cell-based therapies to patients. She is also Director of the UCL-AstraZeneca Centre of Excellence. She leads research on ‘Decisional Tools’ to facilitate cost-effective bioprocess design, capacity planning, R&D portfolio management, root cause analysis and manufacturability assessments for biopharmaceuticals ranging from mAbs to cell and gene therapies. She sits on the ISCT Business Models and Investment Sub Committee, UK BioIndustry Association Manufacturing Advisory Committee and is a Fellow of the IChemE. She obtained her Bachelor’s and PhD degrees in Biochemical Engineering from UCL.
    25 May 2021
    Interview
  • Applying a closed, modular, semi-automated system to CAR T cell therapy manufacturing

    Applying a closed, modular, semi-automated system to CAR T cell therapy manufacturing

    Yongchang Ji
    Yongchang Ji, Manager of Product Applications, Cell and Gene Therapy, Thermo Fisher Scientific
    Semsi Ensari, PhD
    Semsi Ensari, PhD, Senior Director, Kite Pharma
    Nathan Moore, PhD
    Nathan Moore, PhD, Associate Director, Engineering & Automation Cell Therapies, Pharmaceutical Sciences, Takeda
    29 June 2021
    8
    Days
    3
    Hrs
    19
    Min
    Webinar
  • A bright commercial future for off-the-shelf NK cell therapy

    J Spanholtz,
    Jan Spanholtz
    Chief Scientific Officer, Glycostem Therapeutics
    T Jordansen,
    Troels Jordansen
    Chief Executive Officer, Glycostem Therapeutics
    Troels Jordansen started his career in healthcare at LEO Pharma. After four years with Johnson & Johnson Orthopaedics he was one of the initial Genzyme Europe hires to focus on commercializing Carticel and Epicel in 1996. Over the past 20 years Jordansen has worked for five different cell therapy companies including Dutch IsoTis NV, Australian Clinical Cell Culture Pty Ltd. and British Azellon Ltd. where he was co-founder. His roles have covered sales, marketing and general management; for the past 15 years he has been managing director and/or chairman for private and public listed companies. Jordansen has been part of award-winning management teams that have raised over €175 million in funding. He became Chairman of Glycostem in January 2014 and CEO in July 2016.
    V Huppert
    Volker Huppert
    Chief Development Officer, Glycostem Therapeutics
    Volker Huppert is a graduate bioprocess engineer from RWTH Aachen University. Among his achievements are participation in the set up of a quality system for a medical device/biotechnology company and development of several clinical-level reagents, disposable tubing sets and process software for cell separation and cell culture medical devices. He contributed to both the tubing set and process software development of a leading cell therapy-manufacturing device. Additionally, he managed projects and teams developing cell-manufacturing procedures for hematopoietic stem cells and Natural Killer cells. Volker has published 12 papers in peer reviewed journals over the past 20 years while working for a leading biotechnology company and is co-inventor of 9 patent families, including methods for T cell depletion of hematopoietic stem cell products, NK-cell transduction and NK-cell proliferation.
    11 May 2021
    Interview
  • CMC obstacles in cell and gene therapy: four solutions to solve six challenges

    S Viswanathan,
    Subbu Viswanathan
    Compliance Officer & Senior Vice President, Quality, Security and Compliance, Vineti, Inc.
    M Puich
    Marc Puich
    Senior Vice President, Business Development, Vineti, Inc.
    Marc focuses on leading the global sales activities for the Vineti Platform. Prior to joining Vineti Marc, held various positions at Werum IT Solutions, the leading provider of Manufacturing Execution Systems for the Pharmaceutical Industry. There, he was directly involved with sales and implementation of Werum’s PAS-X MES, as well as supporting organizations as they continued to drive benefits post go-live. Marc came to Werum with ten years consulting experience as a partner focused on the pharmaceutical and biotech sectors at Tefen USA. He holds a Bachelor’s in Physics from UC Berkeley and Master’s degree in Industrial Engineering and Engineering Management from Stanford University.
    10 May 2021
    Innovator Insight
  • Navigating regulations - novel cell therapy platforms and their path to clinical manufacturing

    Navigating regulations - novel cell therapy platforms and their path to clinical manufacturing

    Nina Bauer
    Nina Bauer, Head of Commercial, Gene Editing and Novel Modalities, Merck KGaA
    Natika Calhoun
    Natika Calhoun, Regulatory Consultant, Merck KGaA
    Anthony Davies
    Anthony Davies, Founder and CEO, Dark Horse Consulting
    Matt Muldoon
    Matt Muldoon, Senior Director, Supplier Management, Allogene Therapeutics
    27 May 2021
    Webinar