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

Towards the rational design of a next-generation dendritic...

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...

E Samuel
Ed Samuel
SVP Technical Operations, Achilles Therapeutics Ltd
8 June 2021
Interview

Optimizing manufacturing processes to develop novel cell...

K Ingalls
Kerry Ingalls
Chief Operating Officer, Poseida Therapeutics
7 June 2021
Interview

Reflecting upon the GSK–UCL collaboration on viral vector...

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

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
  • Addressing the challenges of purification & quality control in gene...

    A Bhattacharya,
    L Kopp,
    K Richter et al.
    Akash  Bhattacharya
    Akash Bhattacharya
    at Beckman Coulter Life Sciences
    Leisha Kopp
    Leisha Kopp
    Technical Applications Scientist at Mirus Bio LLC
    Klaus Richter
    Klaus Richter
    Expert Scientist & Group Leader, AUC at Coriolis Pharma Research
    Audrey Chang
    Audrey Chang
    Vice President of Quality Control and Analytical Service at Vigene Biosciences
    24 Jun 2021
    3
    Days
    18
    Hrs
    50
    Min
    Register
  • Assuring manufacturing and data integrity for cell and gene therapy...

    Jurlin,
    D Fridman
     Jelena Jurlin
    Jelena Jurlin
    Head of Compliance at Lonza
    Dmitry Fridman
    Dmitry Fridman
    Global Product Manager, Miltenyi Biotec B.V. & Co. KG at Miltenyi Biotec
    14 Jul 2021
    23
    Days
    18
    Hrs
    50
    Min
    Register
  • Expression systems for viral vector production: advantages of the Sf9...

    Y Li,
    S Kashi Ranganath
    Yi Fang Li
    Yi Fang Li
    RND Scientist at Thermo Fisher Scientific
    Srinath Kashi Ranganath
    Srinath Kashi Ranganath
    at Thermo Fisher Scientific
    22 Jul 2021
    31
    Days
    18
    Hrs
    50
    Min
    Register
  • Accelerating CAR-T process development: The power of process insight

    J Hupfeld
    Julia Hupfeld
    Julia Hupfeld
    Solution Marketing Manager at Sartorius
    29 Jul 2021
    38
    Days
    18
    Hrs
    50
    Min
    Register
  • Delivering an end-to-end industrialization roadmap for autologous cell...

    M Hewitt,
    J Garrity,
    W Bagni
    Matthew Hewitt
    Matthew Hewitt
    Head, R&D and Clinical Development, Personalized Medicine
    Joe Garrity
    Joe Garrity
    Head of Autologous Cell Therapy Commercial Development, CGT at Lonza
    Walter Bagni
    Walter Bagni
    Cell & Gene Technologies & Labelling CoE Lead at Lonza
    6 Jul 2021
    15
    Days
    18
    Hrs
    50
    Min
    Register
  • Applying a closed, modular, semi-automated system to CAR T cell therapy...

    Y Ji,
    S Ensari, PhD,
    N Moore
    Yongchang Ji
    Yongchang Ji
    Scientist II, Cell Transfection Group at Thermo Fisher Scientific
    Semsi Ensari, PhD
    Semsi Ensari, PhD
    Senior Director at Kite Pharma, Inc
    Nathan Moore
    Nathan Moore
    Associate Director, Engineering & Automation Cell Therapies, Pharmaceutical Sciences at Takeda Pharmaceutical Company Limited
    29 Jun 2021
    8
    Days
    18
    Hrs
    50
    Min
    Register
  • Improving upon legacy vector and plasmid bioprocess technology for tomorrow’s...

    M Lundgren,
    P Guterstam,
    H Ihre
    Mats Lundgren
    Mats Lundgren
    Customer Applications Director at Cytiva
    Peter Guterstam
    Peter Guterstam
    Product Manager, Advanced Therapeutics Downstream Solutions at Cytiva
    Henrik Ihre
    Henrik Ihre
    Director Strategic Technologies at Cytiva
    18 May 2021
    Watch now
  • Strategies to advance the donor selection process for cell therapies to improve...

    M Maiers,
    E Petersdorf,
    K Wadsworth et al.
    Martin Maiers
    Martin Maiers
    Vice President, Innovation at Be The Match BioTherapies
    Effie Wang Petersdorf
    Effie Wang Petersdorf
    Managing Director, Clinical Research Division at Fred Hutchinson Cancer Research Center
    Kim Wadsworth
    Kim Wadsworth
    Senior Immunogenetic Specialist at Be The Match BioTherapies
    Ray Sajulga
    Ray Sajulga
    Bioinformatics Scientist at Be The Match BioTherapies
    17 June 2021
    Watch now
  • Overcoming purification challenges in antibody therapeutics manufacturing with...

    L Sierkstra
    Laurens  Sierkstra
    Laurens Sierkstra
    Senior Director, Business Leader, Purification at Thermo Fisher Scientific
    10 June 2021
    Watch now
  • Key considerations for maximizing LV and AAV production in transient transfection...

    L Kopp,
    B Larimore,
    A Dasgupta et al.
    Leisha Kopp
    Leisha Kopp
    Technical Applications Scientist at Mirus Bio LLC
    Beth Larimore
    Beth Larimore
    Associate Director of Viral Vector Process Development at Bristol Myers Squibb
    Anindya Dasgupta
    Anindya Dasgupta
    Director, Vector Development at Expression Therapeutics
    Nolan Sutherland
    Nolan Sutherland
    Scientist, Upstream Vector Process Development
    9 June 2021
    Watch now
  • Navigating regulations - novel cell therapy platforms and their path to clinical...

    N Bauer,
    N Calhoun,
    A Davies et al.
    Nina Bauer
    Nina Bauer
    Head, Commercial, Gene Editing & Novel Modalities at MilliporeSigma
    Natika Calhoun
    Natika Calhoun
    Director, Quality Assurance, Viral & Gene Therapy at MilliporeSigma
    Anthony Davies
    Anthony Davies
    President at Dark Horse Consulting, Inc.
    Matthew Muldoon
    Matthew Muldoon
    Senior Director, Sourcing & Supplier Management
    27 May 2021
    Watch now
  • Protein biomarkers in plasma: revealing biological insights into the tumor...

    G Boland,
    A Mehta
    Genevieve  Boland
    Genevieve Boland
    Surgical Oncologist at Massachusetts General Hospital
    Arnav  Mehta
    Arnav Mehta
    Postdoctoral Researcher at Broad Institute of MIT and Harvard
    20 May 2021
    Watch now
  • Channel content

    Reports

    FEATURING

    Regulatory CMC in cell and gene therapy: navigating an evolving space

    L Starke
    Lawrence C. Starke
    Global RA-CMC Policy and Intelligence, Cell & Gene Therapy, Novartis
    Lawrence C. Starke is currently head of Regulatory CMC Policy and Intelligence at Novartis Pharmaceuticals Corporation in East Hanover, NJ. Prior to assuming his currently role, Dr. Starke was RA-CMC Unit Head for Cell and Gene Therapy Products at Novartis and held positions of increasing responsibility within the biologic RA-CMC roles at Eli Lilly and Company and at Merck. Dr. Starke received his Ph.D. in Cell and Molecular Biology at Duke University in Durham, North Carolina and was a research associate at Baylor College of Medicine in Houston, Texas prior to his career in the pharmaceutical industry.

    FEATURING

    2021: a key year for allogeneic cellular cancer immunotherapy?

    S Kili
    Sven Kili
    Principal, Sven Kili Consulting Ltd, UK
    Sven Kili provides specialist strategic consulting services to innovative Regenerative Medicine companies. His clients include small and medium sized companies from company formation through to clinical development and commercialisation. He was previously the Head of Development for the Cell and Gene Therapy division of GSK Rare Diseases where he led teams developing ex-vivo Gene Therapies for a variety of rare genetic disorders including Strimvelis®, the first ex-vivo gene therapy to be approved for children with ADA-SCID; Wiskott – Aldrich syndrome (WAS); Metachromatic Leukodystrophy (MLD) and Beta-Thalassemia. Prior to this, he was Senior Director, Cell Therapy and Regenerative Medicine for Sanofi (Genzyme) Biosurgery where he led the clinical development, approval and commercialisation activities of the first combined ATMP approval in the EU for MACI®. His team also prepared and submitted Advanced Therapy regulatory filings for Australia and the US, including health technology assessments and he was responsible for late stage developments for Carticel® and Epicel® in the US. Before joining Genzyme, Sven led the cell therapy activities and oversaw all UK & Irish regulatory functions and was the QPPV for pharmacovigilance for the Geistlich Pharma. Sven trained as an Orthopaedic surgeon in the UK and South Africa and since leaving full-time clinical practise has developed expertise Cell and Gene Therapy in clinical development, regulatory compliance, value creation, risk management and product safety, product launches and post-marketing activities. He sits on the board of CCRM in Canada; Xintela – a Swedish Stem Cell company and is the chair of the CGTAC as part of the UK BIA and the VP of the Standards Co-ordinating Body for Regenerative Medicine. Additionally, he still maintains his clinical skills in the UK NHS and serves as an ATLS Instructor in his spare time.

    FEATURING

    Business Insight: cell & gene therapy

    J Mulryne,
    Jackie Mulryne
    Partner, Arnold & Porter
    Jackie Mulryne is a Partner at Arnold & Porter, focusing on regulatory and contentious matters for life sciences companies. She has advised a range of clients on the development and launch of innovative products, and assisted with navigating the regulatory landscape for novel cell and gene therapy products.
    B San Martin,
    Dr Beatriz San Martin
    Partner, Arnold & Porter
    Beatriz San Martin is an intellectual property specialist focusing her practice on the life sciences sector and emerging/disruptive technologies. She has significant experience handling cases before the UK Courts and the Court of Justice of the European Union, including high-profile European litigation. Beatriz was formerly a scientist with a Wellcome Trust PhD and a postdoctoral from the University of Cambridge specializing in genetics, cellular, and molecular biology. She is a member of the UK BioIndustry Association Cell and Gene Therapy Advisory Committee and Engineering Biology Advisory Committee.
    J Schmidt et al.
    John Schmidt
    Partner, Arnold & Porter

    FEATURING

    Boldly de-risking development of impactful cell and gene therapies: the California Stem Cell Agency’s $3B funding model

    S Patel,
    Shyam Patel
    Associate Director, Portfolio Development & Review at California Institute For Regenerative Medicine
    S Talib,
    Sohel Talib
    Director, Therapeutics at California Institute For Regenerative Medicine
    M Millan
    Maria Millan
    Vice President, Therapeutics at California Institute For Regenerative Medicine

    Driving disruptive innovation in the ATMP field

    K Papenfuss
    Kerstin Papenfuss
    Associate Director, Therapeutics at Deep Science Ventures
    Kerstin Papenfuss started her PhD at German Cancer Research Centre and then moved to a lab at Imperial College London to work on novel treatment options within the field of tumor immunology. After a Post Doc in academic drug discovery, she since has spent almost ten years in leadership roles at impact-driven organizations advancing medicine and therapeutics, while also securing an executive MBA and a Women in Business award. Before joining DSV to develop science companies designing more effective therapies, Kerstin was transforming ideas for cutting edge cell and gene therapies into investable propositions at UK’s Cell and Gene Therapy Catapult.

    Latest content

    Expression systems for viral vector production: advantages of the Sf9...

    Y Li,
    S Kashi Ranganath
    Yi Fang Lee
    Yi Fang Lee
    R&D Scientist, Thermo Fisher Scientific
    Srinath Kashi Ranganath
    Srinath Kashi Ranganath
    Staff Scientist – Field Applications, Thermo Fisher Scientific
    22 Jul 2021
    31
    Days
    18
    Hrs
    50
    Min
    Register

    Assuring manufacturing and data integrity for cell and gene therapy...

    Jurlin,
    D Fridman
    Jelena Jurlin
    Jelena Jurlin
    Head of Compliance, Lonza
    Dr. Dmitry Fridman
    Dr. Dmitry Fridman
    Global Product Manager, Miltenyi Biotec B.V. & Co. KG
    14 Jul 2021
    23
    Days
    18
    Hrs
    50
    Min
    Register

    Addressing the challenges of purification & quality control in gene...

    A Bhattacharya,
    L Kopp,
    K Richter et al.
    Dr. Akash Bhattacharya
    Dr. Akash Bhattacharya
    Senior Application Engineer, Beckman Coulter
    Leisha Kopp
    Leisha Kopp
    Applications Scientist, Mirus Bio
    Klaus Richter, PhD
    Klaus Richter, PhD
    Group Leader AUC, Coriolis Pharma
    Dr. Audrey Chang
    Dr. Audrey Chang
    Vice President of Quality Control and Analytical Service, Vigene Biosciences
    24 Jun 2021
    3
    Days
    18
    Hrs
    50
    Min
    Register

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

    M Lundgren,
    P Guterstam,
    H Ihre
    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
    Watch now