CELL & GENE THERAPY INSIGHTS

Tools of tomorrow

December 2020

  • Viral vector production process intensification: analytics, automation, in-line testing and more

    S D'Costa,
    Susan D’Costa
    Senior Director, Technical Program Design in the Commercial Operations team for Viral Vector Services, Thermo Fisher Scientific
    Susan D’Costa is currently the Sr. Director, Technical Program Design in the Commercial Operations team for Viral Vector Services, Thermo Fisher Scientific.  In this role, she functions as SME for VVS’ viral vector manufacturing platforms and systems providing scientific and technical input for customer programs.  Prior to this role, she served as the Head of Process and Analytical Development at Viral Vector Services, Thermo Fisher Scientific, formerly Brammer Bio for over three years.  In her role as head of PD/ADA, she provided critical scientific input for projects developed and manufactured at VVS.  She has built a robust team for the development, customization, optimization, scale-up and tech transfer of gene therapy vector process and analytics.  Susan was also integral to developing robust QC analytics for incoming starting and raw materials and for the release of the clinical vector products in her role as Director of Quality Control at Brammer Bio/Florida Biologix.  She holds a Ph.D. in Molecular Virology and has over 20 years of experience in molecular virology.
    M Delahaye,
    Michael Delahaye
    Head of Viral Vector Industrialization, Cell & Gene Therapy Catapult
    Michael is the Head of Viral Vector Industrialisation at the Cell and Gene Therapy Catapult and has almost 15 years of industrial experience within the cell and gene therapy sector. He leads a team of experienced scientists within the Viral Gene Delivery programme, responsible for managing the developmental output of the group within collaborative, commercial and supporting R&D operations. The team’s key focus is the development and delivery of robust manufacturing processes, supported by rapid, high resolution characterisation tools to facilitate the production of AAV based gene therapies. His team is also supporting the development of new adaptive manufacturing approaches by integrating technologies to allow real-time product monitoring and enable feedback control during product manufacture
    M DiBiasio-White et al.
    Michael DiBiasio-White
    Senior Scientist at Affinia Therapeutics
    Michael J White, Senior Scientist at Affinia Therapeutics where he is leading the process development efforts focused on novel AAV vector variants. Before joining Affinia, Michael held roles at Ring therapeutics where he led teams focused on designing processes and developing novel viral vector technologies for Anelloviruses.
    9 February 2021
    Expert Roundtable
  • Viral vector production process intensification: analytics, automation, in-line testing, and more

    S D'Costa,
    Susan D’Costa
    Senior Director, Technical Program Design in the Commercial Operations team for Viral Vector Services, Thermo Fisher Scientific
    Susan D’Costa is currently the Sr. Director, Technical Program Design in the Commercial Operations team for Viral Vector Services, Thermo Fisher Scientific.  In this role, she functions as SME for VVS’ viral vector manufacturing platforms and systems providing scientific and technical input for customer programs.  Prior to this role, she served as the Head of Process and Analytical Development at Viral Vector Services, Thermo Fisher Scientific, formerly Brammer Bio for over three years.  In her role as head of PD/ADA, she provided critical scientific input for projects developed and manufactured at VVS.  She has built a robust team for the development, customization, optimization, scale-up and tech transfer of gene therapy vector process and analytics.  Susan was also integral to developing robust QC analytics for incoming starting and raw materials and for the release of the clinical vector products in her role as Director of Quality Control at Brammer Bio/Florida Biologix.  She holds a Ph.D. in Molecular Virology and has over 20 years of experience in molecular virology.
    M Delahaye,
    Michael Delahaye
    Head of Viral Vector Industrialization, Cell & Gene Therapy Catapult
    Michael is the Head of Viral Vector Industrialisation at the Cell and Gene Therapy Catapult and has almost 15 years of industrial experience within the cell and gene therapy sector. He leads a team of experienced scientists within the Viral Gene Delivery programme, responsible for managing the developmental output of the group within collaborative, commercial and supporting R&D operations. The team’s key focus is the development and delivery of robust manufacturing processes, supported by rapid, high resolution characterisation tools to facilitate the production of AAV based gene therapies. His team is also supporting the development of new adaptive manufacturing approaches by integrating technologies to allow real-time product monitoring and enable feedback control during product manufacture
    M DiBiasio-White et al.
    Michael DiBiasio-White
    Senior Scientist at Affinia Therapeutics
    Michael J White, Senior Scientist at Affinia Therapeutics where he is leading the process development efforts focused on novel AAV vector variants. Before joining Affinia, Michael held roles at Ring therapeutics where he led teams focused on designing processes and developing novel viral vector technologies for Anelloviruses.
    18 January 2021
    Expert Roundtable Video
  • Tools for tomorrow: expression without cells

    J Tuck,
    Jade Tuck
    CPI Biologics, 1 Union Square, Central Park, Darlington, County Durham, UK, DL1 1GL
    S Jamieson,
    Stuart Jamieson
    CPI Biologics, 1 Union Square, Central Park, Darlington, County Durham, UK, DL1 1GL
    P Probert
    Philip Probert
    CPI Biologics, 1 Union Square, Central Park, Darlington, County Durham, UK, DL1 1GL
    8 January 2021
    Commentary
  • The engineer’s perspective: evolution in cell therapy bioprocess automation

    B Parsad
    Brijender Parsad
    Senior Manager, Corporate Engineering Group, Kite
    Brijender Parsad has been involved with process control and automation field for over 25 years. Currently he is a Senior Manager, Corporate Engineering Group for Kite, a Gilead Company. Kite is singularly focused on cell therapy — the use of genetically modified immune cells programmed to target tumors. Previously he worked for Novartis, Dupont, Georgia Pacific and as a consultant in automation engineering for chemical, biotech and pharma industries.
    23 December 2020
    Interview
  • Detection of extracellular analytes via nanoscale optical sensors

    I Acosta,
    Ivon Acosta
    Department of Biological Systems Engineering, University of Nebraska
    A Haworth,
    Abigail Haworth
    Department of Biological http://admin.insights.bio/Articles/Edit/1888#Systems Engineering,
    B Francis et al.
    Becca Francis
    Department of Biological Systems Engineering
    5 January 2021
    Review
  • Redeploying biopharma process development and validation best practices for cell and gene therapy

    S Aldington
    Suzanne Aldington
    Director in the Cell and Gene Therapy Technology group at Orchard Therapeutics in London
    Suzanne Aldington is a Director in the Cell and Gene Therapy Technology group at Orchard Therapeutics in London, where she has worked since the beginning of 2020. Previously she was at Lonza, a Contract Manufacturer based in Slough, UK for 20 years. During this time her experience included purification process development, scale up activities at non GMP pilot scale and subsequent process transfers into GMP manufacturing facilities. In addition, she gained considerable experience in process validation including supporting multiple on site inspections by the FDA and other Health Agencies. She has over 30 years experience in academia and in the biotechnology industry. After completing a degree in Microbiology at Imperial College, she studied for a PhD in biochemical engineering at Birmingham University which included purification of an enzyme produced in microbial culture.
    23 December 2020
    Interview
  • An innovative collaborative approach towards the development of gene therapies for rare and ultra-rare genetic disorders of the CNS

    L Lisowski,
    Leszek Lisowski, PhD, MBA
    Head, Translational Vectorology Research Children’s Medical Research Institute (CMRI)
    W Gold
    Wendy Gold
    Group leader, Molecular Neurobiology Research Laboratory, Kids Neuroscience Centre, Kids Research, The Children’s Hospital at Westmead
    23 December 2020
    Interview
  • An innovative collaborative approach towards the development of gene therapies for rare and ultra-rare genetic disorders of the CNS

    L Lisowski,
    Leszek Lisowski, PhD, MBA
    Head, Translational Vectorology Research Children’s Medical Research Institute (CMRI)
    W Gold
    Wendy Gold
    Group leader, Molecular Neurobiology Research Laboratory, Kids Neuroscience Centre, Kids Research, The Children’s Hospital at Westmead
    22 December 2020
    Podcast
  • Widening the reach of induced pluripotent stem cell-based therapy

    G Hamilton
    Geoff Hamilton
    Co-founder and Chief Executive Officer of Stemson Therapeutics
    16 December 2020
    Interview
  • What to expect in 2021: seven cell and gene therapy commercialization trends

    H Hagen
    Heidi Hagen
    Co-founder and Advisor, Vineti
    Heidi has been an Operations Executive in the Biotechnology industry for over 25 years and is a Co-founder of Vineti. She has an extensive and proven track record in leading operations and commercializing innovative technologies ranging from recombinant protein/device combinations to the first active immune cell therapy, Provenge. Previously, Heidi was the Global COO for SOTIO, in Prague, Czech Republic with a US office in Boston, MA. Before joining SOTIO she worked for Dendreon for ten years as Senior Vice President of Operations and ten years with Immunex Corporation in a range of roles in drug development and operations management. Heidi has a B.S. in Cell and Molecular Biology, an MS in Bioengineering, and an MBA from the University of Washington.
    10 December 2020
    Innovator Insight