Sessions

Reducing Timelines with Innovative Scale Up and Scale Out Technologies
End-To-End Manufacturing and Downstream Bioprocessing
Upstream Bioprocessing Optimisation and Support for Early Development
Achieving Operational Excellence in Cell and Gene Therapy Manufacturing
Key Considerations in Cell and Gene Therapy Manufacturing – CMC, Process and Regulatory

Reducing Timelines with Innovative Scale Up and Scale Out Technologies

27 Jan 2022
11:00
SPONSORED BY
Univercells Technologies
CAI

11:00 Chairperson’s Opening
Joseph Micsko, Global Director, Process Manufacturing Technology, CAI

11:05 Moving Our Clinical Process Into the Cocoon Bioreactor in Less Than A Year: A QbD approach

  • Importance of defining your Critical Quality Attributes ahead of the
  • implementation of the Scale-Up/Out process
  • Comparability studies as the centre piece of any Scale-Up/Out processes
  • Optimization of workflows and automation in order to tackle several products
  • at the same time

Arnaud Deladeriere, Director of Process Development, Triumvira Immunologics

11:25 Accelerating AAV Production From Gene to Clinic

George Buchman, VP, Preclinical Service & Process Development, Catalent Cell & Gene Therapy

11:45 Tackling Advanced Therapies Variability Challenges Through Integrated and Continuous Processing

  • Platform processes previously deployed are not adapted to ATMPs due to the encountered variability per indication To meet increasing demand for ATMPs with diverse applications scalable and flexible technologies become crucial
  • Appropriate scale-down models are key to de-risk scalability from R&D to commercial stage

Tania Pereira Chilima, Chief Technology Officer, Univercells Technologies

12:05 Panel Discussion & Speaker Q&A

Speakers

Arnaud Deladeriere
Director of Process Development
Triumvira Immunologics
George Buchman
Vice President, Preclinical Service and Process Development
Catalent Cell and Gene Therapy
Joseph Micsko
Global Director, Process Manufacturing Technology
CAI
Tania D. Pereira Chilima
Chief Technology Officer
Univercells Technologies