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Informa

September 25-28, 2017
Hynes Convention Center,
Boston, MA

The complete event focusing on relieving bottlenecks and pain points in the clinical development, manufacture, and commercialization of cell, gene and immunotherapies

Three Focused Tracks

Bioprocessing
  • Reducing labor, time and cost in bioprocess analysis and characterization

  • Relieving bottlenecks in gene therapy bioprocessing

  • Advancing transduction for gene therapy bioprocessing

  • Advances in CAR-T Cell manufacturing

  • Developing and validating potency assays

Commercialization
  • Commercialization strategy case studies
  • Logistics and supply chain management
  • Establishing and managing an allogeneic therapy supply chain
  • Biopreservation, cryopreservation and storage for cell and gene therapies
  • North American regulatory, policy and healthcare landscape change

  • International Commercialization / Regulatory strategies

NEW! Clinical Developments
  • Designing late stage clinical trials for success

  • Regulatory update on expectations surrounding potency assays

  • Process Validation Strategies in the Clinic   

  • Supply Chain Challenges when Anticipating Transfer from the Clinic to Commercial Scale 

  • Raw material supply and quality agreements

  • Control strategy and the clinical trials experience 

Present a Scientific Poster


Highlight your company's latest research findings by presenting a scientific poster, which will be displayed in the exhibit & poster hall during the event. The deadline to submit your poster is August 25, 2017.

Progress Toward Commercial Scale and Efficiency in Cell Therapy Bioprocessing


Cell and gene therapy is an extremely promising and growing medical technology sector with 631 ongoing clinical trials at the end of 2015. It is applicable to oncology, cardiovascular disease, infectious diseases and other diseases. The merit of cell and gene therapy has been demonstrated by FDA approvals, however commercialisation can prove a high hurdle that can trip up even approved therapeutics such as Dendreon’s Provenge autologous cell therapy. There are however steps that can be taken to reduce the risk associated with commercialisation that companies with a cell and gene therapy portfolio should consider. This whitepaper discusses practical measures to improve the chances of commercial success:

  • Characterization and Comparability Risk reduction through Quality by Design (QbD)
  • Improving efficiency and reducing costs in development and production
  • Novel analytical technologies and methodologies
  • Ensuring successful process scale up and transfer
  • Progress towards the industrialization of cell and gene therapies through modularisation