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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

registration deadline

Online registration closes on Thursday, September 21.

Biotech Week Boston App is Now Live


All registered attendees  should have received an email from 'Biotech Week Boston' containing log-in information for the Biotech Week Boston App, which allows you to view the attendee list, send private messages and schedule meetings before, during and after the event.  If you need your log in details or have questions, please contact biotechweekboston@knect365.com.

Be sure to download the 'Biotech Week Boston' app on your iPhone or Android, or log in at https://connect.jujama.com/BiotechWeekBoston17.

Dive Into Three Focused Topic Areas for New Insights and Data

NEW! Clinical Development
  • 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 

Bioprocessing
  • Reducing labor, time and cost in bioprocess analysis and characterization
  • Implementing closed and automated bioprocessing systems
  • Addressing particulates, leachables and extractables
  • Relieving gene therapy bottlenecks such as viral vector supply
  • Discovering the potential in big data processing and analytics
  • Advancing CAR-T Cell manufacturing
Commercialization
  • Sharing commercialization strategy case studies
  • Establishing and managing allogeneic and autologous supply chains
  • Advances in biopreservation, cryopreservation and point of care processing
  • North American regulatory landscape change and experiences
  • International commercialization and regulatory strategies and experiences

2 Events for the Price of 1


New this year, your Cell & Gene Therapy Bioprocessing & Commercialization main conference pass also grants you access to the scientific sessions at our the co-located meeting, BioProcess International Conference & Exhibition.

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

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