2015 BPD Header

Cambridge Healthtech Institute’s 2nd Annual
Cell Therapy Bioproduction
Bridging Clinical to Commercial Manufacturing of Cell Therapeutics
August 3-4, 2015
Part of CHI's 7th Annual The Bioprocessing Summit

August 3-7, 2015 | Westin Copley Place Hotel | Boston, Massachusetts


Continuing the discussions initiated at last year’s Cell Therapy Bioproduction conference and building upon the industry’s increasing knowledge and experience in this field, we have identified the top challenges that scientists and engineers are struggling with, which range from translation from bench to clinic, to commercial scaling up from 2D to 3D cultures, product characterization and analytics, QC and process validation, as well as commercialization hurdles such as COGS and procurement.

CHI’s Second Annual Cell Therapy Bioproduction aims to open the communication channels between pharma, academia and vendors by presenting first-hand case studies, practical examples, proven concepts and novel technologies to help provide potential solutions to these challenges.

Topics will include, but are not limited to:

INDUSTRY DEVELOPMENT AND REGULATORY CHALLENGES 

  • Developments in Cell Therapy
    • Translation from academic to clinic
    • Late stage clinical trials
  • Regulatory Approaches
    • Harmonization of Europe, Japan and US regulations
    • Regulatory perspective moving from 2D cultures to bioreactors
    • Compatibility vs bridging studies

PROCESS DEVELOPMENT AND MANUFACTURING 

  • Process Development Challenges for Allogeneic and Autologous Products
    • Developing commercializable processes
    • QbD approach to cell therapy manufacturing
  • Scale Up vs Scaling Out of Cell Therapy Processes
    • Autologous vs allogeneic cells
  • Analytics and Process Characterization
    • Developing Potency Assays
    • Determining CQA
    • Changing processes and the effect on expression profiles
    • Phenotypic profiling/ analysis
    • Rapid Testing
  • Standardization, Process Validation and Quality Control
    • Types of controls needed for BLA filing
    • QbD approach to process validation and comparability
  • Manufacturing Challenges for Cell Therapy Products
    • Tech transfer challenges
    • Release strategy
    • Facility design
    • Sterile and closed manufacturing system

COMMERCIALIZATION OF CELL THERAPY PRODUCTS 

  • COGS and Reimbursement Challenges
  • Procurement, Handling and Processing of Cells/Tissues
    • Challenges in sourcing GMP quality materials
    • Serum-free materials
    • Supply chain reliability
    • Globalization, local logistics and GMP regulations and transportation challenges
  • Shipping, Storage and Handling of Product in Clinic and Delivery to Patients
    • Preservation of Cells
    • Administration to Patients

If you would like to submit a proposal to give a presentation at this meeting, please click here.

The deadline for submission is January 30, 2015. 

All proposals are subject to review by the Scientific Advisory Committee to ensure the highest quality of the conference program. Please note that due to limited speaking slots, preference is given to pharmaceutical and biotech companies, regulators and those from academia. Additionally, vendors/consultants who provide products and services to these biopharmaceutical companies are offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships. 

For more details on the conference,
please contact:

Mimi Langley
Sr. Conference Director
Phone: (+1) 816-471-0701
Email: mlangley@healthtech.com 

For exhibit & sponsorship opportunities,
please contact:

Jason Gerardi
Manager, Business Development
Phone: 781-972-5452
Email: jgerardi@healthtech.com 

For media partnership opportunities,
please contact:

Kaushik Chaudhuri
Director of Product Marketing
Phone: 781-972-5419
Email: kchaudhuri@healthtech.com