Process Economics: The Driving Force behind the Criteria for Cell Therapies Facility Design

Process Economics: The Driving Force behind the Criteria for Cell Therapies Facility Design

04/17/2018, 4:15 PM - 5:00 PM

Technical Conference Stage 1, Booth 1076, Exhibit Hall


Today's small number of approved cellular therapy products (13 FDA-approved), a large number of clinical trials (>10,000), and favorable regulatory climate, as seen by the creation of the FDA's new Regenerative Advanced Therapy designation, increase the possibility of a large gap in manufacturing capacity occurring in the not-so-distant future. As new cell therapies come to market over the next few years, the industry will need to mobilize rapidly and build commercial production facilities that are dedicated to these therapies yet flexible enough to adapt to evolving needs that vary significantly with factors like the type of therapy, patient population, and process closure. We look at the differing cell therapies out today, their commonalities, and challenges. We examine the process economics that drive the type of facility for which to house the therapies. And, ultimately taking all factors into consideration, we design a facility for the "now" and the future.


  • Erich Bozenhardt


    Process Engineer


  • Larissa Esposito


    Marketing Assistant

    IPS-Integrated Project Services, LLC

Type of Session

  1. Type of Session

Learning Objectives

  1. Learning Objectives 1. Review current environment in the cell therapy market. 2. Understand that not all cell therapies are the same, thereby influencing the process economics 3. Understand how the process economics impacts cell therapy facility design. 4. Review facility concepts and examples for flexibility, reliability, and cost-effectiveness.


  1. Track
    Optimizing Facilities through Innovation & Technologies

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