Lunch and Learn Speaker Series Fall 2020 Speaker:

Erich Bozenhardt, PE, MBA
Bioprocess Subject Matter Expert & Process Manager
Integrated Project Services, LLC

Abstract:
As new novel 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. Manufacturing facilities for cell and ex-vivo gene therapies are facing numerous challenges: therapies failing in clinical trials leaving abandoned assets, processes that are manual and not easily scaled out, and no long term industry platform to leverage. Facilities need to consider phased implementation, the ability to adjust to process development, segregation/efficiency balance and the logistics of small (many times one patient) batch sizes. These processes and facilities must evolve together to deliver on the potential of this class of therapies. This presentation will assess the array of therapies against the best practices and case studies of process / facility evolution.

Bio:
Erich Bozenhardt, PE, is a Process Manager and BioProcess Subject Matter Expert for IPS-Integrated Project Services in Raleigh, NC. He is a published author of over 30 technical papers, a conference presenter on process technologies and operations, and active in developing industry guidance documents. He has led several biological manufacturing projects, including over 12 cell therapy and ex-vivo gene therapy projects. He has a B.S. in chemical engineering and an MBA, both from the University of Delaware.