Herman & Erich Bozenhardt
Herman Bozenhardt has 44 years of experience in pharmaceutical, biotechnology, and medical device manufacturing, engineering, and compliance. He is a recognized expert in the area of aseptic filling facilities and systems and has extensive experience in the manufacture of therapeutic biologicals and vaccines. His current consulting work focuses on the areas of aseptic systems, biological manufacturing, and automation/computer systems. He has a B.S. in chemical engineering and an M.S. in system engineering, both from the Polytechnic Institute of Brooklyn.
Erich Bozenhardt, PE, is the process manager for IPS-Integrated Project Services’ process group in Raleigh, NC. He has 14 years of experience in the biotechnology and aseptic processing business and has led several biological manufacturing projects, including cell therapies, mammalian cell culture, and novel delivery systems. He has a B.S. in chemical engineering and an MBA, both from the University of Delaware.
-
![biopharm-facility-layout]( "Bioprocess Facility Design — Layout Rules And Configurations")
Bioprocess Facility Design — Layout Rules And Configurations12/9/2021The adoption of single-use systems (SUS) is allowing for a shift to smaller and more flexible facilities. This article explores modern facility design options and configurations, and best practices for building a facility around SUS process technology.
-
![Gears Solution]( "PIC/S Annex Update: What Is Your ATMP Control Strategy?")
PIC/S Annex Update: What Is Your ATMP Control Strategy?6/30/2021Recently, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) revised Annex 2 of its GMP guide addressing the manufacturing of advanced therapy medicinal products (ATMPs). While this guide is not an FDA or EMA guidance, it represents the consensus thoughts of a group that those regulators participate in.
