Articles by Herman & Erich Bozenhardt

1. Shocking! Biotech Facilities Don't Maintain Themselves 3/4/2024

   Don't get trapped in the misconception that only core process systems need maintenance. Here are some real-life examples of facility maintenance programs gone wrong.

2. Let’s Clean Up That Bioburden — The Aseptic Suite’s Persistent Plague 2/16/2024

   After decades of helping to rescue biotech and pharma companies from environmental monitoring excursions, Herman and Erich Bozenhardt bring this discussion about specific problems you should avoid.

3. Bioprocess Facility Design — Layout Rules And Configurations 12/9/2021

   The 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.

4. An Introduction To Biopharma Facility Design & Layout 10/11/2021

   This article explores modern facility design principles that make use of the most flexible new technologies and provide a platform to rein in costs, reduce schedules, and deliver products compliantly and within business risk tolerance.

5. Expansion Options For Adherent Cell Therapy 8/4/2021

   While the stirred tank bioreactor is the workhorse of the biopharmaceutical industry, there are applications for which cells can’t be effectively cultured in suspension. Beyond the petri dish and the T-flask, many in our business have not had interactions with the numerous and sometimes niche solutions for adherent cell culture. This article discusses our options in this field.

    

6. PIC/S Annex Update: What Is Your ATMP Control Strategy? 6/30/2021

   Recently, 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.