Articles by Herman Erich Bozenhardt

1. Facility Considerations When Retrofitting Legacy Sites For ADCs 1/26/2026

   Antibody-drug conjugate manufacturing requires, among other things, unidirectional flow and air locks for people and materials. Facilities often lack these attributes.

2. Do's And Don'ts Of Material Handling When Retrofitting For ADCs 1/20/2026

   Antibody-drug conjugate manufacturing includes extremely dangerous ingredients, and most legacy facilities lack the features and flows for safe handling.

3. Mind The Potent Compounds When Retrofitting Facilities For ADCs 1/12/2026

   Antibody-drug conjugate manufacturing introduces significantly more risk to employees. Likewise, facility safety requirements are especially intense.

4. Who The Heck Designed This Biopharm Plant? 4/1/2024

   The Bozenhardts have seen some absurd, expensive facility design errors in their work. They talk about some of the worst ones here so you can avoid the same mistakes.

5. 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.

6. 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.

7. Help! The Particle Count Is Overwhelming Us! 12/12/2022

   Contamination issues can challenge any facility, especially legacy facilities and those with intense operational demands, financial pressure. Let's look at some of the most common particle origins and some solutions.  

8. Key Considerations For Decarbonizing Your Biotech Facility 5/4/2022

   Biopharmaceutical manufacturing processes do not directly utilize fossil fuels, but fossil fuels are used in the generation of raw materials, consumables, packaging, and in supplying energy to building systems and manufacturing equipment. This article looks at key facility decarbonizing considerations using a case study with quantification of estimated costs.

9. Facilities Remediation, Renovation & Reconstruction: When Does It End? 2/7/2022

   We sit at the beginning of 2022 amid the industry’s frantic and hurried effort to acquire, expand, and prepare more aseptic plant capacity — and to make it useable, compliant, and productive. This article provides a deep-dive on planning and design for your project, including walls, floors, ceilings, interstitial and mechanical spaces.

10. 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.