Articles by Herman F. Bozenhardt

11. Not Your Grandma's Aseptic Filling Line: Letting Go Of Tunnels, Washers, And Other Aseptic Vestiges 3/8/2019

    We often work with organizations adding capacity, transferring new products, and adding existing products from other sites into their “preferred” plants. In each case, the receiving site is focused on schedule and budget. These competing targets often distract personnel from embracing newer technologies, bypassing lower-cost options and faster implementation. 

12. Overcoming The Unique Filling Challenges Of Autologous Therapies 2/5/2019

    Autologous (patient-derived) therapies represent unique challenges to processing. One-patient, single-batch is a radical change from the scale our industry is accustomed to. At this level the filling is more analogous to limited Phase 1 clinical trial materials or even preclinical applications. The logistics and required compliance of manufacturing these personalized therapies is drastically different and presents a combinatorial explosive problem. One aspect of this process where traditional methods fall apart is filling of these therapies.

13. Renovating An Existing Biotech Plant To Accommodate A Higher-Titer Product 1/11/2018

    Today, a wide spectrum of plants are moving into their next generation of production of monoclonal antibodies (mAbs) and other therapeutic expressions. This new higher titer changes the way we look at both the process and the facility.

14. Biocontainment: An Intro To Control Levels & Practical Design Concepts 9/4/2017

    The first part of our design discussion covers various processes and their applicable BSL levels, to understand the risk levels and what types of processes must be contained. Finally, we will provide some practical (and required) design and building concepts that must be integrated into the GMP process to satisfy the FDA and EU.

15. Handling & Processing Of Potent Compounds: A Holistic Approach 5/5/2017

    The topic of potent compounds may seem obscure; however, it touches virtually every aspect of the biopharmaceutical business, from selection pressure in media to antibody-drug conjugates (ADCs). Every chemical and biological compound we work with has an MSDS (material safety data sheet) and an OEL (occupational exposure limit), which dictate how we must handle the compound and bring to the forefront issues of personnel safety and environmental impact that we must address in our manufacturing plants. When designing a process involving any potent compound, there are three aspects we must address directly: facilities, processing equipment, and people.