Articles by Herman F. Bozenhardt

1. Manufacturing Therapeutics In Hospitals: Re-envisioning The Bioprocessing Paradigm 4/19/2021

   Most hospital-based therapies are “patient ready,” pulled from inventory and used with minimal preparation. However, advanced therapy medicinal products (ATMPs) are changing how we think about how we deliver therapies. The success of these new and complex therapies requires partnership with those administering them, which is a new paradigm.

2. Future Delivery Models For ATMPs: Practical Considerations 2/17/2021

   With a small number of approved cell therapies/ex-vivo gene therapies, and with those approved therapies reaching small patient populations, there is not a proven strategy to answer the questions about large-scale commercial manufacturing. The developers of these processes are taking different strategies for commercial manufacturing as they weigh several factors.

3. Facility Design & Construction Tips For Up-Start Biotech Companies 1/4/2021

   Fledgling biotech companies are financially fragile, and they can ultimately become controlled by demanding fund managers. Those who manage facility engineering, design, and construction for these companies must adjust their thinking and employ some new tactics to document all costs and impacts, reduce schedule, and maintain quality.

4. Buyer Beware! Pharmaceutical Equipment Suppliers, Promises, & Delivery 9/30/2020

   Our industry depends on a wide spectrum of equipment suppliers that provide our manufacturing systems, utility systems, and environmental systems. This article raises a number of points to discuss with equipment suppliers and your facility engineers to plan for and assure a successful and compliant installation.

5. Repurposing An Aging Facility To Produce Cell & Gene Therapies 8/24/2020

   Many life sciences companies are shifting their operations to encompass new life-saving cell and gene therapy products, also known as advanced therapy medicinal products. In many cases, this requires converting legacy manufacturing facilities to produce these new therapies.

6. Repurposing A Facility For Cell & Gene Therapies: Demo & Engineering 7/30/2020

   Cell therapy capacity is in high demand, real estate and property are generally available at sites around the world, and the tendency is to place cell therapy production in an existing site. The challenge is to make the renovated space a successful GMP facility by engineering and building it correctly within the confines of the space and utilities.

7. Cleaning Up The Systems Mess: A Phased Approach To Implementing Real Automation And EBRS 5/20/2020

   The biopharma industry uses the most sophisticated microbiological and genomic technology, and we experience waves of advancements in therapies driven by our computing and communications technology. So, why are we still drowning in 100-page paper batch records, books of SOPs on the plant floor, and paper documents being handled by operators?

8. Isolators For Cell Therapy Manufacturing: Considerations & Challenges 4/16/2020

   As cell therapies move toward commercial production through scale up and multiple capacity increases, we as an industry have not come to grips with how to reliably and economically provide the needed capacity within the open manual processes that we have been working with for many years.

9. Another "Partnership" Sob Story: A Dear John Letter To Biotech Landlords 2/26/2020

   The “courtship” of a biotech tenant and a landlord often takes months, with negotiations over lease length and costs. Initially, the “romance” expects that the two parties will exist together for the long term; however, that is rare. Here's how to break off negotiations on the proposed lease and pursue other properties.

10. Valentine's Day Heartbreak: How To Let Your (Underperforming) CMO Partner Go 2/12/2020

    We read many articles about building relationships in the business environment to improve transactions, fortify the supply chain, and increase profits. But, what if the CMO has a deteriorating plant that directly impacts your production, or personnel turnover creates an environment of never-ending deviations and senseless retraining?