CoP Leader Profiles: Erich H. Bozenhardt

Erich has been a member of ISPE since 2005. He is Chair of the ATMP Community of Practice (CoP) Steering Committee and has volunteered on many ISPE Guidance Documents teams, including those for the ISPE Guide: Advanced Therapy Medicinal Products (ATMPs) – Autologous Cell Therapy and the ISPE Baseline® Guide: Biopharmaceutical Manufacturing Facilities. He is currently volunteering with teams producing ISPE Guidance Documents on risk-based validation of ATMPs, allogeneic cell therapy, and cell therapy equipment design.

Erich has been with United Therapeutics for three years and is responsible for all phases of manufacturing facility design and construction, implementing manufacturing technologies at GMP scale, and tech transfers. Since its inception, the company has strived to find a cure for pulmonary arterial hypertension and other life-threatening diseases. The company is also working to create an unlimited supply of manufactured organs for transplantation, including through xenotransplantation and 3D organ bio-printing technologies.

“We have multiple programs that are currently at the preclinical stage. This is a space where there is not a lot of industry precedent and I get to cycle between building a strategic framework and tactical execution. For both I’m learning from others and trying to develop new solutions. We’re trying to manufacture organs, so this is not something where we can use normal process equipment. I work with our R&D team to understand what they need and then determine how we can bring our technology into GMP manufacturing.”

Erich was always interested in biology and building things. He says that pharmaceutical engineering was the perfect field to combine both interests. He knew he had made the right career choice after working on a project developing a CAR T cell therapy for people with relapsed myeloma: a diagnosis that often means the patient will not live for more than six months. “We were able to go lightning fast from project concept to completion. We finished in about 11 months instead of the projected timeline of 16 to 18 months.”

“A few months after we finished the project, I was talking to the client, and they told me they had already dosed several patients and had a response rate of greater than 90%. I realized that because we were able to complete the project sooner than anticipated, they were able to treat a whole cohort of patients who otherwise might not be alive. That day I was able to realize the impact that I can have on patients’ lives just by being an engineer. It really strengthened my passion, which I carry forward with me into the work that I’m doing with United Therapeutics.”

“There are a lot of people developing truly unique solutions for ATMPs, but there’s no industry best practice yet. It seems like every couple of months, there’s something new coming out—some new variation and the ATMP CoP is a great opportunity to come together to discuss different challenges and solutions.”

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