Interview with James Dean Vogel, a licensed Professional Engineer with more than 25 years' experience in biochemical engineering. Vogel has worked as a director, project manager and engineer with Amgen, GlaxoSmithKline and ImClone among others, and is an Adjunct Professor at Stevens Institute of Technology. He founded the BioProcess Institute, which tests bioprocess components and offers consulting to a broad range of manufacturers and their suppliers in the biopharmaceutical, pharmaceutical, food and cosmetics industries. Vogel is a member of NAHAD's Hose Safety Institute Advisory Council.
NAHAD: Tell me a little about your background and how you got involved with biochemical engineering.
Vogel: It was early in my career that the whole idea of biochemical engineering really hit me. I was good at science in high school, and I then went to Rutgers University, where they had one of the first accredited biochemical engineering programs. During my freshman year, we took introductory classes in different areas of engineering, like civil, mechanical and so on, and within minutes of my introduction to biochemical engineering, I knew that was what I wanted to do.
The whole idea of cells and biological systems as little factories to make a product was, to me, the ultimate challenge, not to mention the benefits I found later on as I got more involved with medicine in helping people treat horrendous diseases with novel therapies.
I also brew my own beer as a hobby. When you think about that and compare it to how these drugs are made, while it's very expensive media being used to produce the drugs, it's actually more or less the very same process of making beer.
NAHAD: Considering your experience with some of the companies in your career, you must have worked on some pretty fascinating projects. Can you tell me about one that stands out in your mind?
Vogel: There are many, but here are two extremes.
Early in my career I worked with Lipton Tea. We wanted to make an instant tea that tasted like tea from a tea bag. We worked on creating and streamlining a biological process to make the product using enzyme technologies and reverse osmosis and other novel technologies that are also used in human therapeutics. It was a prototype that unfortunately never went forward, but that was quite an interesting project. We did, later on, bring a lot of what we learned there to the large-scale production plant to improve production and quality.
The other example is in pharmaceuticals, when I led the design of a large plant to make the product Enbrel, which treats arthritis. At the time, it was in very short supply, and there was actually a lottery for folks trying to get it. I led a team of engineers to design and direct the building of that plant, which cost hundreds of millions of dollars. It's now a very productive plant, and many of the folks that I brought into the plant are still there in leadership positions.
NAHAD: Tell me about your work with the BioProcess Institute. Why did you found the institute, and what projects have you been focusing on recently?
Vogel: We do third-party independent testing to look at the performance of components in the bioprocess industry. We also do consulting to help people solve problems with their processes. The ability to clean and freely drain, so as not to retain process fluids, is key for the bioprocess industry. This helps ensure the production of pure products, and ultimately patient safety in the case of making biopharmaceuticals. We test hoses as well as other components, and we evaluate them for how they perform, whether to investigate a failure or to look at process performance, service life or when it will require maintenance.
We recently looked at the cleanability of hoses in the different configurations that they're installed and how that affects the ability to remove soil in them, and we found some interesting things. We found that cleanability was actually more dependent on how the hose was mounted in the fixture than other factors we suspected would be more critical. We also recently did thermal cycling of hoses and learned that autoclaving put significantly more wear on them than steaming in place.
NAHAD: How did you get involved with NAHAD and the Hose Safety Institute Advisory Council, and how has your background helped you to contribute to Council goals?
Vogel: Ernie Pitchford at Parker Hannifin and I are on the ASME BioProcessing Equipment (BPE) standards committee, and he suggested that my experience may be beneficial on the Council and introduced me to NAHAD.
As someone with experience in the bioprocess area, I believe I bring that experience and that diversity to the group. I'm able to bring what I've learned about hose design and application to the community through my association with the Council, something I think is needed more and more. I'm involved with other organizations' standards, but I really see the Hose Safety Institute as just the right mix of people who really understand the function of the components.
NAHAD: How do the NAHAD Hose Assembly Guidelines provide value within the manufacturing and distribution industry in general and within biological manufacturing in particular?
Vogel: The Guidelines provide a lot of value. It's a good reference for distributors, who don't always know how their hoses are applied. It also helps them give guidance to their clients who may also need help. The cleaning study is a good example, since I didn't have the Guidelines when I did that study, and we could have used them. We had the recommendations from the manufacturer, but they weren't as robust as what we now have in the Guidelines.
My experience is that most people don't install hoses properly. We've simulated those conditions in the lab and confirmed that if they're not installed properly, their function will be affected. Within biological manufacturing, like with other types of manufacturing, it comes back to the idea of application and having some specific guidelines for installations. Most biological people are not experts on hoses and not all vendors and distributors are experts in biological processes. This is a great resource for distributors wanting to give better advice to their end users who need that support.