Contract Manufacturing: Orchestrating the Dance
Lean Six Sigma, expertise in microbiology, and shop-floor experience all contribute to running a flexible, efficient contract facility, says DPTís new director of sterile ops.
By Paul Thomas, Senior Editor
Earlier this year, Michael Curry joined DPT Laboratories as its Director of Sterile Operations at the company's Center of Excellence for Sterile & Specialty Products in Lakewood, New Jersey. In this position, Curry manages manufacturing operations for nasal products, small volume parenterals and other sterile and specialty products, and for all aspects of aseptic manufacturing
Curry’s background is intriguing. He’s a Lean Six Sigma Green Belt who has worked with The Medicines Company, Dendreon Corp., Wyeth Pharmaceuticals, Baxter Bioscience, and Schering-Plough in a variety of roles. He is also former Director of Field Applications for BioVigilant Systems (Tucson, Ariz.), which specializes in rapid microbiological methods (RMM’s) for pharmaceutical applications. Curry has an M.S. in Microbiology from Seton Hall University.
We spoke with Curry about his experiences and ambitions:
PhM: Your background is extremely varied (in microbiology, Lean Six Sigma, regulatory, etc.). Is this kind of diversity really a prerequisite these days for a director of sterile operations or someone in a similar position?
M.C.: Is it a prerequisite? Probably not. Is it helpful? Extremely. I’ve been in the industry over 18 years now, and I started out in operations. They gave me a nice title because I had a bachelor’s degree in biology, but essentially I was an operator, and that was the best thing for my experience because I was on the floor, making batches, and really got a good experience as to what goes into making products, and I was fortunate to be working on an aseptic product as well.
I was also able to move around in different roles, with different companies, and that sure broadened my experience and understanding of not only how to make an aseptic product, but the whole process of developing it, making it, and manufacturing it commercially in a GMP way.
PhM: Was learning Lean Six Sigma something you did consciously from a career perspective, and is that something you apply in everything you do at DPT?
M.C.: Absolutely. If I was to define Lean Six Sigma, it’s really all about quality. It’s about first time right, and reduced waste, which is work that’s not done well or needs to be redone. What we’re implementing here are detailed records that allow our operators and compounders to execute flawlessly each time out. We’re taking away the opportunity for error, doing what I call mistake-proofing. For Example: making an inlet and an outlet hose connection different does not allow someone to hook up the hose lines incorrectly. Since my outlet is a different shape than my inlet, we can prevent someone from making a mistake in hooking up the lines. That’s really what Lean Six Sigma is, reduced errors, and less mistakes—first time right.
PhM: What work is going on in the Centre of Excellence for Sterile & Specialty Products? Can you share a few key projects that are ongoing, and any partners (clients, OEM’s, etc.) that might be involved? What kinds of things are on your agenda, as the new head of the centre?
M.C.: We want to be viewed by the industry, not just in the U.S. but in Europe and other countries, as DPT’s center for excellence for sterile and specialty products. We’ve established the small-volume parenteral capabilities that we’re looking to expand in Lakewood, and we’ve also validated syringe, nasal spray, ointment and tube-filling technologies, as well as multi-dose technologies. So we do have a broad spectrum of expertise here, and it’s a matter of continually improving and getting better at making these products, if not in an aseptic cleanroom, then in a cleanroom that complies with regulations and specifications globally, as opposed to just the U.S.
PhM: So the work that you’re doing will be applied globally at all DPT facilities?
M.C.: That’s correct. We may be working on a product for a client in which they’re trying to get an NDA approved, knowing full well that the client is thinking about filing in Europe. When we’re at the development and validation stage, we’ll bring that into the process. There are subtle differences between Europe and the U.S. where they consider a vial to be sealed, basically. We’ve already built in the full gamut of making sure that the crimping process is performed in a class 100 environment, so we know that we’re ready for the FDA and we know we’ll comply with European regulations.
PhM: When you started your job, what were the two or three things that you saw that were opportunities to make a difference right away?
M.C.: A few things right off the top that we wanted to do was to understand that the aseptic business is much different than the non-aseptic business, and it requires a little more of a dedicated headcount and staffing that will work in a particular area or zone so that things are done very well all the time. It’s not easy to move people around all the time as you would for, say, a secondary packaging operation that has a little more flexibility and leniency. When you’re in that aseptic area, the way you work, the cleanliness of your work, and the control that you need to demonstrate is of the utmost importance. That’s one thing that we’re building—small teams and groups of people that can not only work in those areas but take ownership and demonstrate their expertise over and over again.
We’re also bringing more detail into our records—taking the detail that was typically found in standard operating procedures and bringing that into the actual manufacturing records so that there is no ambiguity as you need to execute a step or a task.