Rx for drug manufacture: Safety + efficiency
Stull: The FDA evaluates us against good manufacturing practices or GMPs. A key challenge is keeping up with these guidelines, which are constantly evolving. We do sterile manufacturing, which requires controlling the environment in which we produce the pharmaceuticals to eliminate contamination. Product containers are filled under Class 100 clean room conditions, and process control equipment monitors such factors as differential pressures in the air that could affect product quality. Documentation is particularly important, because that is what the FDA reviews. In addition, because we are an international company, we must meet the standards of regulatory bodies around the world.
WBJ: What pharmaceuticals do you produce in Westboro?
Stull: We still produce local anesthetics, which was the first product that our company started with in Massachusetts. But we also have expanded into asthma drugs, drugs for nasal allergies and, more recently, an intravenous version of our Nexium™ gastrointestinal drug.
WBJ: How many people do you employ, and are there plans for expansion?
Stull: Our manufacturing operation employs about 700 people. Also on campus is the Northeast Business Center, which directs our sales organization in this region. We are getting ready to open an expanded microbiology laboratory. This facility tests samples of pharmaceuticals that we produce, as well as conditions in the manufacturing environment. We’ve hired some new microbiology technicians for that lab, but workforce expansion is really not our key focus now. Our big challenge is how to operate the supply chain at AstraZeneca within a global context.
WBJ: What does that challenge represent for manufacturing?
Stull: It means introducing principles of Lean manufacturing, used so effectively in other industries. We need to build more flexibility into our equipment, as well as in the skills of our people, so we can respond faster to the needs of the marketplace. This is going to be a big priority for us over the next couple years. One organization that we are reaching out to is the Massachusetts Manufacturing Extension Partnership, which helps companies become more competitive in their production systems. We also need to hire and train employees who are able to operate increasingly complex equipment, as well as analyze and deploy more sophisticated data analysis on the production line.
WBJ: What other AstraZeneca operations are in Massachusetts?
Stull: The company has a big footprint in this state. In Waltham, we operate an R&D facility, employing about 450 people, that does basic research into oncology and infectious diseases. In total, AstraZeneca employs nearly 1,500 people in Massachusetts, out of its total U.S. workforce of about 12,000. Overall, the company, headquartered in London, employs over 65,000 people worldwide. We have some 14,000 people at 27 manufacturing sites in 19 countries dedicated to ensuring we can deliver a secure, high quality, cost-effective supply of our product range around the world. Our company mission is to develop innovative medicines in such therapeutic areas as cardiovascular, central nervous system, pain and infection, respiratory, oncology and gastrointestinal.
WBJ: AstraZeneca recently received the CEO Cancer Gold Standard Accreditation. How does that program work?
Stull: Our CEO, David Brennan, served on the roundtable of CEOs who developed this standard, which requires that companies evaluate their benefits structure and corporate culture to prevent cancer or to detect it as early as possible. Here at Westboro, we ban all tobacco use everywhere on campus. We have an onsite fitness center with personal trainers who run classes and work with people individually. In our cafeteria, we offer healthy options at lunch and include healthy snacks in vending machines. Throughout the year, we hold onsite screenings, such as breast exams, prostate tests, cholesterol and blood pressure, and skin cancer screenings. If cancer is detected, we want to make sure that employees have access to the best treatment centers, including access to clinical trials for promising new cancer drugs. We also ask each employee to fill out an annual health risk assessment, conducted through the Mayo Clinic. Not only do they receive counseling on risk areas, but they also save $50 a month on health insurance payments. This makes perfect sense. As a pharmaceutical company, we should live in the manner that we are encouraging other folks to live.
This interview was conducted and edited for length by WBJ Chief Editor Larry Maloney.
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