In the pursuit of successful pharmaceutical enterprise, contemporary wisdom suggests that managing the complexities associated with critical preclinical developmental stages may be better left to operational experts outside one’s organization. Whatever the underlying business reason for seeking outside support, navigating a promising injectable through trial phases, then seeing it through to commercial-scale production requires intensive operational excellence to accomplish compliantly and successfully. The sky-high trajectory of biopharmaceutical development in the U.S. continues to prompt a steady and growing demand for services supporting injectables development — a promising and lucrative market that five years ago Vetter, headquartered in Germany, knew it could expand to meet, given the right operational footprint in North America.
RIGHT SPACE, RIGHT STRATEGY
In Vetter’s capabilities literature, its marketing team characterizes the company as a leader in aseptic contract filling. With more than 35 years successfully providing fill and finish services, formulation support, process development and packaging development services, Vetter’s claim of leadership is hard to dispute. The company delivers its service offerings to global customers via three primary business units: Vetter Commercial Manufacturing, Vetter Packaging Solutions and Vetter Development Service (VDS). With so many promising molecules and injectable therapies being developed out there, Vetter’s growth strategy began to focus on expanding VDS operations in the U.S.
After a thorough search process, the team — including Claudia Roth, VDS Chicago’s president — identified a promising site near Chicago. Roth explains that Vetter considered all of its options in its quest to secure lab and filling process capacity in the U.S., but quickly concluded that finding an established facility with the best combination of location, civic infrastructure, expansion potential and site-specific amenities would create the best basis for Vetter’s U.S. VDS operations. Although plenty of idle pharmaceutical capacity may be available, finding the appropriate site for VDS had its challenges, says Roth: “At that time there was not that much wet lab space available.” She says that ultimately, the former Searle campus in Skokie, Illinois, offered the best, most flexible site. The campus, now known as the Illinois Science and Technology Park (ISTP) offers tenants, according to ISTP’s website, “approximately 2 million square feet of office and state-of-the-art facilities including chemistry and biology labs, GMP and NMR facilities creating a full-service corporate research campus.” Vetter’s Skokie, Illinois, “neighborhood” is optimal in many respects. For instance, it’s a collar suburb of Chicago, has proximity to one of the nation’s biggest airports, and the geographically central region supports an ecosystem of Pharma-related businesses along with a skilled and experienced labor pool. “We liked it because of its ‘reachability,’” says Roth, noting the logistical benefits stemming from VDS’s location. “We can reach Chicago in a two- or four-hour flight from [the] coasts and we have only a seven-hour time difference from our parent company, so accessibility was good.”
Overall, Vetter’s facility encompasses about 30,000 square feet with roughly one-third dedicated to manufacturing; one-third to labs and the remaining third devoted to administration offices and warehouse space. “We had the chance to leverage the layout [because it was] a former pilot plant of Searle. But for sure, we had to fully retrofit it,” says Roth, “there was not a single piece of equipment that we could use.”
One example is the original water for injection generating system Searle installed. Even though it was still functioning it was 30 years old, says Roth, and “did not have the necessary documentation, e.g., material certificates to fully qualify the system to today’s GMP standards.”
So while the layout and location were optimal, says Roth, all new process equipment had to be installed. “We started in 2010 with the retrofitting of labs and clean rooms. We also installed new utilities and our own water-for-injection generating system.” Roth points out that they used the labs to qualify the new water-for-injection facility and get ready to install the clean rooms. “It was always planned from the very beginning that we do a step-wise implementation of clean rooms,” says Roth, pointing out that VDS Chicago has a total capacity of three filling lines: the first is a multipurpose line for liquid vials, syringes and cartridges VDS installed and commissioned in 2010. In 2011, a vial line with an adjacent freeze dryer was commissioned; and in spring 2014, Vetter was busy installing its third line for syringes, which primarily enables packaging flexibility and in-line check weighing for high throughput. As of this writing, the third clean room is currently in qualification.
Roth explains that whatever is needed for incoming materials in processing, final product testing, utility testing as well as environmental testing can be accomplished by VDS Chicago labs, including some limited stability testing for customers: “What I mean by ‘limited’ is that some customers have their own stability chambers, but they do not have all the methods necessary. So they store everything and send us the samples. We perform the analysis and send the results back. If a customer wants to leverage [Vetter’s] stability program, we outsource that to our parent company, which has all the ICH conditions and very large stability chambers.”