Robust rebuilding

Projecting a cost of about €70 million (about $79 million), Vetter described the building as “part of the total investment strategy announced in September 2015” and “an important element in the overall Schuetzenstrasse facility rebuilding concept for modernization and expansion.” Vetter, a contract development and manufacturing organization (CDMO) for the development, commercial manufacturing and final packaging of aseptically prefilled drug-delivery systems, plans to invest about €300 million to expand and upgrade its manufacturing facilities over an estimated five-year period.

“We are continuously monitoring and reacting to a changing marketplace and are pleased that we are in the position to be able to make these strategic investments to further develop our sites and meet these challenges,” Vetter Managing Director Peter Soelkner tells DDNews. “Individually and collectively, they will help us keep pace with the market and allow us to continue to build a successful future for Vetter and our customers.”

Other Vetter facility expansions are already ongoing at several of the company’s German locations, including its Ravensburg Vetter West center for visual inspection and logistics. Structural work for the facility enlargement, which will offer more than double of its current capacity, is completed, and the site is expected to become fully operational in 2017. In addition, the Ravensburg Vetter South production site has also been designated for significant enlargements as is the Ravensburg Schuetzenstrasse facility where initial construction activities began in 2013. All three site expansions will result in additional capacities for drug product manufacturing and logistic services.

Thomas Otto, also a Vetter managing director, says that the CDMO is “continuously developing its manufacturing sites and techniques to prepare them for future needs and requirements.” The upgrades are “being driven by a changing healthcare market that is affected by issues such as ever-more complex molecules, smaller batch sizes and increasing regulatory requirements,” he adds.

When finished, the seven-story Ravensburg Schuetzenstrasse building will cover a total of 8,000 square meters (86,000 square feet) and include a cleanroom with supportive media systems. In addition, it will contain the site’s central material preparation, office space for the production staff and a staff canteen with roof garden.

The applied technology of the cleanroom will be “dedicated to the filling of bulk syringes and designed to be compatible for the filling of sensitive drugs such as biologics and opthalmics,” Otto explains, adding that syringes prepared in the bulk process offer a number of customization options that are tailored to substance and primary packaging material components. They offer customizable low silicone levels and, thus, process flexibility.

Another key technological aspect of the cleanroom will be the implementation of an improved restricted access barrier system (RABS) concept to combine the advantages of isolator and RABS technology. For decades, Vetter has relied on RABS as one of the two distinct technologies available today for its aseptic filling processes, the other being isolators. RABS achieves the sterility assurance level required by regulatory authorities, and allows for rapid product change-over coupled with high safety. To better meet future industry trends in quality, safety and flexibility, a corporate project team has evolved this “improved RABS concept” by combining the advantages of isolator and RABS technology.

“The core of this innovative approach is a uniquely fast, by today’s standards—a three-hour cycle and fully automated decontamination of the cleanroom using hydrogen peroxide (H₂O₂),” Otto says.

Vetter works with the top 10 biopharmaceutical companies, as well as small and midsize companies, on state-of-the-art manufacturing from early clinical development through commercial filling and final packaging of parenteral drugs. The company covers a broad range of complex compounds including monoclonal antibodies, peptides and interferons.

“This addition to our Schuetzenstrasse site is an exciting chapter in our company’s history and will again support Vetter’s target to offer its customers high manufacturing quality for their high-value drugs,” noted Otto in the news release about the expansion. “Attaining this high level of quality is of particular significance to Vetter.”