RAVENSBURG, Germany—Vetter, a leading global contract development and manufacturing organization (CDMO) for development, aseptic filling and final packaging of injectables, has announced that it has begun operations in its expanded Visual Inspection and Logistics Center located in Ravensburg. The enlargement, in which the company invested approximately €100 million ($107 million), bundles capacity for final product inspection and logistics in one site.
According to Vetter Managing Director Thomas Otto, the decision to move from the Holbeinstrasse site to the new Ravensburg Vetter West was “based on the target in mind to establish a single central warehouse and logistics services. In addition, this means we can also bundle the capacity for final product inspection in one cutting-edge site. Recently, Vetter finalized the second construction stage of the site. The groundbreaking for this expansion took place back in 2014. The initial site (the first construction stage) was put into operation in 2012.”
By finalizing the second construction stage of the site that was initially put into operation five years ago, the CDMO now offers more than double the capacity for state-of-the-art quality control, cold-storage and room-temperature storage. Given the increasing industry-specific requirements emanating from customer and regulatory side, the company now provides even more efficient and flexible supply chain processes.
The expanded center, referred to as Ravensburg Vetter West, is located on approximately 50,000 square meters (538,000 square feet) of floor space and offers a 35,000-pallet warehouse capacity for storing pharmaceuticals in refrigeration or room-temperature conditions. The capacities for chest freezers, incubation chambers and constant climate chambers have also been increased, as have the visual inspection capacities of filled units which can be realized in either manual or automatic mode. This allows Vetter to react with greater flexibility to individual market and customer needs.
The center also contains a support materials warehouse with corresponding safety installations as well as a new packaging-check laboratory and the company’s central archive. Additionally, the number of office workspaces were increased. By the end of 2017, the CDMO will relinquish its existing Holbeinstrasse site for visual inspection and logistics. Its employees and departments will gradually be relocated to Ravensburg Vetter West, resulting in a working staff of approximately 800 employees.
“Quality, reliable delivery and efficient logistics play an increasingly important role in the highly competitive drug market. Vetter supports many of the world’s key drug manufacturers in the development and manufacturing of their products. The recent enlargement bundles capacity for final product inspection and logistics in one cutting-edge site. Concentrating our supply chain processes in one site enables bundled resources for even more efficient and highly secured logistic and quality control procedures,” Otto tells DDNews. “The enlargement also creates a couple of benefits, including the ability to offer more than double the capacity for state-of-the-art quality control, cold-storage and room-temperature storage. Furthermore, given the increasing industry-specific requirements emanating from customer and regulatory sides, Vetter can now provide even more efficient and flexible supply chain processes.”
2016 was again a successful year for Vetter. The demand of international customers in the areas of clinical development, commercial production and final packaging continued to increase. The CDMO supported its customers with drug product manufacturing, including five of the world’s top 10 biologics. Overall, the number of Vetter employees operating in its production sites and sales subsidiaries in Germany, the United States and Asia increased from 3,600 employees to approximately 4,100.
In addition to opening Ravensburg Vetter West, Vetter is also busy constructing a new building on the same site. Otto says, “The construction of a new production building is taking place at Vetter’s existing Ravensburg Schuetzenstrasse site. Scheduled for completion in the first quarter of 2018, the building is planned to begin operations in early 2019. It is expected to cost approximately €70 million (about $75 million).”
As we had noted previously in DDNews, 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.
“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 told 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.”
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,” Otto says.