Leveraging End-to-End Support
The manufacture of biologic drug products, particularly those that require aseptic processing, is quite complex and requires specialized expertise. Early and careful planning for the future can significantly contribute to the success of a development project. The involvement of an experienced solution provider with end-to-end capabilities contributes to the monetary value of drug substances and formulated products. These CDMOs can support drug candidates from the development phase through late development, market launch and subsequent commercial manufacturing, as well as lifecycle management activities, maximizing the value of the complete drug package.
Smaller and virtual biotech companies that lack the resources to focus on the complete drug package sometimes may fail to achieve optimized outcomes. Partnering with a trusted, full-service CDMO early in the process offers a greater likelihood of success. In addition, startups that pursue projects from the very start with the end goals (packaged final products) in mind often attract the financial assistance of large companies, relationships that can lead to out-licensing deals or even acquisitions.
For both small and large drug developers, using different outsourcing providers for different phases of the development and commercialization cycle can increase both cost and risk due to the need for technology transfer activities. In addition, with an end-to-end CDMO, knowledge gained during early development work is retained and can be applied during late-stage process development.
An Example of Vetter Innovation
At their core, aseptic processes and technologies are designed to minimize any contact between a drug product and the outside environment, thereby minimizing any chance for contamination. Historically, cleanrooms have employed either isolators or restricted access barrier systems (RABS). Isolators are generally considered to provide the highest level of sterility, but RABS offer greater flexibility and thus are suitable for realizing numerous filling projects in a single cleanroom. In response to changing market needs and to meet the competing demands for the highest levels of quality and flexibility in aseptic processing, Vetter has developed the Vetter CleanRoom Technology V-CRT®, an innovation that combines the advantages of isolators and RABS, bringing together the safety and quality standards of isolator performance with the flexibility offered by RABS. The company will implement this decontamination concept in all of its cleanrooms within the coming years.
Pillars of Service
Vetter has long-term experience offering services ranging from early development support including clinical manufacturing, to commercial supply and various packaging solutions — to small, midsize and large pharmaceutical and biotech companies. We specialize in the aseptic manufacturing of prefilled syringes, cartridges and vials and have experience with monoclonal antibodies, peptides, interferons, vaccines and other complex compounds. Our state-of-the-art technologies and innovative processes are able to improve product quality and maximize API yields.
Vetter Development Service partners with clients from preclinical development through Phase III, planning for commercial production from a product’s earliest stages. Services include formulation support, process development, clinical trial manufacturing and analytical and regulatory support. We develop processes that mirror those at our commercial production facilities, enabling seamless product transfer to Vetter Commercial Manufacturing, which provides Phase III manufacturing through to a global market supply.
At this level, Vetter offers a full range of services to deliver quality across the supply chain, including fill & finish, analytical services, regulatory support and product lifecycle management activities. These efforts are backed by measures taken both downstream and upstream to strengthen security of supply, including regular quality reviews of all suppliers and cross-linked IT systems to monitor manufacturing processes.
For final packaging, Vetter Packaging Solutions matches client products with appropriate drug-delivery systems (primary packaging); and provides secondary packaging, such as cartoning or blister packing, and other packaging services, including pen-system assembly, printing and labeling, and serialization. Our capabilities include customized packaging development, specialized technologies, platform technologies, and packaging and logistics services.
Clinical manufacturing is performed at a dedicated facility in Chicago, USA and in Ravensburg, Germany, where Vetter also operates three commercial facilities, a secondary packaging facility and a center for visual inspection and logistics.