Vetter, a leading contract development and manufacturing organization (CDMO) that specializes in aseptic filling, has announced today that a number of activities undertaken at its Skokie facility to satisfy existing and ever-increasing future customer demands have been completed. The initiatives include an additional staff shift for daily clinical manufacturing operations, as well as the doubling of capacities for performing visual inspection and in-process control (IPC). The facility also expanded its on-site offerings by giving customers the option to obtain secondary packaging services for small batches of frozen drug products such as vial labeling, cartoning, and carton labeling. Furthermore, the long-term collaboration with Sentry BioPharma Services, a provider of cGMP clinical packaging solutions and supply chain management, supports a streamlined path from filling to clinic.
Responding to Customer Demand
‚ÄúWe are extremely pleased with our past years performance at the Skokie facility, as well as our overall success to date,‚ÄĚ said Vetter managing director, Peter Soelkner. The site, located at the Illinois Science + Technology Park in suburban Chicago has successfully passed audits and qualifications by as many as 30 companies, including nine of the top 20 leading pharmaceutical and biopharmaceutical companies. This performance has resulted in a wide-ranging customer base that includes not only those in the US, but also European companies based for example in the UK and Denmark, as well as Asian headquartered companies such as in South Korea.
‚ÄúMany of our customers have already returned for development work for a second, third, or even fourth molecule,‚ÄĚ added Dr. Susanne Resatz, president of Vetter Development Services USA, Inc. who is responsible for heading up the operation. ‚ÄúFurthermore, our outlook for future performance is very positive as demonstrated by a pipeline filled with high quality customer projects for biologics.‚ÄĚ Drugs under development by Vetter‚Äôs customers include treatments for blood cancer, muscular dystrophy, wound healing, and dwarfism.
Consistency in Filling Lines, Processes, and Quality Systems
As a CDMO, Vetter offers manufacturing resources starting from early drug development through to market launch and commercial supply. If desired, customers can not only get a ‚Äėmodular service‚Äô offering, but also a seamless transfer approach for their drug product from Vetter‚Äôs US early-stage facility to one of its European development and commercial manufacturing facilities. The sites on both continents use similar equipment and processes whenever possible, including product contact materials such as excipients and primary packaging materials. This flexible approach results in less overall risk of unforeseen manufacturing issues, and creates a consistency between clinical and commercial drug product handling.
In addition, the core of the aseptic manufacturing process (the filling lines) are designed in the same manner at Vetter‚Äôs clinical and commercial sites. The Chicago facility, designed specifically for high yield and flexible use, employs scaled-down versions of the company‚Äôs commercial filling lines. This aligned facilities approach reduces time and means less development work will be necessary to realize the transfer and scale-up process of the individual customer drug product.
Furthermore, all Vetter sites in US and Europe are part of the same company-wide quality system, offering a consistent quality approach over a project lifetime and avoiding non-productive time to adapt to new systems. The interaction of Vetter teams from both the US and Europe allows customers to access global expertise as necessary, an attribute that is especially valuable for projects with a very high level of complexity.
To date, four customer products in development have already been successfully transferred from Vetter‚Äôs US clinical manufacturing facility to the company‚Äôs European sites for manufacturing of late-stage clinical supply and for subsequent commercial production. The company plans for additional product transfers from the US to Europe in the near future.