Vetter, a leading contract development and manufacturing organization (CDMO) that specializes in aseptic filling, announced that a number of activities undertaken at its Skokie, IL 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.
“We are extremely pleased with our past years performance at the Skokie facility, as well as our overall success to date,” 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 (bio)pharmaceutical 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.
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 ‘modular service’ offering, but also a seamless transfer approach for their drug product from Vetter’s U.S. 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 i.e., the filling lines themselves are designed in the same manner at Vetter’s clinical and commercial sites. The Chicago facility, designed specifically for high yield and flexible use, employs scaled-down versions of the company’s 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.