Vetter
Specialist in aseptic filling Vetter has announced completion of a number of activities undertaken at its Skokie facility in Chicago to satisfy existing and ever-increasing future customer demands.
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 labelling, cartoning, and carton labelling. 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.
The site, located at the Illinois Science + Technology Park, has successfully passed audits and qualifications by as many as 30 companies, including 9 of the top 20 leading (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.
“Many of our customers have already returned for development work for a second, third or even fourth molecule,” said Dr. Susanne Resatz, president of Vetter Development Services USA, who is responsible for heading up the operation. “Furthermore, our outlook for future performance is very positive, as demonstrated by a pipeline filled with high-quality customer projects for biologics.” Drugs under development by Vetter’s customers include treatments for blood cancer, muscular dystrophy, wound healing and dwarfism.
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 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, i.e. the filling lines themselves, is 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 realise the transfer and scale-up process of the individual customer drug product.
To date, four customer products in development have already been successfully transferred from Vetter’s US clinical manufacturing facility to the company’s 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.