Use of disposables saves time to clinic

The facility uses exclusively disposable components in material preparation, compounding and filtration areas, which eliminates the need for cleaning validation – and thus saves valuable time and cost. A third cleanroom will expand current operations and provide filling of pre-sterilized syringes.

Focused customer service, global business strategy

Said Vetter Managing Director Peter Soelkner, “Our Chicago facility provides customers with a top-of-the-line clinical manufacturing site located in the heart of the United States. Because Vetter consistently strives to stay at the forefront of innovation, securing Bosch’s new fully automated vial filler was a natural for us. Here in Chicago, our state-of-the-art systems and infrastructure, coupled with our professional expertise, offer customers the quality they expect from Vetter.“

Vetter’s Chicago facility is an expansion of Vetter Development Service, which employs more than 100 personnel in Europe and the United States. Strategic to Vetter’s plan for worldwide growth, the launch of Chicago operations highlights Vetter’s dedication to serving the North American market, where nearly half of Vetter’s client base resides.

Further demonstrating Vetter’s U.S. commitment is the company’s preferred partnership agreement with Midwest-based Sentry BioPharma Services, signed last year. From its site in Indianapolis, Indiana, Sentry is able to label, package and ship clinical supplies filled by Vetter, upon customer request. The collaboration will help streamline the path of study drugs from filling suite to clinic while safeguarding product integrity.

As with all Vetter facilities, the Chicago site and and its processes meet stringent FDA and EMA quality requirements. Adjunct services include regulatory counsel and product lifecycle management. Experienced project managers steer all product development projects, so that projects can stay on track, quality standards can be maintained, and deliverables can be met on time and on budget. The Chicago facility provides seamless product transfer to Vetter’s large-scale manufacturing facilities in Europe for Phase III and commercial manufacturing.