Vetter, a leading contract development and manufacturing organization that specializes in aseptic filling, today announced that its first U.S. facility is now fully operational. Located at the Illinois Science + Technology Park in suburban Chicago, the 24,000-square-foot site includes microbiology and chemical analysis labs, material preparation and compounding functions, three cleanrooms for aseptic filling, and visual inspection. The first to use Bosch’s new MHI 2020 B fully automated vial filler, Vetter’s Chicago facility offers state-of-the-art technology and processes to support preclinical through Phase II compounds.
Designed specifically for early clinical-stage, high-value biopharmaceuticals, Vetter’s new automated vial filler can run up to 10,000 liquid or 6,000 lyophilized vials per batch.
Intended for liquid fills, a second cleanroom houses a flexible semi-automated filler. The system can fill a variety of packaging materials – syringes, cartridges and vials – with a capacity of up to 500 units per batch.Both automated and semi-automated units provide a 100 percent in-line check-weigh system, which helps ensure accurate fill volume – critical in small, early-stage fills. Because no sampling is required to verify fill volume, the system increases API yield.
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.
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.