Increasing clinical syringe fillings at the Vetter US location in Chicago

Overview of the aseptic clinical filling of syringe systems at the US site in Chicago. (Source: Vetter Pharma International GmbH)

Vetter, an internationally leading Contract Development and Manufacturing Organization (CDMO) in the field of aseptically pre-filled injection systems, has already produced clinical batches in the double digits for early clinical trials of its customers on its new syringe line at the US site in Chicago. The filling line is part of the continuous expansion of the site, driven by increasing customer demand. The current expansion also includes an increase in storage capacities. The company is thus preparing locally for the rising demand for pre-filled syringes in early clinical phases and for a generally larger batch requirement from its customers.

The Vetter site for clinical manufacturing in the Illinois Science + Technology Park near Chicago has been continuously expanded since its opening. Recently, in addition to the new filling line for syringes, six additional freezers and two new freezer cabinets and cooling units have been installed. By the end of the year, storage capacity is expected to increase by 150 percent. With the new filling line and the storage expansion, the pharmaceutical service provider is positioning itself to meet the increased demand for syringe fillings for early clinical phases and for generally larger batch sizes.

Since 2011, Vetter has been filling active ingredients in liquid and lyophilized form into vials in Chicago for customers. Its service offering for aseptic clinical active ingredient filling has been successfully expanded with a filling line for syringe projects. "Throughout this year, we have already produced a double-digit number of clinical batches for our customers – and we expect further growth in demand in the coming years," summarizes site manager Dr. Susanne Resatz. This reflects the development that Vetter observes through continuous dialogue with new and existing customers. The start of a syringe development in the early clinical phases can thus save up to 18 months on the way to market launch. "Many of our customers have already had good experiences with filling and lyophilization of their active ingredients at the Chicago site. That’s why they also trust our expertise when developing their second, third, or even fourth molecule. This makes us very optimistic about the future utilization of the site with numerous demanding customer products, especially from the biotechnology sector," adds Dr. Resatz.

Vetter’s manufacturing site in Chicago supports early clinical development of injectable drugs from preclinical to Phase II. The more than 60 experts at the site have extensive experience with a range of complex molecules. More than five projects have already been successfully transferred to the company's commercial production facilities in Europe for further development and commercialization. The portfolio of the US manufacturing site includes all functions needed for early clinical manufacturing. In addition to chemical and microbiological laboratories, these also include material preparation, an approach area, and the production lines themselves. After filling, optical inspection takes place. Storage capacities according to GMP standards are also available on-site. The US location of the pharmaceutical service provider supports a broad customer base, including pharmaceutical and biotech companies from the USA, Europe, Asia, and the Middle East.