SKOKIE, Ill.--(EON: Enhanced Online News)--Vetter, a leading international contract development and manufacturing organization (CDMO) that specializes in aseptic filling for its (bio-)pharmaceutical customers, has announced today that its new clinical syringe line has already manufactured for its customers a double digit number of batches for use in early clinical trials. The line is part of growth expansion activities that have been undertaken at its Skokie facility to help satisfy growing customer demand. It also includes an increase in storage that is designed to help manage the continued growth in syringe fills and overall larger batch sizes.
“Year to date, a double digit number of clinical batches have been manufactured for customers and we anticipate a significant increase in the number of batches in the coming years”
Since beginning full operations in late 2011, Vetter’s clinical manufacturing facility located at the Illinois Science + Technology Park in suburban Chicago has been expanding to meet growing customer demands. Recently, this included six new chest freezers, two upright freezers and two refrigerator units. As a result, storage will be expanded by the end of the year to increase capacity by 150 percent. Combined with the new syringe line, these activities will help manage the increase the CDMO is experiencing in syringe projects for early clinical stages and in overall larger batch sizes.
In addition to the many clinical batches filled for customers in vials – both for aseptic liquid and lyophilized products – the solution provider has successfully launched an aseptic syringe filling line. "Year to date, a double digit number of clinical batches have been manufactured for customers and we anticipate a significant increase in the number of batches in the coming years”, explains Dr. Susanne Resatz, President of Vetter Development Services USA. This reflects the trend the company sees through its continuous dialogue with new and existing customers, as starting syringe work in the early clinical phases can cut up to 18 months off time-to-market. “Given our experience at this facility with filling and lyophilization, many of our customers are returning for development work for a second, third, or even fourth molecule. As a result of this, our outlook for future performance is very positive as demonstrated by a solid pipeline filled with high quality customer projects for biologics", Dr. Resatz adds.
Vetter’s Skokie facility is the company’s US clinical manufacturing site, providing development support for preclinical through phase II injectables, primarily complex biologics. The facility, currently operating with a growing staff of more than 60, has solid experience with a variety of complex compounds, and has already made more than five transfers to the company’s European commercial facilities to prepare for commercial launch, with more to follow in the near future. The site offers all the resources needed for efficient early-stage clinical manufacturing, including chemical analysis and microbiology labs, material preparation and compounding functions. At the heart of the facility are its cleanrooms, followed by visual inspection capabilities and GMP storage. The facility has collaborated with (bio-)pharmaceutical companies from various continents including the US, Europe, Asia, and the Middle East.
Operations in the company’s dedicated clinical syringe filling line at Vetter Development Services USA, Inc. in Skokie near Chicago.
Vetter is a global leader in the fill and finish of aseptically prefilled syringe systems, cartridges and vials. Headquartered in Ravensburg, Germany, the company operates production facilities in Germany and the United States, as well as sales offices in Singapore and Tokyo, Japan. The contract development and manufacturing organization (CDMO) is an innovative solution provider serving small, midsize, and the top 10 (bio-)pharmaceutical companies. Its portfolio spans state-of-the-art manufacturing from early clinical development through commercial filling and final packaging of parenteral drugs. Known for quality, the company of approximately 3,900 employees offers a foundation of experience spanning more than 35 years, including dozens of customer product approvals for novel compounds. More than 70% of Vetter’s active projects are biologics, and Vetter currently manufactures five of the world’ top 10. The CDMO is also committed to patient safety and compliance with user friendly solutions such as Vetter-Ject®, as well as its dual-chamber syringe Vetter Lyo-Ject® and cartridge system V-LK®. Visit www.vetter-pharma.com.