Issue: November/December 2016, Posted Date: 12/13/2016
Vetter's Skokie Site Successfully Manufactures Batches on New Clinical Syringe Filling Line
Vetter, a leading
international contract development and manufacturing organization (CDMO) that
specializes in aseptic filling for its (bio-)pharmaceutical customers, recently
announced 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.
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.
Operations in the company’s dedicated clinical syringe filling line
at Vetter Development Services USA, Inc. in Skokie near Chicago.
Source: Vetter Pharma International GmbH.
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
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.
Vetter Pharma International GmbH
Senior Vice President Key Account Management,
Marketing / Corporate Communications
Phone: +49 (0)751-3700-3706
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