Vetter has announced that in keeping with its commitment to providing customers with high quality drug products, the company will invest approximately €300 million to expand and upgrade its manufacturing facilities during an estimated 5-year period.
As a leading contract development and manufacturing organization, Vetter is continuously developing its manufacturing sites and techniques to prepare them for future needs and requirements. The upgrades are being driven by a changing healthcare market that is affected by issues such as ever-more complex molecules, smaller batch sizes, and increasing regulatory requirements.
The first of the facility expansions is already ongoing at several of the company’s German locations, including its Ravensburg Vetter West centre for visual inspection and logistics. Structural work for the facility enlargement, which will offer more than double of its current capacity, is completed, with the site being on schedule to become fully operational in 2017.
In addition, the Ravensburg Vetter South production site has also been designated for significant enlargements as is the Ravensburg Schuetzenstrasse facility where initial construction activities began in 2013. All three site expansions will result in additional capacities for drug product manufacturing and logistic sevices.
A central technology element of the planned upgrades will be the implementation of an in-house made improved restricted access barrier system (RABS) concept, which will contribute to increased operational excellence in aseptic manufacturing. For decades, Vetter has relied on RABS as one of the two distinct technologies available today for its aseptic filling processes, the other being isolators.
RABS achieves the sterility assurance level (SAL) required by regulatory authorities, and allows for rapid product changeover coupled with high levels of safety. To better meet future industry trends in quality, safety and flexibility, a corporate project team has evolved this ‘Improved RABS concept’ by combining the advantages of isolator and RABS technology.
The core of the approach is a uniquely fast, by today’s standards, 3-hour cycle and fully automated decontamination of the cleanroom using hydrogen peroxide (H2O2), resulting from an extremely high level of process innovation. Following a successful pilot project in a selected cleanroom, the company will now implement this decontamination concept in all of its cleanrooms within the next few years.
All of the planned activities are designed to meet future customer expectations and regulatory requirements at an early stage, maintaining a level of manufacturing excellence that customers have come to expect from Vetter. “We are continuously monitoring and reacting to a changing marketplace and are pleased that we are in the position to be able to make these strategic investments to further develop our sites and meet these challenges. Individually and collectively, they will help us keep pace with the market and allow us to continue to build a successful future for Vetter and our customers,” said Vetter’s Managing Director, Peter Soelkner.
Managing Director, Thomas Otto, added: “As trusted partners for drug product development and manufacturing, it is our intent to always get each customer’s job done right. To reach this level on a continuous basis, these investments are the right step, at the right time.”