German contract development and manufacturing organisation (CDMO) Vetter will invest approximately €300m to expand and upgrade its manufacturing facilities over a five-year period.
Vetter, which specialises in the fill and finish of aseptically prefilled syringes, says the upgrades are being driven by a changing healthcare market that is facing issues such as ever-more complex molecules, smaller batch sizes, and increasing regulatory requirements.
The first of the upgrades is already underway at several of the company’s German locations, including at its Ravensburg Vetter West centre for visual inspection and logistics. Structural work for the expansion, which will more than double current capacity, is completed and the site is on schedule to become fully operational by 2017. In addition, the Ravensburg Vetter South production site will be significantly expanded, as well as the Ravensburg Schuetzenstrasse facility where initial construction activities began in 2013.
All three site expansions will provide additional capacity for drug product manufacturing and logistics.
The expansions will help us keep pace with the market and allow us to continue to build a successful future
A central technology element of the planned upgrades will be the implementation of a restricted access barrier system (RABS) concept, developed in house, which the firm says will contribute to increased operational excellence in aseptic manufacturing.
For decades, the CDMO has relied on Restricted Access Barrier Systems (RABS) as one of the two distinct technologies available today for its aseptic filling processes; the other is isolators. RABS achieve the sterility assurance level (SAL) required by regulatory authorities, and allow for rapid product change-over coupled with high safety. To meet future industry trends in quality, safety and flexibility better, 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, three-hour cycle and fully automated decontamination of the cleanroom using hydrogen peroxide (H2O2), resulting from a 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 upgrades are designed to meet future customer expectations and regulatory requirements at an early stage, Vetter says.
'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,' said Vetter's Managing Director Peter Soelkner.
'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.'