Graz, Austria

Specializing in complex products and processes, the team at Graz has the ambition to always be on top of the latest developments and technologies. The commitment to innovation is not only reflected in the optimization and development of existing processes but also in the insourcing of new technologies such as ultrafiltration and distillation for the purification of raw materials, as well as the continued expansion of the product and container portfolio, currently with the implementation of syringe-filling. The plant in Wilson is specialized in the formulation, syringe filling, and packaging of aseptic and terminally sterilized drug products and diluents with the advantage of being able to offer large-scale quantities and flexibility in the syringe portfolio and sizes. PFS drug products and diluents are produced on fully automated manufacturing, inspection, and packaging lines in a continuous process under controlled conditions. This highly automated and state-of-the-art manufacturing facility, half of which is dedicated to prefilled syringe production, has a unique capability and capacity to launch hundreds of millions of new and existing commercial PFS drug products including biologics, highly active compounds and products (maximum OEL = 0.1 µg/m3), and products that are sensitive to temperature, light, and/or oxygen.

Constructed in 1977 and extended year by year, the plant in Graz has grown to a state-of-the-art manufacturing unit for sterile pharmaceutical solutions and emulsions. Operating in compliance with national, European and US-GMP regulations and with an export rate of more than 90%, the site supplies domestic and international markets, and acts as a reliable contract manufacturing partner. The site in Graz has built up a broad customer base over the years – strengthened by a range of support services, such as a GMP pilot plant for up-scaling and clinical trials batches, as well as excellent analytical and regulatory affairs departments. Top-tier pharmaceutical multinationals, regionally active pharmaceutical corporations, start-ups and biotech companies have entrusted the site with manufacturing of their sterile products.