Cytotoxics and cytostatics are in increased demand in the global pharmaceutical market. To meet this steadily increasing demand, Aenova, a leading development service provider and contract manufacturer for the pharmaceutical and healthcare industries, has built a new building at its Regensburg site for the development and production of highly effective active pharmaceutical ingredients (APIs). The total investment of around €25 million will enable the company to expand its production of highly potent active ingredients up to OEB 5 and, in particular, of cancer drugs. The new building was opened on June 22, 2023.

The Aenova site in Regensburg has been developing and producing tablets and capsules with highly potent active ingredients such as methotrexate, hydroxycarbamide, azathioprine, imatinib since the 1950s. These are, for example, drugs for the treatment of inflammatory diseases such as psiorasis or arthritis, against autoimmune diseases, drugs against cancer such as leukemia, but also novel drugs (so-called New Chemical Entities, NCE). The special feature of many of these drugs is their high efficacy, which means that the active ingredients already have the desired effect in the smallest doses, but special safety standards must therefore also be observed during development and production.

The new four-story building with a total building area of more than 4,000 square meters houses the production and packaging of highly potent tablets as well as the associated laboratories, development, storage, and social rooms. This means a significant expansion of the production area and the areas of development and laboratory by over 2,100 square meters at the Regensburg site.

After the planned start-up at the beginning of 2024, the production capacities can be increased in volume by significantly more than 1 billion tablets and capsules. An entire floor is reserved for flexible customer requests for “on demand” production, so that existing and new customers can be individually supported in line with their requests. The new building is part of the strategic profiling of the Regensburg site for the development and production of highly effective medicines. Around 400 people are employed at the Regensburg site.

The Regensburg site is “Competence Center HPAPI & Oncology Products” within the Aenova Group with leading HPAPI development, production, and packaging facilities for high-potent solids. “The new building is an important milestone for this,” said Oliver Schmied, managing director at the Aenova site in Regensburg. “Producing billions of tablets and capsules each year, Aenova is a partner of choice for novel product solutions as well as commercial high-volume manufacturing. A particularly unique selling point is that we offer production flexibility using harmonized production equipment, enabling small to large batches from 0.5 to 500kg for development, CTM, scale up and commercial batches.”

Jan Kengelbach, CEO of the Aenova Group, said, “Within the overall investments of the Aenova Group, the new building for highly potent APIs in Regensburg is an essential strategic building block. As a development and manufacturing partner, we are thus a reliable and agile CDMO for our customers in the promising market segment of highly potent active ingredients.”

With the new building, Aenova will not only be able to better serve market needs and customer requests in the future, but above all reliably provide vital medicines for patients with cancer worldwide. In the next few months, the laboratories and the new “on-demand” GMP area will be set up. Customer orders can go into production from 2024.