Aenova Expands Production of Tablets with Highly Potent Oncology Drugs
Contract manufacturer Aenova has put a third, high-performance tablet press including integrated automatic in-process control into operation at its site in Regensburg, Germany, to expand its production capacity of highly potent oncology drugs.
The company said that the expansion was made in order to meet the increasing demand of customers for preparations in the oncological environment with highly potent active ingredients (HPAPIs), such as cytostatics, immunosuppressants or hormone-containing products.
With an investment of around €500,000 and now a total of three identical, automated tablet press lines, Aenova will be able to produce up to 1 million tablets per hour in the field of highly potent oncology drugs.
The tablet presses are connected online with three combination upward dedusters and the automatic in-process control equipment. This enables the weight, dimensions and breaking strength of tablets drawn at defined times to be checked regularly and fully automatically.
The use of automatic online in-process control equipment now enables an uninterrupted, regulation-compliant and quality-assured manufacturing process for the tablets, independent of occupational safety regulations, said Aenova. In the area of highly potent products up to the OEB-5 class, special protection must be guaranteed due to the hazard potential for the production personnel.
Christine Beck, SVP of the Solids Business Unit at the Aenova, said: "The implemented expansions are related to the strategic positioning of the Regensburg site as Center of Excellence HPAPI and Oncology Products within the Aenova Group. For this purpose, an extension building for the so-called HPAPIs (High Potency Active Pharmaceutical Ingredients) is planned to be built until 2022 as well as an expansion of the production capacities for hard capsules for high-potency products.”
In Regensburg, Aenova produces and packages an extensive range of solid, semi-solid and liquid dosage forms.
