An interview with the Managing Director of Aenova’s Regensburg site, Oliver Schmied.
The Aenova Group is a leading global contract manufacturer and development service provider for the pharmaceutical and healthcare industries. As a full-service provider, Aenova develops, produces and packages all common dosage forms, product groups and active ingredient classes of pharmaceuticals and food supplements for human and animal health: solid, semi-solid and liquid, sterile and non-sterile, high and low dose, OEB 1-5, and Fill&Finish of biologics/vaccines up to BSL-2. Around 4,200 employees at 16 locations worldwide contribute to Aenova’s success. Producing billions of capsules each year, Aenova is a partner of choice for novel product solutions as well as commercial high-volume manufacturing of hard capsule products. The company prioritises state-of-the-art technologies and boasts a network of 14 manufacturing sites that have EU GMP approval, 12 with FDA approval and 9 with ANVISA approval. At the Regensburg site, one of the leading HPAPI development, production and packaging facilities for high potent solids, production flexibility is a key issue, enabling small to large batches from 0.5 to 500 kg. Supporting the company’s strategy to expand production capacity within the coming years, IMA Active has consolidated its role as a frontline supplier of high-tech equipment by actively working with Aenova’s production engineers to fine tune the latest capsule filler and reach the customer’s key objectives.
Having acquired new business involving large volumes of capsules to be produced at the Regensburg site, we were faced with the need to significantly increase our filling capacity as early as possible. Our focus was on obtaining highly efficient processes with a view to achieving maximum flexibility to best meet all customer requirements. It was evident from the start that we needed to implement the most recent, innovative technologies to reach our goals.
We had to address a number of issues, some of which were critical, so the most valued aspect of
our relations with IMA can be summed up in a few words: transparent, open discussions and constructive input to find all the right answers. This is the basis of a true professional partnership and the benefits go in both directions, to the customer and the supplier. To mention one issue, considerable efforts were made by IMA’s engineering team to successfully install the new Adapta capsule filler into extremely limited floor space. Further to this, we were assured that the Adapta 200 could handle our products and during the preparatory stages of the FAT (Factory Acceptance Test; FAT is one of the qualification phases in the course of GMP qualification), together we were able to test the products of the machine and implement the ideal settings to guarantee optimum results.
That’s right. 1990 marked the first purchase of a Zanasi capsule filler, the Zanasi 40 for commercial purposes. We then bought an additional Zanasi 5 and in 2021 acquired a Zanasi 12 which was devoted to batch development activities at our pilot plant, which was established as an in-house development facility between 2009 and 2010.
Most of the products have been developed using the Zanasi equipment and subsequently tested and successfully manufactured on Adapta using the same filling principle. This eloquently reflects our many years of in-depth know-how in the field of development through to commercial production at the Regensburg site, especially for highly potent active ingredients such as those used against cancer.
Firstly, let me say that in keeping with the Aenova Group’s policy to adopt cutting-edge technologies, the choice landed easily with Adapta 200. We immediately recognized the value of a high-speed solution enabling full scalability and large production capacity. The compact footprint has allowed us to free up enough space to include further potential filling requirements, which fits perfectly with our objective for increased capsule filling capacity.
More specifically, we are extremely satisfied with the real speeds reached. An output of 200,000 capsules/hour is exactly what we needed and Adapta 200 consistently achieves these figures. Let me say that many times the declared speed is not the real speed, but in this case there is no difference.
Another aspect which has impressed us is the 100% in-process weight checking capability. Real time monitoring and measuring of capsule weight is handled by the system directly connected to the machine, giving us the peace of mind that key parameters are respected.
Last but not least, despite the space-efficient size of Adapta, and even with different dose combinations, the high production speeds are maintained. Finally, it is equally important for us to underline the broader benefits we enjoy from a product landscape that IMA has installed at our Regensburg site. The Zanasi machines – in particular the 12 E and the AZ 5 – are perfectly sized either for small batches or for product development activities. Together with the larger Zanasi capsule filler and the latest-generation Adapta 200, we are well-placed today to deliver the most flexible response to all our customers. And in today’s market, that is vital.
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