Five minutes at CPhI worldwide with …

Angelo Gatto Senior Vice President Global Sales and Marketing – AENOVA

Chemistry Today /Pharma Horizon: The CMO/CDMO industry is apparently trending towards “one-stop shop” solutions. Is this the aim Aenova is striving for?

Angelo Gatto: As a matter of fact – with 16 manufacturing sites in six countries – Aenova provides with manufacturing and development services for almost all the dosage forms. This includes tablets, hard capsules, soft gel capsules, gels, creams, ointments, as well as injectables (either liquids or powders). It comprehends management of containment of APIs such as hormones, antibiotics and cytotoxics. However, it is not our strategy to become a 100% one-stop shop. Our goal is to be the preferred CDMO for our Customers in our core business areas, this means to focus on the technologies we excel and perform best.

CT/PH: Which technologies are likely to be focussed on?

AG: Aenova offers a diverse, comprehensive range of technologies throughout segments which cover pharmaceuticals, consumer healthcare and animal health. In each of these segments Aenova plays an important role as Europe’s No. 1 CDMO, and number three worldwide. For instance, production of solid dosage forms is one of Aenova’s core competences and therefore our biggest technology platform by volumes. Indeed, we also are the No. 1 independent soft gel capsules manufacturer in Europe. Here we leverage our decades of experience in the production of high quality soft gel capsules made in Switzerland and Romania. Moreover, we have a good position in the injectables sector, with three manufacturing sites -two in Germany and one in Italy. And with that platform we cover high potency compounds, such as cytotoxic or cytostatic; -as well as beta-lactams, such as penicillin or cephalosporin in dedicated areas at the mentioned facilities. Two further sites in Germany and Italy are highly specialised on semi solids, which can also offer development capabilities.

On the other hand, we should not limit the focus to technologies. As contract manufacturers and developers, we are service providers, and our business objective is to build long lasting trusted relationships with our global Customer base by excelling in all the three strategic imperatives: Product QualitySupply reliability and service delivery and Cost competitiveness.

CT/PH: Indeed, you plan to expand your operations in Romania.

We continue to expand our strategic and leading market position in the field of soft gel capsules. Our site in Romania offers perfect conditions for this. With our investment of around 14 million euros, we will increase production capacity at this site by around 40 percent up to more than 14 billion capsules a year. The expansion is expected to be finalized in spring 2019. Additional modern production and warehouse facilities will be established and the site will be equipped with state-of-the-art production technology. Our expansion projects are not limited to soft gel capsules. We have just implemented a new manufacturing area in Latina in Italy, dedicated to veterinary solids for USA market, and more expansion projects are on-going and further under evaluation.

CT/PH: What trends does Aenova see in dosage forms?

AG: Obviously, there are specific trends within each segment. The business of biosimilars and biologics is still under development, on which also Aenova is exploring, and in this direction we see a future of specialty drugs that will target specific patient segments. Under a more visionary perspective, the future will bring personalised medicines that target the need of the individual patient. However, in the short term, solid tables will continue to be the most common dosage form in pharmaceuticals, in all segments.

CT/PH: What other innovative projects are you working on?

AG: As I said, we are service providers and we shall continuously focus on improvement and innovation to assure efficiency and effectiveness. Aenova focuses on both product and process innovation. We have innovation projects, run at Corporate level, that will generate transformation improvement in our processes. The most advanced is related to centralisation of Quality activities, such as incoming good testing under the concept of Lean-Lab . However, we are also active in product innovation, through the newly established business Unit of Development Services, where we have selected co-development projects partnering with some of our Customers.  If we then look at the Animal Health industry, where we are the leader CDMO, we have quite a deep business relationship with almost all the top 10 veterinary players worldwide. We do not work on discovery, but we are involved in the product development. Without releasing confidential details, I can say that we are working on the improvement of the efficacy of product administration. This applies to administering devices (e.g. for food animals) or, in case of companion animals, measures that improve compliance by making the products more palatable and easy to administer. This will help pet owners to comply with the therapeutic prescription.

CT/PH: Do you employ continuous manufacturing?

AG: Due to the importance of solid manufacturing for us, we have explored continuous manufacturing both in granulation and in coating. It is a very good opportunity if we link this to the product analytical technology (PAT) introduced by the FDA years ago. With the PAT the FDA opened the door to parametric release of the production, and in combination with continuous manufacturing it would be ideal for products with high volumes. However, we judge this is not yet completely mature. Neither for manufacturing, since the technology has not been fully finalized, nor on the regulatory side. We should consider that the real advantages come from the production of very high volumes (typically blockbusters, or generics that originate from blockbusters). It requires a big effort, perhaps not justified by the benefits, to submit a variation that transforms a dossier from a traditional batch manufacturing into a continuous manufacturing process. Nevertheless, it makes sense for new registrations and the role of CDMO can be relevant if there is an involvement since the early phase of product development. Of course, the application is less challenging in the field of consumer products, particularly in the nutritional segment.  

CT/PH: What is your take on CPhI 2017?

AG: To be very honest I can only speak about Aenova. The Aenova-team and myself have been so busy with scheduled meetings, plus unplanned, that I didn’t have time to visit any other booth and benchmark the trend of CPhI overall. For us it has been very successful; due to a very open exchange we received tangible confirmation of trust by our established Customers, more than 500, but also that there are still emerging players we are discussing with. There is a substantial room for growth and we believe that the CDMO industry in Europe will keep on playing a major role in the coming years.