Jan Kengelbach, CEO,

AENOVA GROUP

"While it's always easier to deny a certain service if you don't yet have the technical expertise in a particular area, in the long-term it is advantageous to explore the possibility of investing in that area with the customer."

Can you introduce our readers to core operations of Aenova Group (Aenova)?

Aenova is one of the largest CDMOs worldwide, with US$700 million sales, spanning the entire dosage form spectrum and nearly all therapeutic areas. We are organized in three business units: solids, semi-solids, and liquids, offering end-to-end services from new chemical entity discovery through clinical phase management to market release. We have 500 customers and operate out of 14 sites in Europe and one in the US.

What are the main strategic positionings of CDMOs in today’s life sciences industry?

Within the CDMO space, there are a few options for how to strategically position yourself. Historically, the majority come from a more CMO-oriented place, in which you are basically an extended capacity provider for products older in the lifecycle. To do well going this route, you must understand optimizing efficiencies and economies of scale. The competition on older lifecycle products is more pronounced. If you want to participate in the strategic and cutting-edge manufacturing of drug products, however, you need strong development and tech transfer services.

Additionally, it depends on the type of customers and products you want to attract. Bigger pharmaceutical companies have their own development teams but may still need a manufacturing and development partner to bring their product to market. Leaner players often pursue an asset-light model with virtually no manufacturing footprint and are dependent on a fully integrated development service provided by their CDMO partner. As such, which strategic approach you take to the market and where you want to play determines the services you must provide.

How important is innovative technology for CDMOs to stand out from their competition?

It is imperative to have a technological edge. Aenova was already the top CDMO for solid dosage forms in Europe, but we thought critically about what unique technologies we could provide at our 12 sites with solid dosage form capabilities to distinguish from the competition. If a customer might have a more complicated request, like a multi-unit pellet system, we can provide the appropriate level of scientific expertise and cutting-edge process technology such that the client immediately trusts they have found a reliable counterpart. Recently, we won a project on highly innovative intra-oral implants, something that is not obvious to do in solid dose manufacturing. We got this contract because of our upfront investments in the right scientific and technological expertise.

Can you elaborate on the technologies Aenova currently offers its clients and how it decides what new technologies to invest in?

Recently, Aenova has focused on bringing in new, differentiating technologies. None of these are new to humankind, but for many it is the first time they are offered on a CDMO platform of our size. Many are related to enhanced bioavailability of the drugs. We have several projects in our high potency area, particularly in oncology, where we take injectable drugs and try to convert them into solids by applying innovative technology and drug formulation concepts. We also offer sophisticated over-encapsulations, in which we can put an immediate and sustained release tablet in a capsule to design the therapeutic effect of different molecules. Aenova has also built a dry powder inhaler platform and can make micro-dosed filling comprised of tiny quantities of the API down to the microgram. As the second largest softgel capsule player worldwide, we see increased demand for microcapsules, softgel capsules the size of the head of a needle. These are only few examples of innovative technologies Aenova can offer its clients.

With these technologies, the company has gained access to a new set of customers willing to co-invest in these projects with us. The problem with many large-scale providers is they do primarily older lifecycle products, but we are clearly committed to bringing newer lifecycle products to life. We remain open to requests that require an update to our current capabilities. While it's always easier to deny a certain service if you don't yet have the technical expertise in a particular area, in the long-term it is advantageous to explore the possibility of investing in that area with the customer. This is the partnership approach and the change in mentality we successfully implement. The minute you have your first proof of concept, more requests will come quickly and you are off to building a new growth platform.