Can you detail the synergies unlocked since the acquisition by Olon S.p.A in 2017?

Olon Ricerca Biosciences, from Italy, operates a broad range of specialty chemical manufacturing with total revenues of around US$580 million p/a. This was a strategic buy, as our site in Concord, OH, is focused more on early-stage development up to phase 2 to keep clients up to phase 3 towards commercial manufacturing. We started unlocking synergies in 2022, as our site was able to operate on its own, and we began working more closely with Olon’s regulatory affairs group. Most of our clients are in the smaller and mid-size end of pharma companies. We have over 300 active DMFs in the organization. Olon’s overall business is approximately 60% generic and 40% CDMO work. We are working to shift this closer to a 50/50 stance.

We see ourselves more as a service provider than a manufacturer, we want to supply services for custom APIs, toxicology, and in clinical programs.

What is your relationship with the FDA?

Our last FDA inspection was in 2019 and resulted in no findings, so we became a low risk for them. The biggest challenge is that the FDA is understaffed and cannot do inspections as regularly as they could in the past, and this will take several years to address. 

Do you see a wider onshoring trend in 2023?

Absolutely. Having the group in China and finding operational vendors has been key during the pandemic.

Today, a lot of firms that run their programs in Europe, for instance, come to us to have the API locally to get to the drug product manufacturers in the US. When you lock in a drug product manufacturing slot, you cannot afford for your API to show up late. Being able to assure we can get things done promptly is strategically critical for clients.

What is your approach to investment in new technologies?  

Olon S.p.A has some of the world’s largest capacities for highly potent APIs, and for manufacturing of cancer drugs that require full containment. What we are doing here is beginning the build-out of a high-potency API suite, so that we can get up to a few hundred grams made for early studies and transfer those processes to our sites in Italy for the clinical trial phase. We have heavily invested in our analytical capabilities; we have a lab that can support early med-chem up to phase 2 and commercial manufacturing. We recently purchased a high-resolution mass spectrometer, and such tools are key to evaluating clients’ molecules.

With energy shortages having repercussions on drug shortages in Europe, how did Olon adapt?

In the US, the impact is certainly lower than in Europe. We decided to shift some smaller manufacturing projects to the US. It makes more sense capacity-wise (we have smaller reactors) and we will not have high-cost impacts. Worldwide, a struggle has been sharing energy cost rises with some clients. In the generics drugs business, you typically sell products at a certain cost per kilogram, and this is where energy shortages can become an issue resulting in possible drug shortages.

Can you expand on Olon’s education and corporate sustainability initiatives?

The research program we launched will primarily be focused on Italy, but we recently found out that we could apply for a blanket visa to move people easier to the US. We currently have one intern within Olon USA, the group that does generic sales in the US. We are looking at bringing people from Italy, Spain, or India to our site. The program is very interesting; it takes a recent graduates and brings them exposure to the different services Olon offers. From a sustainability standpoint, the goal is to reduce energy consumption by 60%, use regenerated water, and increase recycled waste by 50% by 2025. In 2022, Olon invested at five of the 11 sites in solar panels to increase its focus on renewable energies. 

What is the goal for 2023?

Olon works with lots of big pharma customers, whereas ORB is on the development side and focuses more on smaller players. One goal is working as a team to take on the earlier stage projects and allow the bigger group to take more projects into commercialization.