PH: Lonza has been through some restructuring after all its recent changes. Where does the unit you head sit within it?

Christian Dowdeswell

Dowdeswell: Dosage Forms & Delivery Systems is one of two units within the Chemical division of Lonza Pharma & Biotech, alongside API Development & Manufacturing. It is basically the oral drug product services offering, combining Capsugel Dosage Form Services with the Micromacinazione site in Switzerland. Micronisation is one of the last steps in the process of making the API or the first thing in formulation. Our customers define it in various different ways, but we decided to make it part of the drug product offering because we quite often use it as a tool to boost solubility and enhance bioavailability.

PH: What has Capsugel brought that Lonza did not have before?

Dowdeswell: Lonza was essentially in small molecules as an API provider, mainly of NCEs for innovators. By buying Capsugel we gained access to a network of sites around drug product services, where we have tools that help us address some of our customers’ key challenges – mainly when it comes to enhancing bioavailability. The small molecules market has a number of prevalent trends that have been growing for some time. First, smaller companies are driving early phase innovation, which saw a surge last year; second, the increasing complexity of the products that also tend to be poorly soluble – 70% of products in development have a BCS 2 or 4 classification; third, they are increasingly potent, both in API and drug product; and fourth, there is an accelerated time to market. More and more, drugs are also subject to accelerated approval, which is something Lonza already excelled at. Capsugel brought enabling technologies including micronisation, spray-dried dispersion to create amorphous materials and solutions like lipid multi-particulates, soft gels or liquid-fill hard capsules – all ways to address bioavailability challenges. These tie in well with our other capabilities in high potency APIs and with the needs of emerging companies, who have limited resources and specific technology needs. We now have the tools to address them.

PH: Do these small companies prefer to come to a Lonza or other large CDMO that has all these capabilities?

Dowdeswell: Increasingly so, yes. In the last few years, we have looked very hard at our business model and asked what the small players in this new market would want from us in the development phase and into commercialisation. Our aspiration is to give our customers everything, from early intermediates through to the API, drug product and more – but we also make it very simple for our customers to dip in and find the services they need to solve their problems. Our expertise allows them to focus on what’s really important to them – getting their drug to market.

PH: Is business good?

Dowdeswell: Lonza had a record year last year. Clearly, this was partly through acquisition but we also had strong organic growth in our mammalian, clinical development and chemical manufacturing businesses. I think people are increasingly looking for value from their service providers and we are one of the premier suppliers in that space.

PH: Are small suppliers your main target market now?

Dowdeswell: Increasingly, we find small companies trying to commercialise drugs themselves rather than sell them on after the early phases. There are some public domain examples. For instance, we are putting up a site for Clovis’s Rubraca at Visp and they still own the compound. We are looking very actively at how we best support these companies through a partnership approach.