Five minutes with Dr Sylke Hassel, SVP and Business Unit Head, Mammalian Manufacturing, Lonza Pharma & Biotech – DCAT Week ‘18
PH: Can you introduce the business unit and its products?
Hassel: Mammalian Manufacturing is one of the major parts of Lonza Pharma & Biotech. It covers products starting in Phase II and III to commercialisation, following on from our Clinical Development business unit. Our strategy is to offer end-to-end solutions over the lifecycle of the product. Customers have access to small-, medium- and large-scale manufacture at 2,000, 5,000-6,000 and 20,000 litres respectively. Our global network of sites gives customers different scale options across the US, Europe and Asia.
PH: How is business in the US?
Hassel: With the current political situation in the US, we are seeing more attraction in US-based manufacturing. It was a trend before but has accelerated now, as companies are repatriating money and feel supported to manufacture in the US. We recently acquired a site in Hayward, California, from Shire for clinical development and manufacturing. Our Portsmouth, New Hampshire, site deals with mid- and large-scale. We also offer companies a number of different business models to enable them to better manage strategic investments and offset risk.
PH: Can you give some examples of that?
Hassel: At Portsmouth, we recently opened a mono-suite with Alexion. This gives them dedicated capacity and flexibility, while being able to tap into central facilities and expertise. In Europe, we are expanding our site at Visp in Switzerland, which already has established small molecule and microbial manufacturing, with a new offering called Ibex solutions. This campus of five biomanufacturing complexes is built around central facilities and connects into our established know-how and service network at Visp. One is a joint venture with Sanofi for large-scale biologics production, an initial investment of around €270 million split equally between each company. The capacity will be shared 50-50 and we have the option to expand further when needed. The goal is to offer a flexible facility where we can support customers by de-risking their manufacturing strategy.
PH: How do you do that, exactly?
Hassel: Each Ibex complex will have two wings with nine technology-agnostic modules each. Customers can take one module in the clinical stage, and then if they hit a milestone or see additional demand, they can expand from 2,000 right up to 20,000 litres. The entire central infrastructure including media and buffer plants is in place and together with pre-built shells, this reduces the time to market and ensures flexible capacity is there when needed. Lonza is probably the only CDMO who can share risk with our customers at this scale, reducing their capex exposure whilst maximising agility.
PH: Have you made any other recent investments in mammalian manufacturing?
Hassel: Another has been in Singapore, our Asian hub, where we have invested in a 2,000 litre single-use reactor facility that we are starting up now. The skill set we have there made it the ideal place to set up a fully dedicated, small-scale facility in single-use that covers late-phase clinical to commercial production. The facility serves the global market, as some of our customers dual-source and Singapore is interesting from a tax strategy point of view. Hayward was another and we are now working on remodelling and upgrading it, bringing it in line with Lonza processes and technology, ensuring smooth tech transfers to and from our other sites.