for 30 % of the total and this will grow in the next ten years. ADC growth is continuing rapidly,“ which is not only a challenge of molecule complexity but also of supply chain complexity”.
To address these challenges, Lonza is basing its strategy on four‘ pillars’. It plans to sell its Capsules business and become a pure-play CDMO for healthcare. It is reshaping itself, as subsequently announced in April, creating three main platforms to become more agile. Thirdly, it will continue to invest in more advanced technologies and find ways to build both faster and cheaper.
Finally Lonza will continue to expand, on top of the CHF 1.4 billion it has already invested in recent years. Most of this was the acquisition one year ago of Roche-Genentech’ s facility at Vacaville, California, which doubled its capacity. The company is now fully operational there, having spent CHF 500 million in technology and equipment. The first tech transfer contract has just been signed.
Lonza has also just added two bioconjugation suites for ADCs at its main site in Visp, Switzerland, doubling the scale from 600 to 1,200 L. Lonza is seeing work in this field in part because Western firms are licensing ADCs in after they have been developed to proof of concept in China.
The challenge, Dr Jan Vertommen, head of commercial development for advanced synthesis, told SCM, is two-fold: there is limited time to build capacity and the processes developed for early-phase production may not be good enough for commercial-scale manufacture.
They then, like biotechs, need CDMOs to sort out the chemistry, manufacturing and control( CMC) work.“ I thought maybe 20 years ago it was getting like that but now it’ s getting even worse. There is this mindset that someone else will solve it, either internally or at a CDMO. CMC is often treated very lightly,” he observed.
At nearby Stein, Lonza has added large-scale capacity for vials and prefilled syringes, with a view to offering more integrate services in drug substance( DS) and drug product( DP). The company is also building custom suites for long-term lease to customers through coinvestment, notably in ADCs and cell and gene therapy( C & GT).
Vertommen added that the company saw“ very nice growth” of above 9 % last year in small molecules, compared to 5-6 % for the market. Oncology remains the key driver here accounting for about 40 % of Lonza’ s programmes, with obesity drugs also strong.
Carbogen-Amcis ' s Saint-Beauzire facility is part of a strategy of focusing on high potency
Seqens has invested in high potency at the Aramon site near Avignon
Big-scale biologics
Lars Petersen, CEO and president of Fujifilm Diosynth, also cited supply chain complexity as the key challenge, notably in monoclonal antibodies( mAbs) and ADCs. The company is responding by building“ an ecosystem where we are basically designing, constructing and operating all our sites in the same manner”.
Integrated plants at Hillerød, Denmark, and Holly Springs, North Carolina, will open in six to nine months’ time. Each has eight bioreactors and operates at 20,000 L scale, being able to handle 15 g / L. They are about 97 % correlated in their operations, Petersen said, so that customers can get approvals from both at the same time. A further eight will follow at Holly Springs in 2028. Since DCAT Week, the firm has signed a ten-year deal to supply manufacturing services to Regeneron out of Holly Springs.
20 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981