Contract development and manufacturing organization Lonza has completed the expansion of its highly potent API (HPAPI) multipurpose suite in Visp, Switzerland. The expansion gives Lonza additional development and manufacturing capacity for antibody-drug conjugates (ADC) payloads. The site includes a range of equipment for manufacturing payload linkers.

Divided into cleavable and non-cleavable types, linkers are a vital component of ADCs as they connect an antibody with a drug (payload) through a chemical bond.

Lonza anticipates that the ADC market will grow swiftly, given the demand for novel targeted cancer therapeutics.

The company has announced a series of expansions in recent years, including investing in upgraded drug manufacturing services last year.

To learn more about the most recent expansion, we reached out to Lonza’s Giovanna Libralon, senior director, commercial development, small molecules and Iwan Bertholjotti, senior director, commercial development and strategic marketing of bioconjugates.

Could you provide a brief historical background of Lonza’s ADC integrated services?

Bertholjotti: Lonza offers integrated development and manufacturing services across antibody-drug conjugate (ADC) components: antibodies, payloads, bioconjugation and sterile fill/finish. Our strategic sites in Visp, Switzerland and Nansha, China, allow us to produce all these components under one roof. This development model enables time- and cost-efficiency to produce our partners’ ADCs. It also allows us to meet accelerated development timelines that many new compounds currently experience, which is extremely important to a commercialization strategy.

Libralon: We began our small molecule activities in Visp, Switzerland, about 50 years ago and introduced highly potent capabilities in the nineties. We continued to grow our synergetic capabilities in that site for highly potent APIs and bioconjugates such as ADCs, among other pharmaceutical applications. Our recent expansion at our Visp facility strengthens these integrated services. It enlarges our capacity for ADC payloads, supporting the entire development and manufacturing pipeline from feasibility studies to clinical and commercial supply. This latest investment signals continued momentum for Lonza in ADCs development and manufacturing.

Why was Visp selected as the site for the HPAPI offering and expansion?

Libralon: Visp is our Center of Excellence for highly potent API development and manufacturing. There is a dedicated team of experts who have produced more than 300 cGMP batches and developed 15 payload linkers and 50 HPAPI programs in the past decade. Moreover, Lonza Visp is the largest and oldest site in our global network of more than 30 sites and one of the most significant for research and development and manufacturing.

Bertholjotti: Our Visp facility also includes our biologics portfolio, where we develop and manufacture monoclonal antibodies, complex proteins and recombinant proteins. Strengthening our integrated ADC services at our Visp site allows us to continue serving our global partners.

Can you share more about how the expanded multipurpose suite will assist with payload linkers development and manufacturing?

Libralon: The new HPAPI suite enables handling compounds with an occupational exposure limit down to 1 ng/m³, with various containment solutions and a flexible setup for executing different types of operations. Equipment on-site includes reactor sizes from 1 L to 50 L with a temperature range of –80°C to +150°C, isolation and drying equipment, lyophilization and chromatography for the manufacture of payload linkers.

This investment allows us to increase capacity and add larger equipment for commercial manufacturing, supporting our partners’ ADCs to meet the growing global demand for these therapies.

Can you provide more context on the ADC market?

Libralon: The demand for ADC payloads is driven by the need for improved anticancer therapeutics with fewer side effects. Although every component of the ADC is essential to its therapeutic activity, the payload is the one that kills cancer cells. These payloads are almost always small molecule highly potent APIs. Carefully selecting the right one is incredibly critical as it needs to have the desired clinical outcome yet not so toxic that the side effect is unmanageable.

Bertholjotti: Many cancer therapies on the market cause damage to healthy tissue outside of the therapeutic area. This off-target activity results in adverse side effects for the patient, making their life even more difficult atop of fighting this already-challenging condition. The precise nature of the ADC decreases these side effects, which is exactly what drives the demand for anticancer ADCs.

Could you provide any details on sustainable features of the Visp HPAPI site?

Bertholjotti: At our Visp site, we actively support our global initiative of Vision Zero, the aspiration to work without incidents and reduce emissions, water consumption and waste. In addition, with the help of our Green Team of employee volunteers, we are supporting a number of social impact and environmental projects in the areas of mobility, recycling and environmental education in our local community.

Some of our ongoing projects include ensuring new buildings are equipped with solar panels, where possible, to support renewable energy generation on-site. In 2021, we sourced 28% of the electricity we purchased from renewable sources.

Libralon: We operate our waste and wastewater treatment facilities. In 2021, the projects implemented in the small molecules processes in Visp (CH) avoided 4,400 tons of wastewater, saving more than 900 tons of fuel-related CO₂ -eq. We also continue our solvent recycling efforts. In 2021 the site regenerated 6,600 tons of solvent and treated 4,300 tons of contaminated water to reduce incineration.