Lonza building out capacity to prep for ADC boom

CDMO Lonza already supports three of the five commercially available antibody-drug conjugates (ADCs) and is adding two news suites in Switzerland in preparation of future demand.

Contract development and manufacturing organization (CDMO) Lonza will expand its bioconjugation facility in Visp, Switzerland in readiness for a new wave of antibody-drug conjugates (ADCs) coming through the clinic.

“Many bioconjugates are on expedited programs and the existing expertise at the facility, combined with proximity to clinical and commercial manufacturing of antibody, linkers and payload, will reduce risk and increase speed on the path to market for Lonza customers,” Lonza said in its half year results this week.

Lonza’s ADC facility in Visp, Switzerland

Karen Fallen, head of Mammalian and Microbial Development and Manufacturing, Lonza Pharma & Biotech, added some color: “We are building two additional floors onto the existing building, adding two suites to the existing five.”

She continued: “The new conjugation suites will have a multi-purpose layout as the existing suites, with sufficient freedom to add equipment to match specific process requirements on demand.”

Fallen could not comment on the size of the investment but told us the expansion will last the next two years with new capacity expected on line by Q3 2021, and will support customers for clinical phases, launch and commercial production.

Lonza and the ADC space

ADCs are composed of an antibody linked to a small molecule cytotoxic payload. While the US Food and Drug Administration (FDA) approved the first such therapy in 2001 in the form of Pfizer/Wyeth’s Mylotarg (gemtuzumab ozogamicin), only four more have since received the regulatory thumbs up.

The latest is Roche’s Polivy (polatuzumab vedotin), approved by the FDA in June.

Lonza supports the production of Polivy from Visp, along with Roche’s Kadcyla (ado-trastuzumab emtansine), approved in 2013.

According to Fallen, Lonza supports a third ADC that the firm cannot disclose, thus three of the five commercial therapies are made at the Visp site.

“The bioconjugate space is a great example of how can support customers with and end-to-end solution. Having all elements (mAb, linker, payload, drug product) under the same quality system or even at the same site reduces risk considerably and simplifies what can be a very complex supply chain.”

The other approved ADCs are: Seattle Genetics/Takeda’s Adcetris (brentuximab vedotin) and Pfizer’s Besponsa (inotuzumab ozogamicin).

Lonza is not the only CDMO to invest in ADCs. In recent months WuXi Biologics, Aji Bio, and ADC Bio have all expanded their services in the sector.