The two dedicated suites in Visp, Switzerland will support commercialized antibody-drug candidates (ADCs) products for an undisclosed biopharma customer.

Contract development and manufacturing organization (CDMO) Lonza has announced 1500 m² of active manufacturing space will be dedicated to the biopharma customer, in addition to established quality control (QC) labs, logistics and other central services, to

Charles Christy, head of Commercial Solutions Ibex Dedicate, Lonza, told us the customer has asked for confidentiality and so details are scarce, but the firm has said the high throughput bioconjugation suites will be capable of handling highly-potent materials for cancer therapies and will initially manufacture two therapies.

Image: iStock/DG

Around 200 staff will be employed, with operations expected to start from the end of 2022.

Ibex Dedicate

Lonza launched its flexible manufacturing ‘Ibex’ platform from its site in Visp, Switzerland in 2017, expanding the offering the following year to include dedicated production suites for its pharma customers.

The offering essentially gives companies their own facilities while being able to plug into Lonza’s network. While Lonza bears the initial CAPEX, the cost to realize a facility is picked up by the customer or shared with the CDMO, Christy explained.

“Lonza has pre-invested in Ibex Solutions through the construction of the new Biopark – an investment of around 400 million CHF, with the first manufacturing complex providing over 200,000 ft² (18,000 m²) of active manufacturing space. The pre-investment also includes building, utilities, and supporting infrastructure to reduce build time and facilitate such types of projects significantly,” we were told.

“The costs for the fit-out of the customer-dedicated suites to their specifications is borne by them or shared depending on the business model. This is one of the advantages of The Ibex Dedicate offer from Lonza; customers are able to co-create their manufacturing solution to their precise needs in terms of technology, scale, ramp-up and also tailor the commercial terms to meet their needs. The pre-investment also provides assurance of meeting critical timelines and achieving a robust and high performing facility.”

He added Lonza’s pre-investment in the Ibex Biopark allows customers to “either profit from the speed of build-out, such as was the case with Moderna for their COVID-19 mRNA vaccine or to take advantage of the speed of build-out to delay their decision until they obtain pivotal clinical data or confirmation of demand, and still make the market.”

Bioconjugation

The undivulged customer follows in the steps of Kodiak Sciences, which signed up to the Ibex Dedicate offering in July for the antibody biopolymer conjugate (ABC) candidate KSI-301, being investigated in late-stage studies for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).

According to Christy, the Ibex Dedicate model “is particularly interesting to companies with bioconjugated products” due to its flexibility and assured supply.

“Lonza was one of the pioneers in bio-conjugation starting in 2006 and provides the majority of approved ADCs as well as a wide range of other protein conjugates.”

It is of public record that Lonza supports the production of several commercialized bioconjugated products, including Roche’s Polivy (polatuzumab vedotin) and  Kadcyla (ado-trastuzumab emtansine).