- Swiss contract manufacturer Lonza is adding to its Visp, Switzerland site two new manufacturing suites focused on constructing antibody-drug conjugate payloads, showing confidence in the prospects of the large molecule technology.
- Lonza noted the investment in ADC capacity will be, in part, to support an agreement with an undisclosed "major biopharmaceutical partner."
- The first suite will be earmarked for the global partner, while the second will be available to other customers for similar high-potency active pharmaceutical ingredients and payload development programs. The expanded production capacity should be online by the end of next year.
Antibody-drug conjugates link monoclonal antibodies with potent small molecule drugs, aiming to selectively deliver cytotoxic payloads to tumors, for instance.
While the promise of these molecules has been high, few have made it through to market — with Seattle Genetics' Adcetris (brentuximab vedotin) and Roche' Kadcyla (trastuzumab emtansine) the most notable. More recently, Pfizer won U.S. approval for its Besponsa (inotuzumab ozogamicin).
Vivek Sharma, CEO of Piramal Pharma Solutions, wrote in a report published this month by CPhI that third-generation ADCs have offered "reasons for optimism" in the field, compared to more limited earlier versions. Clinical testing has also increased, Sharma noted.
"Nearly 202 ADCs have been entering into clinical trials out of which 116 are actively progressing. There are about 23 new ADCs in last 12 months increasing at a rate of 30%," wrote Sharma.
Companies developing antibody-drug conjugates face technical and manufacturing challenges. Many companies, therefore, choose to partner with CMOs or CDMOs such as Lonza.
"Most of the pharmaceutical companies have opted to outsource the manufacturing of their ADCs, with approximately 70% of all ADC manufacturing activities conducted by CMOs," Sharma wrote.
Lonza declined to name its pharma partner due to confidentiality. However, Maurits Janssen, head of commercial development for API at Lonza Pharma & Biotech, said in an email to BioPharma Dive that the deal would permit more flexible supply to keep in sync with customer requirements.
ADCs developed and manufactured at Lonza include 11 investigational new drugs, nine new product introductions in its commercial plant, two drugs at biological license application stage, and two commercial ADC therapeutics.