Three invest further into ADCs

Three CDMOs have separately announced expansions in their antibody-drug conjugate (ADC) manufacturing capabilities and capacity on opposite sides of the Atlantic. This has come on the back of growing interest in this modality in the treatment of cancer, which has been forecast to grow at 15%/year to 2028.

Merck KGaA is to spend €70 million to triple capacity at its Bioconjugation Centre of Excellence facility in St. Louis. It will add 3,200 m2 more space for process and analytical development, QC, R&D, manufacturing and logistic, plus a dedicated buffer preparation facility, and a cold storage and a GMP-controlled room temperature warehouse close to the existing facility.

This follows on from the opening of a €59 million, 6500 m2 facility in Verona, Wisconsin, dedicated to doubling production of the most highly potent APIs, in 2022, and other technology innovations in the field. Merck, which is known as EMD in the US, was the first CDMO to be approved for ADC manufacture in the US.

Meanwhile, Sterling Pharma Solutions has announced that it will invest £10 million to more than double GMP bioconjugation capacity for ADCs in a 215 m2 suite with reactors of up to 500L in volume at its site in Deeside, UK (pictured). There will also be a 130 m2 Grade C cleanroom for manufacturing using flexible and hard containment technologies to handle highly potent molecules with exposure limits down to 0.01 µg/m3.

Processing will take place within flexible, single-use bioreactors to increase efficiency and eliminate the potential for cross-contamination between campaigns, with integrated automated transfer and control systems to reduce the need for manual operations, the company added, while stability chamber capacity for the storage and monitoring of final products will be upgraded. This should be complete in early 2026.

Finally, Lonza is to add two multipurpose, 1,200L manufacturing suites plus related infrastructure to the bioconjugation facility in Visp, Switzerland, for launch and commercial supply. When this becomes operational from 2028, it will add 2,000 m2 and double Lonza’s bioconjugates capacity for ADCs and other products. This follows an earlier customer-specific expansion in bioconjugates at the site.