CDMOs in ADC investments

Two European CDMOs have separately announced investments in antibody-drug conjugates (ADCs). Carbogen Amcis will co-invest over CHF 25 million with a long-standing Japanese customer, while Sterling Pharma Solutions has agreed a manufacturing partnership with Kivu Bioscience.

Carbogen Amcis will install 850L reactors and 0.4 m3 agitated filter dryers plus supporting equipment at its sites in Aarau and Neuland, with completion in Q1 and Q3 2027 respectively. This will support the production of a linker for a commercial ADC. It builds on an existing joint funding agreement the company made in April 2021 to extend its main site at Bubendorf, also in Switzerland.

“By investing in both Aarau and Neuland, we’re ensuring that our infrastructure keeps pace with our customers’ ambitions,” said Carl Baker, VP of the Drug Substance business unit. “These upgrades will allow us to seamlessly manage increased volumes while maintaining the operational excellence and containment controls required for highly potent APIs and advanced therapies.”

Sterling, meanwhile, will make cGMP-quality clinical material for Phase I clinical trials of KIVU-107, Kivu’s lead oncology ADC candidate, at its dedicated bioconjugation facility in Deeside, UK (pictured). Details were not disclosed but Sterling announced last October that it would spend £10 million to double Deeside’s GMP manufacturing capacity.

This agreement includes process familiarisation, analytical development, process optimisation and scale-up activities in preparation for a cGMP manufacturing campaign. KIVU-107 is described as a potential first-in-class antibody-targeted conjugate that enables site-specific conjugation. “The resulting structure positions the linker-payload in a natural cavity in the antibody, providing excellent stability, reduced hydrophobicity and an increased therapeutic index relative to first-generation ADC therapies,” Sterling said.