Sterling Pharma Solutions and Kivu Bioscience Enter Manufacturing Pact

Under the agreement, Sterling will manufacture cGMP clinical material for KIVU-107 at its dedicated bioconjugation facility in Deeside, UK. The collaboration includes process familiarisation, analytical development, process optimisation, and scale-up activities in preparation for a cGMP manufacturing campaign.

“We chose Sterling as our manufacturing partner based on their deep expertise in ADC development, proven track record of clinical supply, and commitment to quality,” said Mohit Trikha, President and Chief Operating Officer, Kivu Bioscience. “This partnership marks an important milestone as we advance KIVU-107 toward first-in-human studies and deliver on our mission to bring kinder, gentler and efficacious next-generation ADC therapies to patients.”

KIVU-107 is 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.

“Our team at Deeside has extensive experience supporting complex ADC programs from early development through clinical manufacturing,” said Chad Telgenhof, Chief Commercial Officer at Sterling Pharma Solutions. “We’re excited to support Kivu to bring this promising new oncology candidate into the clinic, leveraging our expertise and investment in world-class ADC development and clinical manufacturing capabilities.”

Sterling’s 6,500 m² Deeside facility offers a range of ADC services, from discovery-stage development through to clinical supply. In October 2024, Sterling announced a £10 million investment at the site to double its GMP manufacturing capacity, as the second phase of an ongoing strategy to increase the capabilities that it can offer customers.