Kivu Bioscience Partners with Sterling Pharma for ADC Clinical Manufacturing

• Kivu Bioscience has partnered with Sterling Pharma Solutions to manufacture cGMP clinical material for its ADC candidate KIVU-107.

• The work will take place at Sterling’s dedicated bioconjugation facility in Deeside, UK, supporting Phase 1 trials.

Kivu Bioscience, a biotech firm focused on next-generation antibody-drug conjugates (ADCs), has announced a manufacturing agreement with Sterling Pharma Solutions to support the clinical development of its lead oncology candidate, KIVU-107.

The contract will see Sterling, a global CDMO, manufacture cGMP-compliant material for KIVU-107 at its bioconjugation facility in Deeside, UK. The partnership covers process familiarisation, analytical development, optimisation, and scale-up activities in preparation for clinical supply.

KIVU-107 is described as a potential first-in-class ADC that uses site-specific conjugation to achieve improved stability and therapeutic index compared to first-generation ADCs.

“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, Ph.D., President and COO of Kivu Bioscience.

“Our team at Deeside has a strong track record in supporting complex ADC programmes from initial development through to clinical manufacturing,” said Chad Telgenhof, Chief Commercial Officer at Sterling Pharma Solutions. “We look forward to working with Kivu to advance this promising oncology candidate into clinical trials, drawing on our expertise and investment in high-quality ADC development and clinical manufacturing.”

Sterling’s Deeside facility spans 6,500 square metres and supports ADC development from early-stage work through to clinical manufacturing. In October 2024, the company announced a £10 million investment to double its GMP capacity at the site.