Aurinia Pharmaceuticals Inc., a clinical stage biopharmaceutical company specializing in global immunology, recently partnered with Lonza for the manufacture of voclosporin active pharmaceutical ingredient (API).
“Throughout the company’s long relationship with Lonza, we have developed substantial proprietary know-how in manufacturing commercial scale voclosporin,” Lawrence Mandt, vice president of Regulatory and Quality at Aurinia, said in a statement. “We believe this know-how has the potential to broaden our exclusivity position for voclosporin and ensure high quality, reliable production of the API.”
Lonza will provide Aurinia with cGMP-grade voclosporin drug substance for use in Aurinia’s Phase III lupus nephritis clinical program. The agreement, which also provides an option to have Lonza exclusively supply API for up to 20 years, comes on the heels of a successful multi-year clinical manufacturing relationship.
“We’re looking forward to further developing our partnership with Aurinia to supply this innovative medicine to lupus nephritis patients around the world,” Lonza Senior Vice President Gordon Bates said. “As Voclosporin requires a complex manufacturing process, our expertise in scaling multi-step synthesis at clinical and commercial scale allows us to support Aurinia to and through Phase III clinical trials.”