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Aims to establish global commercial manufacturing capacity for Vaxcyte's PCV candidates, VAX-24, and VAX-31.
October 16, 2023
By: Anthony Vecchione
Vaxcyte, a clinical-stage vaccine innovation company, and Lonza, a global manufacturing partner to the pharmaceutical, biotech and nutraceutical markets, entered into a new commercial manufacturing agreement to support the potential global commercialization of Vaxcyte’s PCV candidates, VAX-24 and VAX-31. This agreement complements Vaxcyte’s plans to utilize existing Lonza infrastructure to advance clinical development and the anticipated initial U.S. launch of VAX-24. Lonza will provide Vaxcyte with a custom-built manufacturing suite as part of Lonza’s Ibex Dedicate Biopark at its Visp (CH) site to manufacture key components, including drug substances, for Vaxcyte’s PCV franchise. Beginning with VAX-24, which is moving into late-stage clinical development, Vaxcyte’s dedicated manufacturing suite is expected to meet the potential long-term market demand. The design of the dedicated manufacturing suite is nearly complete, with equipment installation expected to begin in 2024. Lonza is anticipated to create up to 300 new jobs upon reaching peak capacity. VAX-24 was designed to address the serotypes that are responsible for a significant portion of invasive pneumococcal disease (IPD) in both infants and adults. “Following the successful completion of our VAX-24 Phase 2 adult studies, and as we prepare for Phase 3 clinical studies, we are excited to expand our relationship with Lonza, a preeminent contract development and manufacturing organization, and put into motion the key steps required to establish large-scale and long-term commercial manufacturing capacity for our PCV candidates,” said Grant Pickering, CEO and Co-founder of Vaxcyte. “This outcome is consistent with our strategic objectives and financial plan. We expect this dedicated manufacturing suite within Lonza’s Ibex facility will enable us to scale up effectively to meet the potential supply demands for VAX-24, followed by VAX-31, our 31-valent PCV, across all populations and on a global scale.” “Our expanded relationship with Vaxcyte highlights the value of our services on the path towards commercialization,” said Jean-Christophe Hyvert, president, biologics division at Lonza. “Having supported the early-stage clinical development of Vaxcyte’s PCV programs, we are pleased to continue our long-standing collaboration by supporting the late-stage clinical manufacturing utilizing our unique Ibex Dedicate offering, with the capability to provide commercial supply of their products.”
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