Lonza has signed an agreement with AstraZeneca to manufacture AZD7442, a combination of two long-acting antibodies (LAABs) for the potential prevention and treatment of COVID-19. AZD7442 is currently in Phase I clinical studies and AstraZeneca plans to advance the LAAB combination into Phase 3 trials in the coming weeks.
 
The agreement enables AstraZeneca to leverage Lonza’s extensive antibody manufacturing expertise, as well as QC testing, regulatory competence, and experience with accelerated manufacturing campaigns.
 
Under the terms of the agreement, Lonza will manufacture drug substance (DS) for AZD7442 at Lonza’s facilities in Portsmouth (US).  Operations are expected to start in H1 2021.
 
AstraZeneca will be one of the first companies to access Lonza’s new mid-scale facilities in Portsmouth, NH (USA). With operations starting later this year, the new hybrid facility combines the cost efficiencies of mid-scale stainless steel bioreactors with disposable downstream technology for flexibility and speed. Automation and process analytic technology also open up the possibilities for real-time data sharing and transparency.
 
“Given the threats posed from the ongoing COVID-19 pandemic, advancing options for prevention and treatment are of crucial importance,” said Jean-Christophe Hyvert, chief commercial officer, Lonza. “Our team is extremely motivated to welcome AstraZeneca as one of the first projects in our new mid-scale facility in Portsmouth, NH. The new facility will provide AstraZeneca with the flexibility and the speed needed to manufacture AZD7442 on accelerated timelines.”