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Lonza will provide development and manufacturing services to two of Alector’s neurodegeneration drug candidates.
Lonza announced in a May 2, 2019 press release an agreement with Alector, a San Diego, CA-based clinical stage biopharmaceutical company focused on immuno-neurology, to secure manufacturing capacity for two of Alector’s drug candidates currently in Phase I development for neurodegenerative diseases.
Under the agreement, Alector will use Lonza’s Ibex Develop, part of Lonza’s Ibex Solutions offerings, to ensure drug supply and market readiness. Ibex Develop is based on flexible single-use technology that allows management of forecast volatility and scale-up or -out within the same facility or in the wider Lonza network. Alector will have the flexibility to move molecules from their pipeline in and out of production as needed, to match the pace of their clinical trials, and assure the quantities required are available.
In addition, Alector will be able to leverage Lonza’s experience in expedited regulatory pathways and in bringing biologics successfully through biologics license application submissions as well as the option of drug substance and drug product manufacturing under one roof. The facility, which offers Ibex Solutions and is located at Lonza’s site in Visp, Switzerland, will be operational from 2020 onward, with plans to start operations for Alector in the third quarter of 2020.
The two companies have been working together since 2016 on early phases of development for Alector’s lead candidates. Based on the potential product needs of these candidates, Lonza’s GS Xceed Gene Expression System was used to create high-producing cell lines. The programs have also included clinical manufacturing of drug substance and drug product across the Lonza network. Lonza states that Alector is now looking to secure supply for current and future trials with the ability to scale up rapidly.
”Lonza continues to be an innovator in the space and their flexible solutions and product offerings enable Alector to focus on drug development and bringing therapeutics to market to address the severe unmet need in neurodegeneration as efficiently as possible,” said Robert King, chief development officer, Alector, in a company press release. “Lonza’s considerable knowledge and experience make them an attractive long-term partner.”