Alector chooses Lonza platform for manufacturing scale-up

The companies have extended collaboration beyond the early phases to include using the Ibex Solutions platform for neurodegenerative disease drug candidates

Alector and Lonza have penned an agreement to secure manufacturing capacity for two of Alector’s drug candidates currently in Phase 1 development for neurodegenerative diseases. The California-based biotech has chosen the Swiss corporation’s Ibex Solutions to ensure drug supply and accelerate market-readiness.

The two companies have been working together since 2016 on the 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 programmes have also included clinical manufacturing of drug substance and drug product across the Lonza network. Alector is now looking to secure supply for current and future trials with the ability to scale up rapidly.

Karen Fallen, Head of Mammalian and Microbial Development and Manufacturing at Lonza, said: "With biotech customers like Alector who want to commercialise their drug candidate, we offer a rapid and simplified path to transition from clinical to launch which allows them to focus on bringing their therapies to patients.”

Clinical to Commercial

The Ibex Develop offering in Visp, Switzerland helps companies rapidly transition from clinical phase II to commercialisation. This was a compelling choice for Alector, who was looking for a simplified tech transfer from Lonza’s clinical assets in Slough (UK) and Hayward, CA (US) into a scalable solution with clinical and commercial production under the same roof.

Under the agreement, 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.

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.

In addition, Alector will be able to leverage Lonza’s experience in expedited regulatory pathways and in bringing biologics successfully through BLA submissions as well as the option of drug substance and drug product manufacturing under one roof.

The Visp, CH facility, from which Ibex Solutions is offered, will be operational from 2020 onward, with the planned start of operations for Alector in Q3 2020.

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