Lonza to manufacture Alector’s mAb drug candidates for Ph I trial

By Maggie Lynch

- Last updated on GMT

(Image: Getty/mirror-images)
(Image: Getty/mirror-images)

Related tags Lonza Alector Monoclonal antibodies Manufacturing Early phase Clinical development Neurology

Lonza will provide manufacturing for Alector’s Phase I drug candidates for neurodegenerative diseases from its Switzerland site, which is expected to be operational by mid-2020.

Alector selected Lonza’s Ibex Develop a contract development and manufacturing organization (CDMO) service for the manufacturing of two of its neurodegenerative disease drug candidates in clinical development. The two companies have been collaborating on the early phase development of Alector’s candidates since 2016.

According to a spokesperson for Lonza, the drug candidates are monoclonal antibodies (mAbs) that target the immune system for the treatment of neurodegenerative diseases. The spokesperson added that this approach differs from the current approach of targeting the toxic proteins associated with pathology, such as Tau and beta-amyloid.

Lonza’s GS Xceed gene expression system was used in this collaboration to create high-producing cell lines. Additionally, the two companies have worked together for clinical manufacturing of drug substance and drug product across the Lonza network.

Alector will use the Ibex Develop offering from Lonza which encompasses CDMO services throughout a biopharmaceutical’s life cycle. The Lonza spokesperson told us that Alector will have access to its regulatory team to ensure that its biologics license agreement (BLA) submission is ‘de-risked’ as fast as possible.

Per the agreement, Alector can move molecules for its pipeline in and out of production in accordance with the pace of its clinical trials to ensure the required supply is available.

Lonza will provide its Ibex Develop service out of its Visp, Switzerland site, which is currently undergoing development and is expected to be operational by mid-2020. The company plans to start operations for Alector in Q3 of 2020.

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