Lonza to buy sterile drug product fill-finish facility from Novartis

Swiss CDMO bids to keep management and operations teams and manufacture for Novartis at the site in Stein

Swiss CDMO Lonza is set to add its first sterile drug product fill and finish facility to its Drug Product Services (DPS) following a binding contractual commitment with drug maker Novartis.

Located in Stein, some 50-minute drive northwest Zurich to the border of Germany, the manufacturing plant will enable Lonza Pharma & Biotech to build on existing parenteral drug product development and testing capabilities and offer an end-to-end service to its customers for clinical supply and launch.

The sterile, multi-product facility currently serves as the Novartis Center of Excellence for sterile clinical (phases 1 to 3) drug product manufacture. The facility, Lonza said, has an excellent quality and safety track record and is cGMP approved.

“The intended acquisition of the sterile drug product fill and finish facility in Stein will be the latest phase in our step-wise expansion of parenteral drug product services," said Karen Fallen, Head of Mammalian and Microbial Development and Manufacturing, Lonza Pharma & Biotech. "Combined with our development services, this manufacturing facility will provide our customers with shorter timelines to the clinic and best-in-class quality for parenteral product development through commercialization," she added.

Following closing—expected to take place within the coming months— Lonza will produce drug product at the facility for Novartis as well as providing capacity for additional customers.

Site specs

Operational since 2009, the facility includes classified cleanroom areas for cGMP manufacture as well as office, lab space, utilities and storage.

The facility in Stein will continue to perform sterile manufacturing including liquid and lyophilised dosage forms for up to 200L bulk volumes for clinical supply and commercial launch.

Lonza said it will continue to employ the experienced team at the facility.

Market potential

The Swiss CDMO launched Lonza Pharma & Biotech in 2016 to cater to drug product development services. Due to increasing demand from the market, Lonza has embarked on expansions at its sites in Basel and Visp.

Lonza said that from 2020, the group will expand development and testing labs into a larger building in Basel and expects its Ibex Solutions fill and finish facility in Visp to be operational from mid-2021.

The new facility in Stein will be fully incorporated into Lonza’s offering and will give pharma and biotech customers immediate access to the full range of development, testing and manufacturing services for parenterally administered medicines.

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