The purchase of the Stein facility by the Swiss biotech will be complete within the next few months and will offer end-to-end service to its customers for clinical supply and launch, according to Lonza. It will be the first sterile drug product fill-finish facility in the company’s network.
The Stein facility will be incorporated into Lonza’s offering to give pharma customers immediate access to its full range of development, testing, and manufacturing services for parenterally administered medicines. Hanns-Christian Mahler, head of drug product services at Lonza told us, "In 2016 we started to build up early phase drug product development for parenterals, and this new acquisition now means we can support customers through to commercial launch and some niche commercial products."
Currently, the facility serves as Novartis’ Center of Excellence for sterile clinical drug product manufacture and is current good manufacturing practice (cGMP) approved. Initiating operations in 2009, the facility includes a classified cleanroom for cGMP manufacturing as well as office, lab, utilities, and storage space.
The facility will continue to perform sterile manufacturing of liquid and lyophilized dosage forms for up to 200L bulk volumes for clinical supply and commercial launch. Mahler said that the facility will also be able to provide sterile fill and finish for vials and the company will be adding capabilities for filling syringes in the near future. Additionally, the facility can provide sterile manufacturing for biologics as well as small molecule parenterals.
Lonza will produce drug product at the facility for Novartis while still providing capacity for additional customers.
The facility will retain the team on site, and because of that Mahler hopes it will be operational shortly after the closing within the next few months.
Since 2016, Lonza announced expansions at its sites in Basel and Visp, Switzerland and stated that it will expand development and testing labs into a larger building in Basel in 2020. It expects its Ibex Solutions fill and finish facility in Visp to be operation from mid-2021.