Lonza has entered an agreement to purchase a sterile drug product fill & finish facility from Novartis. The closing is expected to take place within the coming months. The new facility, in Stein, Switzerland 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. It will be the first sterile drug product fill and finish facility in Lonza’s network.
 
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 has an excellent quality and safety track record and is cGMP approved. Following closing, Lonza will produce drug product at the facility for Novartis as well as providing capacity for additional customers.
 
Operational since 2009 the facility includes classified cleanroom areas for cGMP manufacture as well as office, lab space, utilities and storage. The facility will continue to perform sterile manufacturing including liquid and lyophilized dosage forms for up to 200L bulk volumes for clinical supply and commercial launch. Lonza will continue to employ the highly experienced team at the facility.
 
“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.”
 
Hanns-Christian Mahler, head of drug products services, Lonza Pharma & Biotech, said, “Launched just three years ago with a core team of experts, Lonza DPS has since expanded in line with customer demand. Upon closing, the new manufacturing facility in Stein will be our first sterile drug product fill and finish facility and will work in close synergy with our existing facility in the Stücki Park in Basel. We will continue to provide best-in-class development and commercialization options for our customers, using our scientific approach together with our regulatory and industrial experience and to deliver with the highest quality standards.”
 
Since entering the field of drug product development services at the end of 2016, Lonza Pharma & Biotech has met considerable demand from the market and has already announced expansions at its sites in Basel and Visp, Switzerland. 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 on-track 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.