Lonza agreed to buy 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, according to company officials. 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 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 says it will continue to employ the 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,” notes Karen Fallen, head of mammalian and microbial development and manufacturing at 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.”