News | July 1, 2019

Lonza To Acquire Sterile Fill And Finish Facility From Novartis

  • Facility in Stein (CH) will complement Lonza Pharma & Biotech’s current parenteral drug product offering in Basel (CH)
  • First facility for Lonza’s Drug Product Services (DPS) to cover sterile manufacturing for clinical production and commercial launches
  • Management and operations teams will be retained and Lonza will manufacture for Novartis at the facility

Quote from Karen Fallen, Head of Mammalian and Microbial Development and Manufacturing, Lonza Pharma & Biotech:
“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. 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.”

Quote from Hanns-Christian Mahler, Head of Drug Products Services, Lonza Pharma & Biotech:
“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.”

Lonza recently announced its entry into a binding contractual commitment for the purchase of 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 (CH) 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.

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(CH). From 2020 the group will expand development and testing labs into a larger building in Basel and expects its IbexTM Solutions fill and finish facilityin 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 biotechcustomers immediate access to the full range of development, testing and manufacturing services for parenterally administered medicines.

About Lonza Drug Product Services
The DPS team provides a holistic approach to drug product development that anticipates and prevents problems early and helps ensure the product is optimal for manufacture, supply chain and patient use. DPS delivers a complete portfolio of services for parenteral dosage forms including products for injection and infusion for intravenous, subcutaneous, and intraocular routes of administration. For more information, visit https://www.lonza.com/custom-manufacturing/biological-manufacturing/drug-product-services.aspx.

About Lonza
Lonza is an integrated solutions provider that creates value along the Healthcare Continuum. Through our Pharma Biotech & Nutrition segment and our Specialty Ingredients segment businesses, we harness science and technology to serve markets along this continuum. We focus on creating a healthy environment, promoting a healthier lifestyle and preventing illness through consumers' preventive healthcare, as well as improving patient healthcare by supporting our customers to deliver innovative medicines that help treat or even cure severe diseases.

Patients and consumers benefit from our ability to transfer our pharma know-how to the healthcare, hygiene and fast-moving consumer goods environment and to the preservation and protection of the world where we live.

Founded in 1897 in the Swiss Alps, Lonza today is a well-respected global company with more than 100 sites and offices and approximately 15,500 full-time employees worldwide at the end of 2018. The company generated sales of CHF 5.5 billion in 2018 with a CORE EBITDA of CHF 1.5 billion. For more information, visit www.lonza.com.

SOURCE: Lonza