Highlights 2017 Audited

The Clinical Development and Manufacturing business overall continued to perform strongly as we took advantage of sustained high demand for full-service CDMO development and manufacturing services. CDM service offerings were among the key drivers in the strong performance of the Lonza Pharma&Biotech segment in 2017, which followed robust revenue and profitability growth the previous year.

In 2017 we supported early-phase customers with their pre-clinical and clinical innovator molecules, followed by process development and clinical-phase manufacture, in all three of our product and service modalities: mammalian, microbial and chemical. Following the acquisition of Capsugel, Lonza is now able to offer integrated programs for clinical development that include Lonza’s drug substance offerings with drug product capabilities.

We expanded our mammalian manufacturing capacity in clinical development in our Slough (UK) facility, and we acquired a new site in the United States to support increased customer demand. In microbial we focused on strain development, process development, cGMP manufacture and process characterization work for late-stage programs. Our chemical technologies supported process development aimed at successful scale-up for commercial manufacture at our larger assets in Visp (CH).

In the reporting year, we experienced a significant increase in interest for our small-molecule containment capabilities, particularly for cytotoxic and highly potent active pharmaceutical ingredient (HPAPI) molecules.

The Drug Product Services (DPS) team in 2017 developed parenteral formulations for safe and efficient patient treatment across different types of molecules. That team provided a complete portfolio of services for parenteral dosage forms, including products for injection and infusion for intravenous, subcutaneous and intraocular routes of administration. These offerings also include specialized services, such as:

  • Particulate identification, characterization and quantification
  • Excipient and surfactant characterization
  • Extractables and leachables assessment
  • Container-closure integrity testing

To provide additional room for formulation, process development and specialized services, the floor space for Drug Product Services was tripled in 2017 to accommodate the demand.