Strong market demand for our Bioscience technologies continued in 2017, notably the cell biology, transfection, bio-therapeutic media and endotoxin product portfolios.
The reporting year saw the launch of five new products:
- Idiopathic pulmonary fibrosis (IPF) lung fibroblasts – to support research for treatment of IPF, a rare non-neoplastic pulmonary disease affecting approximately 5 million people worldwide. This release further expanded our airway disease portfolio, which also incorporates cells from asthma, chronic obstructive pulmonary disease (COPD) and cystic fibrosis donors, supporting some of the most important areas in respiratory research.
- Irradiated mouse-embryonic fibroblasts (iMEF) – an inactivated form of MEF cells that can be used to support some stem-cell cultures.
- CytoSMART™ 2 System, an upgrade of Lonza’s popular system for affordable live-cell imaging and cell-culture monitoring.
- A new release of MODA-EM™ (Version 3.3) – quality-control tools for environmental monitoring or cleanrooms to facilitate compliance with data integrity requirements, while delivering better analytics and reporting.
- Silensomes™ HLM – pooled human liver microsomes (HLM) for in-vitro cytochrome P450 (CYP) phenotyping. HLMs are used to support qualitative and quantitative CYP phenotyping methods requested by regulatory agencies for drug metabolism and drug-drug interactions.
In May Lonza acquired HansaBioMed Life Sciences, based in Tallinn (EE) and invested in Exosomics Siena, an Italian start-up. These investments reinforced our platform for developing next-generation research and therapeutic and diagnostic applications based on exosomes.
Bioscience Solutions experienced ongoing positive market demand in 2017; but remediation efforts related to the production of certain biotherapeutic liquid media products manufactured in one particular area of our Walkersville, MD (USA), site that is used to produce <20 L containers negatively affected the performance. We are addressing the issues affecting the Walkersville site with a comprehensive approach and continue to focus on our commitments to the FDA made in connection with the FDA warning letter Lonza Walkersville received in April 2017. As of November 2017 and on a rolling basis, we have begun to resume manufacturing in the area where it was previously suspended. First products were released in January 2018; other products have become gradually available as well. Production of research-use-only (RUO) and certain for-further-manufacturing (FFM) media products in other manufacturing lines in Walkersville and other global sites have been ongoing.