Lee Newton Vice President & Business Unit Head, API Development & Manufacturing Lonza Pharma & Biotech

Lee Newton, Vice President, Business Unit Head, API Development & Manufacturing, Lonza Pharma & Biotech, gave an update on the company’s investments for development and manufacturing services for highly potent active pharmaceutical ingredients (HPAPIs) and for increased automation in small-molecule manufacturing at the DCAT Week ’19 Member Company Announcement Forum, which was held March 18, 2019, in New York.

Newton highlighted that from 2017 to 2020, Lonza will have invested more than CHF 100 million ($100 million) in small-molecule manufacturing capabilities in its site in Visp, Switzerland, the largest production site in the company. The investments center on HPAPIs and what Newton termed as “Manufacturing 4.0” to enhance automation and digitalization in its small-molecule manufacturing operations.

Newton said that the company has worked to increase its ability to handle and manufacture HPAPIs, which require specialized assets for safe handling and production due to their potency and potential toxicity. He noted industry growth for HPAPIs in oncology drug development and in more targeted therapies, including antibody drug conjugates (ADCs). He cited internal analysis indicating that more than half of new molecular entities require some form of specialized handling. He also cited market data that show that the outsourced HPAPI market is expected to grow by a compound annual growth rate of 10% between 2015 and 2023 compared with a 6% growth rate for the overall small-molecule segment.

Lonza’s second focus in its investment in small-molecule manufacturing is to advance automation and digitalization for improved efficiency and compliance. Newton says Lonza’s goal is next-level automation by improving manufacturing throughput by increasing facility automation and implementing manufacturing execution systems (MES) for better tracking from raw materials to finished goods. These investments are expected to yield increased reliability and process intensification resulting in lower manufacturing costs and improved compliance through reduction of human errors and deviation. “These advancements are just the beginning,” said Newton. “The future will likely bring exciting manufacturing innovations such as virtual reality and real-time data sharing.”

Newton highlighted four major projects in HPAPI manufacturing and “Manufacturing 4.0”: a monoplant for flexible production of the API for the ovarian cancer therapy rucaparib for Clovis Oncology; a commercial-scale facility for ADC warhead manufacturing; two large-scale expansions for HPAPI manufacturing; and upgrades to its next-level automation capabilities.