Chemical and Microbial Manufacturing
Lonza’s Chemical and Microbial Manufacturing (CMM) business offers contract manufacturing services for three technologies: small molecules, peptides and microbials. The peptides business was sold in January 2017. Now CMM operates from nine plants in two locations, Visp (CH) and Nansha (CN), with a customer base that is a healthy mixture of large, mid-size and emerging pharmaceutical companies.
Lonza has one of the widest breadths of expertise in the production of highly potent active pharmaceutical ingredients (HPAPIs) within the contract manufacturing organization (CMO) industry. This expertise spans highly skilled teams, state-of-the-art facilities and experience of more than 15 years in successfully commercializing HPAPI products. For the production of other active pharmaceutical ingredients (APIs), Lonza’s breadth and economy of scale, our many years of experience in launch and long-term manufacture, and the dedication of our personnel ensure that Lonza remains a leader in small-molecule contract manufacturing.
CMM supports the launch of three New Chemical Entities (NCEs) on average every year, and the small molecules team is heavily involved in U.S. Food and Drug Administration- (FDA-) designated breakthrough therapies, with a significant number of these products being produced at Lonza. These products are notable for the speed they need to reach the market, and Lonza receives excellent customer feedback on how these products are managed throughout the accelerated process.
CMM’s microbial assets underwent significant expansion in 2016. We expanded our offering at the 15,000L scale, not only in terms of capacity but also capability, such as specialized expertise for the handling of insoluble proteins. At the smaller scale, we also expanded capability in downstream manufacturing in the 1,000L scale asset.
In addition, CMM has a strong track record in supporting our customers with new and innovative business models. One example of note is a small-molecule HPAPI plant in Visp that supports launch of an NCE. The dedicated plant used for the API steps is supported by supply of an intermediate produced in our multipurpose plant, which gives both cost-of-goods and response-time advantages while giving our customer complete security of supply. CMM continues to develop such models in all technologies as we are well positioned to support such dedicated plants in our large and heavily back-integrated sites.
Chemical and Microbial Manufacturing Overview 2016
Our Chemical and Microbial Manufacturing business made considerable progress in 2016, further developing new business models and securing long-term commitments.
In October the strategic long-term manufacturing agreement with Clovis Oncology to secure supply of rucaparib was signed. The dedicated small-molecule manufacturing line to be constructed in Visp (CH) will be operational in 2019. This dedicated train guarantees access to manufacturing capacity for Clovis and allows coverage of the full range of anticipated demand scenarios for commercial supply.
As a result of the continuous review of Lonza’s business portfolio, it was decided in December to sell the peptide business and with it the Braine (BE) facility to PolyPeptides, a large, focused competitor in this field. The peptides chemical business was a niche business for Lonza with only limited synergies with our other small-molecule technologies.
For further information about Chemical and Microbial Manufacturing service offerings in Small Molecules, Peptides and Microbial, including our expertise in HPAPI, specialized technologies such as GMP Phosgenation & Carbonylation, MicroReactor Technology, HPAPI, Solid Phase Peptide Synthesis, Microbial Fermentation, Handling of Insoluble Proteins and Innovative Business Models, click on our Chemical Manufacturing website or our Microbial Manufacturing website.