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A monoplant may offer greater supply security and flexibility for specialist medicines.
Editor's Note: This article was published in Pharmaceutical Technology Europe's March 2019 print issue.
In October 2018, Lonza and Clovis Oncology announced the opening of a dedicated facility for the production of Rubraca (rucaparib)-Clovis’ ovarian cancer drug that is approved in both the United States and European Union (1).
“We worked last year to open a ‘monoplant’ that served one of our customers, Clovis Oncology-rather than using a multi-purpose plant serving multiple customers,” says Maurits Janssen, head of commercial development, API Development & Manufacturing, Lonza Pharma & Biotech. “This approach offers a number of benefits, including extensive automatic on-line monitoring of the production designed to facilitate real-time release testing, and dedicated access to our existing production trains to bridge between campaigns. This particular production site is part of a long-term agreement for Lonza to develop product supply for Clovis’s ovarian cancer drug Rubraca (rucaparib).”
The new production train is based at Lonza’s Visp site in Switzerland and offers extensive automation and on-line analytical monitoring designed to enable real-time release testing. “The results to date have been encouraging, including a substantial cost of goods reduction compared to initial campaigns,” Janssen reveals. “Lead time from order to delivery has also fallen, from more than 24–36 months initially to only six weeks now.
Ultimately, the monoplant model means greater security of supply and flexibility to rapidly adapt to changes in market demands for specialty medicines such as rucaparib.”
1. Lonza, “Clovis Oncology and Lonza Celebrate Grand Opening of New Monoplant for Rubraca (rucaparib),” Press Release, 4 Oct. 2018.
Pharmaceutical Technology Europe
Vol. 31, No. 3
When referring to this article, please cite it as F. Thomas, “Monoplant: Advantages of a Dedicated Facility," Pharmaceutical Technology Europe 31 (3) 2019.