Lonza Opens Monoplant for Clovis Oncology’s Rubraca

Clovis Oncology Inc. and Lonza announced the opening of a new, dedicated production train for Rubraca (rucaparib), Clovis’ US- and EU-approved drug for several ovarian cancer indications, at Lonza’s Visp, Switzerland site, the companies stated in an Oct. 4, 2018 press release. 

Under a long-term agreement, the new, state-of-the-art monoplant enables security of supply and flexibility to rapidly meet changes in market demand for rucaparib. During construction of the Clovis monoplant, Lonza manufactured rucaparib in its existing production trains at Visp, providing Clovis dedicated and uninterrupted access to capacity. 

The new production train for rucaparib includes extensive automation and on-line analytical monitoring designed to enable real-time release testing. This approach facilitates process monitoring and consistency and gives Clovis Oncology faster and agile delivery, with optimized cost of goods, according to the companies.

“This partnership is a great example of how we can support commercial-stage biotech companies through innovation in manufacturing technology and flexible business models,” said Marc Funk, COO Lonza Pharma & Biotech, in the press release. “Lonza continues to invest in infrastructure for the safe and efficient production of highly potent active pharmaceutical ingredients (HPAPIs).”

“Rubraca offers a new treatment option for women with recurrent ovarian cancer, and in addition we are exploring Rubraca in other indications, including prostate and bladder cancer, where Rubraca may offer additional treatment options for patients in need,” stated Patrick Mahaffy, CEO and president of Clovis Oncology, in the press release. “Our partnership with Lonza and the opening of this dedicated facility should allow the continued availability of Rubraca to patients who may benefit from its use, now and in the future.”

Source: Lonza