Lonza has expanded its growing presence in mammalian manufacturing by acquiring a clinical-stage site in Hayward, CA, from Shire for an undisclosed price.

The acquisition, completed yesterday, will add the Hayward site’s 1000-liter and 2000-liter single-use bioreactors and associated downstream capabilities to Lonza’s three 1000-liter single-use bioreactors at its mammalian development and manufacturing site in Slough, UK, focused on preclinical to early clinical supply.

“The site will significantly increase our single-use bioreactor capacity in the clinical development mammalian network,” Lonza spokeswoman Constance Ward told GEN.

The 58,000-square-foot Hayward site has operated as a multiproduct Current Good Manufacturing Practice (cGMP) facility since 1990. Shire inherited the Hayward site when it completed its $32 billion acquisition of Baxter spinout Baxalta in 2016.

“Shire continually reviews its product supply network to ensure we are operating efficiently and ready to meet the needs of our patients today and in the future. To this end, Shire has divested the Hayward, CA, manufacturing facility to Lonza, a highly regarded supplier to the life sciences industry,” Shire spokeswoman Katie Joyce told GEN.

The sale of Hayward does not signal a retreat from internal manufacturing, she added: “Our internal network is robust and includes multiple U.S. sites in Massachusetts, Georgia, and California, in addition to sites throughout the EU and in Singapore.”

More than 100 staffers are based at Hayward—all of whom will have the opportunity to continue in their positions, according to Lonza.

Lonza said the Hayward site will help satisfy growing demand by customers for clinical-stage manufacturing capacity—by adding early-phase clinical manufacturing based on the West Coast to supplement its existing mammalian manufacturing facility in Slough.

In addition to the single-use bioreactors, Slough also contains airlift bioreactors, one each of 200 liters and 2000 liters, a stirred bioreactor of 800 liters, associated purification suites, and process R&D services

Growing Sales

Lonza credits sales increases in commercial manufacturing of mammalian cell cultures as one of several factors behind a 27% jump in sales for its Pharma & Biotech segment, to CHF 1.064 billion ($1.093 billion) in the first half of 2017. The segment’s core earnings before interest and taxes from operating activities zoomed about 72% over January–June 2016, to CHF 273 million ($280.63 million)

In Hayward, Lonza’s first customer batches will be initiated during 2018, the company said.

“The acquisition of this site allows our customers greater access to clinical capacity from a U.S. site. The additional capacity will support the needs of our customers to secure manufacture for their products’ complete lifecycle across Lonza’s global manufacturing network,” Karen Fallen, VP, Business Unit Head, Clinical Development for Lonza, said in a statement.

In that statement, Matt Walker, Shire’s head of technical operations, added that Shire would partner with Lonza to manage the manufacture and supply of reagents used in a number of Shire products.

Lonza’s mammalian manufacturing presence is also being expanded through the addition of new facilities in:

  • Portsmouth, NH, where Ward said Lonza is ramping up a dedicated suite;
  • Singapore, where the company is adding single-use technology capacity at its Tuas site;
  • Visp, Switzerland, where Lonza has partnered with Sanofi to codevelop a large-scale mammalian cell culture facility for monoclonal antibody production through a 50–50 joint venture.

Last week, Lonza and Sanofi held a formal groundbreaking event celebrating the Visp facility, for which Sanofi and Lonza have agreed to invest an initial CHF 290 million (about $298 million).

Lonza’s acquisition of the Hayward site comes almost a year after the company signaled its intent to expand in manufacturing by acquiring Capsugel for $5.5 billion from private-equity firm KKR, in a deal completed July 5.

The Capsugel deal was designed to expand the market reach of Lonza’s contract development and manufacturing organization and products businesses—specifically by boosting Lonza's position in the consumer healthcare and nutrition sector through the provision of active ingredients, oral dosage forms, development services, and delivery technologies.

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