As contract manufacturers and pharmaceutical companies gather next month in Madrid for CPhI Worldwide, the large trade show
for pharmaceutical ingredients, a fundamental question is the health of the custom-synthesis market. "Lumpiness" is a phrase
often used to describe the financial state of contract manufacturing, which is subject to the vicissitudes of drug development.
This term aptly describes the fortunes of the market this year. First-half results were mixed, with some players reporting
a sales decline, and others reporting positive results and expansion plans.
Patricia Van Arnum
Charting a bellwether
Lonza (Basel, Switzerland), one of the largest contract API manufacturers, reported a sales decline of 7.7% to CHF 706 million
($662 million) in its custom-manufacturing business (exclusive synthesis and biopharmaceuticals) for the first half of 2009,
according to the company's financial results. In its exclusive synthesis business, stronger sales in peptides and biochemicals
offset declines in small molecules. On the plus side, the company's capacity utilization was above 80%, with a pipeline of
225 projects, up from 185 in the first half of 2008.
Lonza is proceeding with several expansions. The first build-out of its large-scale multipurpose current good manufacturing
practice (CGMP) active pharmaceutical ingredient (API) plant in Nansha, China, is operating. The second build-out of the plant
started up last month. The Nansha site houses administration, research and development (R&D), a kilo laboratory, and small-scale
and large-scale production. The installation of a mid-scale multipurpose CGMP API plant at Nansha is under evaluation.
Lonza is also evaluating the addition of another mid-scale plant for highly potent APIs at its facilities in Visp, Switzerland.
Last year, the company added large-scale production capacity for high-potency APIs in Visp as well as antibody-drug-conjugation
capabilities. Lonza also recently added a laboratory-scale peptide production plant in Nansha. The company is evaluating additional
CGMP laboratory-scale production capacity for peptides at its facilities.
(MAGES: ROSEMARY CALVERT, BRAND X PICTURES, DAVID GREENWOOD/GETTY IMAGES ILLUSTRATION: M.MCEVOY)
Lonza is on track with two large-scale mammalian biopharmaceuticals expansions. The company is building a new biopharmaceutical
manufacturing facility in Singapore, which is expected to start up in 2011. Another biopharmaceutical plant in Singapore was
recently completed and will be ready to hand over to Roche (Basel, Switzerland) in the third quarter of 2009. In 2006, Lonza
and Genentech (South San Francisco, CA) formed an agreement providing Genentech the option to purchase Lonza's first Singapore
facility. Genentech was acquired by Roche earlier this year. In addition, Lonza is investing CHF 30 million ($28 million)
for the first phase of a new cell-therapy facility in Singapore, which will be adjacent to the company's large-scale mammalian
manufacturing facility. Construction is expected to begin early next year and be operational in mid-2011.
Lonza also reported that its retrofitted, multiproduct facility in Porriño, Spain, is fully operational and is supporting
three customer projects (Phase III and commercial scales). Lonza acquired the mid-scale mammalian biopharmaceutical production
plant in Porriño from Genentech in 2006. A new 5000-L line at its biopharmaceutical facility in Portsmouth, New Hampshire,
also recently went on stream.
Adding large-scale API capacity in US
Cambridge Major Laboratories (CML, Germantown, WI) dedicated a new 125,000-ft2 large-scale API manufacturing facility in Germantown, Wisconsin, in late July. The facility is designed with six GMP suites
capable of producing multiton quantities of APIs and advanced intermediates. The installed capacity is 70 m3 with an expansion capability for an additional 120 m3 .
CML says the new facility is part of its strategy to be a leading Western-based supply option. "Without this site, we would
never be considered for large-scale commercial manufacturing," said Michael W. Major, president and CEO of CML, in a July
20, 2009 company press release. "By default, those processes that our chemists developed and produced at smaller scale would
be lost to other Western competitors or offshore suppliers as the need for large-scale manufacturing arises. This new facility
eliminates those concerns."
The new facility follows recent multimillion dollar investments at the company's development facilities in Europe, which includes
new R&D and analytical laboratories and additional pilot-plant capacity. Those investments will add more than 40% to CML-Europe's
capacity and enable the facility to produce up to hundreds of kilograms and APIs and intermediates.