Expansion Activity of CMOs - Pharmaceutical Technology

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Expansion Activity of CMOs
The outlook is fairly optimistic as contract manufacturing organizations (CMOs) gather at CPhI Worldwide in Frankfurt. CMOs are expanding capacity for small-molecules, biologics, and finished-product manufacturing.


Pharmaceutical Technology



IMAGES COURTESY OF SAFC. BACKGROUND MOLECULES: CHAD BAKER/GETTY IMAGES
While contract manufacturers of active pharmaceutical ingredients (APIs), pharmaceutical intermediates, and finished products gather for CPhI Worldwide in Frankfurt later this month, the outlook for contract services is positive. Several large contract manufacturing organizations (CMOs) report healthy sales gains so far in 2008 and are proceeding with expansion plans in developmental and CGMP (current good manufacturing practices) capacity.

Lonza shows growth in small molecules and biologics

Lonza (Basel, Switzerland), one of the largest CMOs for small-molecule and biologics manufacturing, reported strong growth in the first half of 2008. Sales in its exclusive synthesis and biopharmaceuticals businesses increased 19.2% to CHF 765 million ($697 million) for the six-month period ending June 30, 2008. Capacity utilization in these businesses was approximately 90%, with a slightly higher level in biopharmaceuticals. The company also reported that restructuring measures initiated at its facilities in Baltimore, Maryland; Riverside, Pennsylvania; and Braine-l'Alleud, Belgium, facilities are all on track and contributed to improved profitability.

Exclusive synthesis. Led by gains in its small-molecule business, sales in Lonza's exclusive synthesis business increased to CHF 364 million ($331 million) in the six-month period ending June 30, 2008, up from CHF 242 million ($220 million) in the same period of 2007. The company is proceeding with several expansions. A small-scale, multipurpose CGMP API plant in Nansha, China, completed additional product validations during the first half of 2008. Construction of a corresponding large-scale API plant in Nansha is on schedule, and Phase I is expected to be completed in the second half of 2008. Further expansion phases in Nansha are in the planning stage, according to the company.

Lonza also expanded its technology portfolio with the addition of commercial-scale antibody drug conjugate capabilities and successfully completed commercial CGMP batches. The commercial-scale capabilities complement laboratory-scale and small-scale pilot-plant capabilities. Lonza is also expanding its fine-chemicals complex in Visp, Switzerland, for large-scale production of high-potency APIs (HPAPIs).

Biopharmaceuticals. Based on increased demand for mid-scale microbial manufacturing capacity, Lonza is expanding its microbial production facility in Hopkinton, Massachusetts, with the addition of a high-titer 2000-L manufacturing train. The new plant is scheduled to come on stream in March 2009. Lonza brought on line two large-scale microbial lines (15,000 L) at the company's Visp, facility, in 2007, and the lines are now fully operational.

In May 2007, Lonza broke ground for a facility for biopharmaceutical manufacturing technologies, support systems, and warehouses in Portsmouth, New Hampshire, where the company has large-scale mammalian cell-culture manufacturing capabilities. Lonza also added a 5000-L bioreactor to the existing facility. The company added a 500-L train at its mammalian manufacturing facility in Slough, England. Lonza began construction for a second large-scale mammalian facility in Singapore in 2007. The facility is scheduled to be completed and fully operational in 2011. A second large-scale mammalian manufacturing facility is scheduled for completion and operation in 2009.

Revised strategy. Lonza says it is expanding its contract- manufacturing business model to accommodate "pipeline agreements," in which the company and its pharmaceutical and biotechnology clients have the option to jointly develop and manufacture a pipeline of both chemical and biological products, an expansion from single-product agreements. Also, to focus on high-value-adding steps, the company is evaluating its outsourcing activities for low-value starting materials and intermediates.


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