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Clinical to Commercial Supply
Lonza’s facility in Portsmouth, New Hampshire is located approximately 60 miles north of Boston, Massachusetts on the East Coast of the United States. Portsmouth is a Seaport town with Lonza being the 5th largest employer in the city.
This clinical to commercial multi-product manufacturing facility specializes in custom production of mammalian biotherapeutics. The Portsmouth facility has been designed specifically for the production of therapeutic proteins derived from mammalian cell culture using deep tank fermentation systems. This facility houses mid-scale (5,000L) and large scale (20,000L) reactors for maximum flexibility.
Lonza has incorporated over 20 years of manufacturing experience into the design of the Portsmouth facility. Close contact with the regulatory authorities and consultants has led to a design that provides customers with the confidence that their products are being manufactured to cGMP standards.
Since 2001 the Portsmouth facility has hosted 33 regulatory inspections by FDA, EMA, Health Canada, Japan, Brazil, Mexico, the Korean FDA and the Turkish MOH. Lonza's Portsmouth facility is currently approved for 8 customer products. The facility design minimizes downtime, which maximizes throughput and provides customers with economically viable, long-term production.
The contract manufacture of biopharmaceutical products is Lonza' s core business. In order to ensure continued availability of cGMP manufacturing capacity, for new customers and for existing customers with expanding markets, Lonza continues to expand the Portsmouth site. Additional commercial-scale reactors came on line in 2004 and 2006. In late 2006, Lonza upgraded and added additional mid-scale airlift fermenter suites to meet growing demand at this scale. In 2007, Lonza broke ground in Portsmouth on a 315,000 square foot facility expansion. The first phase of this expansion when built out could house an additional mid-scale fermenter and high-titer purification capabilities.