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Clinical to Commercial Supply
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To meet our customers increasing demand for capacity, Lonza has commercial-scale, state-of-the-art cGMP manufacturing facilities in Portsmouth, New Hampshire, on the East Coast of the United States. The Portsmouth facility has been designed specifiaclly for the production of therapeutic proteins derived from mammalian cell culture using deep tank fermentation systems. This facility houses stirred tank as well as airlift reactors for maximum flexibility.
The facility has been custom designed as a multi-product facility for the manufacture of bulk purified therapeutic proteins for use in clinical studies and in-market supply. 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 21 regulatory inspections by FDA, EMEA, Health Canada, Japan, Brazil, and Mexico. Lonza's Portsmouth facility is currently approved for 6 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 comercial-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 will house mid-scale fermenter capacity and high-titer purification capabilities. The expansion will further strengthen Lonza’s position as the service provider of choice for the custom manufacturing of biopharmaceuticals. |
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