Lonza said today it will expand its mid-scale biologics manufacturing capacity as part of an expansion of its Portsmouth, NH, site set to begin later this year.
The cost of the expansion was not disclosed.
Lonza said it will install “multiple” mid-scale 6000-L bioreactors, as well as “multiple” cell-therapy suites at the Portsmouth site, in order to meet the needs of new and existing customers seeking reliable delivery of new treatments.
The Portsmouth expansion, according to Lonza, will give customers access to facilities enabling Phase I through commercial manufacturing under one roof. The expansion will focus strongly on automation, the company said, with plans to implement full-suite process analytic technology and advanced multivariate analysis to ensure consistent performance.
The hybrid facility—which will also incorporate single-use technologies for simplified processing—will be installed in an existing building and will be fully operational by late 2018.
“These new facilities have been designed specifically to deliver for our customers and their patients,” Marc Funk, COO Lonza Pharma & Biotech, said in a statement. “They will be enabled by cutting-edge technology developed with our R&D team and the decades of expertise at our Portsmouth site.”
Lonza says it considers expansion of mid-scale capacity a key area of growth, due to factors that include a more favorable regulatory environment for developing products for niche indications. Lonza said its Portsmouth site was an ideal location for adding mid-scale capacity to a global network that ranges from small, single-use bioreactors to large-scale facilities.
Acquired in 1996
Lonza acquired the Portsmouth site in 1996 when it bought Celltech Biologics, a deal that expanded the buyer into the business of producing therapeutic proteins derived from mammalian cell culture using deep-tank fermentation systems, as Lonza established the site as its first custom manufacturing facility for biologics.
The Portsmouth site has been expanded several times, growing into an 813,000-square-foot facility—most recently through completion of a 50,000-square-foot expansion and retrofit that included new modular process cleanroom suites for large-scale biologics. The site’s facilities include three mid-scale (5000-L) airlift reactors and four large-scale (20,000-L) stirred reactors, as well as associated purification suites.
Lonza designated the Portsmouth site, and its site in Singapore, as both clinical and commercial manufacturing sites on February 14, as part of its effort to establish four “Centers of Excellence for Cell and Gene Therapy” worldwide. Through those Centers, Lonza aims to accelerate growth in cell and gene therapy—a key pillar of the company’s strategy for developing new treatments.
The other two Centers worldwide are Lonza’s Houston Center of Excellence in suburban Pearland, TX, which officially opened in April, and the company’s site in Geleen/Maastricht, The Netherlands. Both offer a fully integrated range of cell- and gene-therapy services, including process and analytical development, clinical product supply, and commercial product supply, according to Lonza.
Lonza is shifting cell-therapy operations out of Walkersville, MD, enabling that site to focus entirely on the Bioscience Solutions business.