Gallus operates a Centre of Excellence for third-party process development (PD) and manufacture of biopharmaceuticals from its site in St. Louis, Missouri. The acquisition of Laureate is set to double PD capacity, adding full protein characterisation, testing and clinical fill-finish capabilities from a second site in Princeton, New Jersey.
“There is sufficient demand from clients for these services,” Gallus' CEO Mark Bamforth told Biopharma-Reporter.com and “Gallus expects to maintain and grow both facilities.”
Within the industry, he continued, “there is some consolidation of biologics focused contract manufacturing organisations (CMOs) with a limited number that have established commercial capabilities. It is part of Gallus’ strategy to look for opportunities for M&A that complement the strong organic growth at Gallus’ existing sites.”
Financial details of the acquisition have not been disclosed.
New Jersey to Missouri
Between the St. Louis and newly acquired Princeton facilities, the firm will use a mixture of single-use platforms and stainless steel bioreactors - including Thermo Scientific’s Hyclone and GE Healthcare’s Xcellerex (both single-use) - for manufacturing volumes between 50L and 2,000L.
Gallus will select the site most relevant to suit a client’s requirements, Bamforth told us.
“The St. Louis site has deep perfusion expertise so clients requiring perfusion technology would be best served from there,” he said, whilst “the Princeton site has deep experience handling more complex molecules, such as fusion proteins, so those would be best served from there.”
However, “there may be some clients’ whose needs involve activity at both sites, such as bulk production in St. Louis and clinical fill-finish at the Princeton site,” though “eventually, successful molecules will transfer to St. Louis for commercial bulk manufacturing.”
The 200,000sq ft St. Louis site was acquired by the newly formed CMO Gallus in 2011 from Centocor, and has approval from every major regulator. Last year the firm completed a $20m (€14.8m) expansion, doubling the size of the PD laboratories and equipping it to supply monoclonal antibodies for clinical trials.