Increased biologics business demand drives Charles River expansions

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Charles River is expanding its biologics testing solutions in Pennsylvania with the addition of a new site on Devon Park in Wayne. (Getty/kasto80)

Charles River Laboratories is making a series of expansions to meet growing demand for its biologics services, including doubling its operations in Pennsylvania with the addition of a new facility.

The CRO will transfer all Pa.-based laboratory functions, except for cell banking and manufacturing, from two existing facilities in Malvern and King of Prussia to a new, 73,000-square-foot site on Devon Park in Wayne, which is expected to start operations in the third quarter.

Services offered at the new site include quality control and viral clearance, “where increased capacity will not only improve timelines but will also provide opportunities to expand capabilities and enhance material flow and efficiencies,” Greg Beattie, Charles River’s VP of global biologics testing solutions, told FierceCRO. “In addition, the consolidation of testing and viral clearance activities at one site reduces the need for clients to conduct multiple quality audits.”

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Manufacturing at the Malvern site will undergo its own expansion with the addition of 2,800 square feet of clean rooms to support increased demand for microbial and mammalian cell and viral banking capacity. The project will increase cell banking capacity at the site by 40%, as well as upgrade rooms for virus and vaccine production. The company is also adding capabilities for high-volume and high-density cell banks as alternatives to traditional formats.

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The company has recently added about 4,500 square feet of laboratory space to its Erkrath, Germany, facility to conduct bioactivity testing, including support for lot release, stability testing, accelerated stress condition testing and the comparability testing of biosimilar products.

Putting key capabilities offered in Malvern and Shrewsbury and Woburn, Mass., under one roof, Charles River recently designated the Shrewsbury site as the Analytical Center of Excellence, which offers similar services as the Erkrath site.

“This location will facilitate the continued expansion of our analytical and protein characterization services, which reflects the growing needs of the pharma and biotech community in and around the greater Boston area,” said Beattie.

Charles River’s recent devotion to biologics services could be traced back to its 2016 acquisition of Blue Stream Laboratories, an analytical CRO focused on the sector.

CEO Jim Foster told investors during the company’s 2017 earnings call in February that the company is seeing rapid increase in demand for its biologics services, as “many of the biologic drugs are being developed by biotech companies that do not have the internal infrastructure to support the manufacturer.”

The company reported double-digit organic revenue growth for its biologics business for fourth-quarter and full-year 2017, and expects it to grow at low double-digit rates in 2018, with the support of additional capacity.