Biologics demand drives Charles River lab ops transfer in Pennsylvania
The contract research organization (CRO) will move most Pennsylvania-based laboratory operations conducted at current facilities in Malvern and King of Prussia to the new Devon Park site, which it expect to open in early Q3, 2018.
Devon Park is located in Wayne, PA – eight miles from Charles River’s Malvern site – and houses more than double the laboratory space than Charles River’s Malvern and Kind of Prussia.
Charles River Laboratories on biologics: Testing or manufacturing?
The CRO provides “testing and manufacturing services to support clients throughout the development cycle of biologics, from discovery through preclinical and clinical studies to marketed product release,” said Greg Beattie, corporate vice president, global biologics testing solutions.
“Support we provide includes contamination and impurity testing, bioactivity and potency testing, anti-infective and vaccine challenge studies, lot and final drug product release testing, protein characterization, cell line characterization, manufacturing and production, stability testing and viral clearance studies,” he told us.
The facility will also accommodate dedicated suites for viral clearance studies.
“The increased capacity will not only improve timelines but will also provide opportunities to expand capabilities and enhance material flow and efficiencies,” said Charles River in a statement.
“In addition, the consolidation of testing and viral clearance activities at one site reduces the need for clients to conduct multiple quality audits,” it added.
Manufacturing operations will continue at Malvern – where Charles River is expanding clean room facilities to support cell and viral banking capacity.
From outsourcing to in-house
Last week, CEO Jim Foster told investors the firm requires additional capacity to meet increased outsourcing demand.
“As biotech companies proliferate and pharma companies increasingly rely on outsourced services to improve efficiency and access to expertise, they no longer maintain in-house.”
According to Foster, the number of biologic and biosimilar drugs in development has led to a growing demand for services, “especially in view of the fact that many of the biologic drugs are being developed by biotech companies that do not have the internal infrastructure to support the manufacture.”
The increased capacity in Wayne – along with an expansion of biologics services – “will further enhance our ability to support our clients’ biologic and biosmilar development efforts from discovery through clinical phases and commercial manufacturing,” Foster told investors.
A Charles River spokesperson told us the firm will release more information on this move at the end of this month.
