MilliporeSigma – the life sciences division of Germany’s Merck KGaA – has opened its €290 million ($300 million) facility in Rockville, Maryland, consolidating laboratories that were once spread across four buildings into an integrated hub.
Announced in November 2022, the contract development and manufacturing organization (CDMO) claims the site to be its largest biosafety testing investment historically. At the time of the announcement, the CDMO said the decision to expand is in response to the increasing global demand for such services.
“Our Rockville campus has a long track record of testing for both traditional and novel therapies. Approximately 870 people are currently employed at our Rockville site, and over the next several years, we expect to add 300 new jobs as part of this expansion,” a spokesperson for MilliporeSigma told BioProcess Insider.
“Our new site will also feature advanced testing capabilities, including a rapid methods package designed to accelerate virus testing of bulk harvest material, and the recently launched Aptegra platform, a validated genetic stability assay.”
The facility also includes advanced testing technology such as a rapid methods package to accelerate virus testing. The package includes a targeted molecular method for detecting virus families called Blazar CHO [Chinese hamster ovary] Animal Origin Free (AOF) panel. According to the firm, the facility will integrate the panel with assays for mycoplasma, sterility, and retrovirus-like particle detection to precure test results in 14 days, compared to the usual 35 days done with traditional assay methods.
“Rapid testing methods are of great interest to the industry, as they significantly reduce the bottleneck of bulk harvest lot release testing,” the spokesperson said. “With rapid testing methods, the time that products sit in warehouses while biopharma manufacturers wait for test results is drastically reduced, which in turn leads to improved facility utilization.”
“Through all stages of the biopharma development process, our leading GMP-compliant biosafety services and regulatory knowledge help biomanufacturers progress their therapeutic from discovery to release. Biosafety testing, analytical development, and viral clearance are critical and fundamental requirements of the drug development and commercialization process to ensure the safety of medicines.”
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