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7 Apr 2020

CDMO Cambrex completes biopharmaceutical expansion at Durham, NC facility

Cambrex has completed an expansion of biopharmaceutical analysis capabilities at its Durham, North Carolina site, the contract development and manufacturing organisation said Tuesday.

The site now features a range of new instruments, including particle analysis, imaging, qPCR, fluorescent/absorbance plate reader, immunoblotting, mass spectrometry and other compendial testing apparatus, Cambrex said.

The new cGMP-compliant capabilities are applicable to a broad variety of biopharmaceuticals, including bacteriophage/bacterial virus and mammalian viral infectious titer assays for intermediates, drug substances, and final drug products.

“The expansion began in response to a customer request to support a BioSafety Level 1 (BSL1) organism and grew from there based on broader customer response,” said Elliott Franco, Durham Site Director, Cambrex.

Existing safety and containment practices for BSL1 and BSL2, and some BSL2+, at the Durham site allow support for a wide range of active ingredients.

Biopharmaceutical analysis services were initially launched at Durham in 2018 and have since been expanded through various method development, validation, release and stability or endotoxin testing functions.

Ongoing assay additions are also planned at Durham, including impedance-based orthogonal methods for existing and new cell-based potency assays, and protein-protein interaction/binding assays.

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