Cambrex licenses probes for microbiological QC

A Cambrex subsidiary has formed an alliance with Epoch Biosciences to apply a technology usually applied in genomic analysis to microbiological quality control for manufacturing processes.

Cambrex Bioproducts has acquired a worldwide license to Epoch's MGB Eclipse Probe System technology into its rapid microbial detection testing products and services.

Epoch's analytical tools can be ued in the detection of microorganisms in a variety of settings, and the company has been trying of late to broaden their use into industrial settings, for example to help quality assurance professionals meet regulatory standards, and to guard against contamination of products due to equipment failure, manufacturing process error, deliberate sabotage or bioterrorism.

The accord with Cambrex is its second licensing deal in industrial quality control testing.

MGB Eclipse Probe Systems are probe and primer sets used for a variety of genetic analysis applications, such as gene expression profiling, SNP (singlke nucleotide polymorphism) analysis, and pathogen detection. The systems are compatible with existing real-time polymerase chain reaction (PCR) instruments and reagent systems.

Cambrex said Epoch's technology will enable the company to build upon its endotoxin detection and mycoplasma screening testing platforms. It plans to develop new products for rapid microbial detection that will help "cell therapy and biologics customers … to meet the aims and objectives of the FDA's Process Analytical Technology (PAT) initiative."

PAT relies on the use of real-time, in-process measurements, to pick up problems early in the production process, allowing remedial action to be swiftly taken and preventing wastage.

Under the license and supply agreement, Cambrex receives a non-exclusive license to MGB Eclipse technologies and an exclusive license to probe sequences developed for specific patented primer sequences supplied by Cambrex.

Epoch will receive an upfront payment for technology access, product sales from shipments of MGB Eclipse probes and primers to Cambrex, royalties on Cambrex's sales of testing systems and services to end-users, and contract development revenue for specific product optimisation. Other financial terms were not disclosed.