Advion has added extra mass spectrometry and liquid chromatography capacity at its laboratory in Ithaca, New York and will “align an increased commitment of staffing” to its biomarker service.
Stephen Lowes, Advion's senior VP of science, told Outsourcing-pharma that: “There is a rapidly growing interest in biomarker assays. To date, these are typically served by ligand binding immunoassay methods - a service that Advion also provides separate from the LC/MS Biomarker service.
“Increasingly however, the definitive quantitation capabilities of LC/MS/MS are being sought and evaluated by pharmaceutical companies. At this point, only a few labs have established their LC/MS biomarker services presumably because of the unique analytical challenges many biomarker compounds present.”
These challenges, Dr Lowes explained, include things like the endogenous presence of analyte in control matrices, the lack of regulatory guidance and typical “large molecule” nature of many markers of interest.
He said that Advion will provide clients with “quantitative analysis supported by regulatory standard method validation data and fit-for-purpose assay development,” adding that at this stage the firm has no plans to work with other CROs.
Market competition
While the technical challenges of LC/MS may have dissuaded some CROs from entering the market, for others the growing level of pharma industry demand has proved impossible to resist.
In the last week alone, Aushon BioSystems and Pacific Biometrics have both taken steps to bolster their respective offerings with additional laboratory capacity and investment funding.
Prior to that Clinical Research Laboratory (CRL) set up an analysis laboratory in collaboration with UK CRO Quotient Bioresearch, while Millipore expanded its European biomarker operations through the acquisition of BioAnaLab.
However, while competition in the biomarker services sector is heating up it is likely that pressure to improve R&D efficiency will mean that, for the medium term at least, pharmaceutical industry demand will continue to grow.