Australian contract research organisation CPR Pharma Services has expanded its bioanalytical offering in the Asia Pacific (APAC) region by launching a ligand-binding assay service for large molecules such as monoclonal antibodies, biosimilars and biologics in early- or late-phase clinical trials.
Around a year ago, CPR opened what it said was the first Good Laboratory Practice-standard bioanalytical laboratory in Singapore, enabling US and European companies to fast-track clinical trials previously hamstrung by a shortage of regulated GLP laboratories to handle bioanalytical samples in Asia.
According to chief executive officer Jason Valentine, the new large-molecule laboratory in Adelaide, Australia now makes CPR the first APAC-based laboratory to offer such an extensive range of GLP services.
The Large Molecule Immunochemistry Analytical Service will be run by John Chappell, who brings to CPR a wealth of experience in ligand binding-assay development, validation and implementation for clinical trials.
Chappell is a member of the American Association of Pharmaceutical Scientists committee currently preparing white papers on biosimilar bioanalytical support, CPR noted.
He has also worked for more than 20 years with CROs such as Covance, ClinTrials BioResearch, BAS Analytics, Veeda and ICON.
As Valentine pointed out, monoclonal antibodies, proteins, biologics and biosimilars account for a growing share of the drug development effort worldwide.
“Couple this with the increased emphasis on biomarker monitoring in clinical trials and large-molecule quantification is critical to any modern bioanalysis laboratory,” he said.
CPR had held off on moving into the space, though, until it had found the human resources to “do justice to our philosophy to only offer services when we have industry leading expertise”, Valentine added .
“CPR now has that expertise in John Chappell, who has commenced building a world class team within our Adelaide laboratory.”
Its Large Molecule Immunochemistry Analytical Service puts CPR “in a unique position as the only company in Australia to offer the full compliment of assay development service combined with standard CRO services”, Valentine noted.