MDS Pharma Services Adopts Innovative Technology For Bioanalysis
King Of Prussia, PA - MDS Pharma Services, a leading provider of innovative drug discovery and development solutions, now offers its bioanalysis clients the benefits of electrochemiluminescent assay (ECLA) testing, with the recent installation and validation of two state-of-the-art instruments at its laboratory in Montreal.
In many situations, ECLA test methodology provides greater sensitivity and flexibility than standard radioimmunoassays or ELISA techniques for quantitative pharmacokinetic and immunogenicity testing of biological samples from clinical research participants.
These advantages are particularly important in research involving biologics such as monoclonal antibodies because traditional methodologies may not be capable of detecting anti-drug antibodies in the presence of circulating drug. Biologic drugs are made using living cells rather than chemicals and therefore have the potential to trigger a potentially harmful immune response.
"With the growing focus on biologic drugs, including biologic generics, the need to detect immune responses during clinical research becomes increasingly important," said MDS Pharma Services President David Spaight. "That's why MDS Pharma Services has added ECLA testing to our bioanalytical testing repertoire of ligand binding and cell-based assays."
MDS Pharma Services is developing ECLA assays for bone and metabolic biomarkers to leverage the instruments' multiplexing capabilities, which allow for measurement of multiple analytes or markers in a single test sample. This multiplexing ability offers clients increased productivity in keeping with MDS Pharma Services' brand promise to deliver high-quality results on time.
To accelerate client access to the benefits of ECLA methodology, MDS Pharma Services fast-tracked the validation of the two instruments and associated software, redeploying resources to complete the validation process. The instruments and software meet all applicable regulatory requirements, including 21 CFR Part 11.
SOURCE: MDS Pharma Services