MDS expands bioanalysis services
testing services with the addition of electrochemiluminescent assay
(ECLA) capability, used to test biological samples from clinical
research participants.
The company recently installed and validated two ECLA instruments, which use light-emitting reagents to detect the presence of biological substances, 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," commented MDS Pharma. It has been well-established the ECLA is much more sensitive than ELISA, a factor that is particularly important when identifying highly active substances. For example, it is sometimes used in favour of ELISA to detect botulinum toxins, as it is two to four times more sensitive and the tests are quicker to carry out. MDS Pharma said 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. Those anti-drug antibodies can be important because they can cause an immunological reaction to the treatment, as well as neutralising its effects. "With the growing focus on biologic drugs, including biologic generics, the need to detect immune responses during clinical research becomes increasingly important," commented MDS Pharma 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." The company says it is developing ECLA assays for bone and metabolic biomarkers for use with the new instruments. MDS Pharma has seen a recovery of its bioanalysis busiuness of late, after a difficult few years following an inspection of the company's two Canadian plants by the US Food and Drug Administration (FDA) in 2003. This found a range of problems with its pharmacokinetics testing procedures, including failure to identify and fix sources of contamination in bioanalytical tests, which measured drug levels in the blood of patients.
