The challenge  The sponsor asked us to develop and validate an electrochemiluminescence (ECL) ligand binding assay (LBA) to detect anti-drug antibodies (ADA) in human serum to support clinical studies. The therapeutic is a bispecific conjugated fusion protein with two functional domains, FD1 and FD2. Furthermore, FD1 has significant homology…

In previous blogs, we have discussed how flow cytometry can be used to identify both rare and abundant cell populations. Beyond characterization, these technologies can also be used to isolate specific cell populations for downstream applications such as functional testing, genomic analysis, cell therapy development, and biomarker research. …

Selecting a bioanalytical CRO is an important decision in drug development, but the process begins well before proposals arrive. A well-structured request for proposal (RFP) gives a CRO the scientific and operational context they need to develop an accurate proposal. You may know what you need the data…

When a sponsor’s biologic program expanded from a domestic Phase 1 design into a multi-region trial spanning New Zealand, EMEA, and APAC, the bioanalytical challenge centered on keeping a fragile, time-sensitive sample chain intact across nine additional clinical sites, two outsourced processing labs, and a central analytical lab, all…

Here is a scenario we encounter regularly. A sponsor has a promising biologic, a T cell-engaging bispecific, a Treg-depleting antibody, or a checkpoint inhibitor with a novel target. The tox species are cynomolgus macaque, minipig, or dog. And the clinical team wants to know: what will we actually see…