Publication / Source: Bioanalysis 3(9)
Authors: Kelley M
“Integral to the successful development of drugs are accurate and precise data. Reliable and robust analytical methods remain the basis for the reproducible quantification of therapeutic drugs in biological matrices…”
Is it not interesting that when an unforeseen event turns disastrous, or at least damaging, it has the ability to focus our attention on exactly those key issues that demand resolution? In fact, even the path to resolution becomes amazingly clear.
For example, throughout the 1990s, the bioanalytical community understood that it had to be aware and test for immune responses to protein drugs. Yet the process was vague and deciding which tests to perform was characterized by individual interpretation. When, after years on the market with no unexpected clinical sequelae, an erythropoiesis-stimulating protein formulation suddenly induced an immunogenic response, it did not take long before the tiered approach to testing for immunogenicity was described.