Assay Streamlining, Benefits, and Drawbacks
As a biopharmaceutical company matures and new products are added to its portfolio, expansion of its facilities, systems, and quality control is a natural outcome. The growth in the quality control area most certainly is coupled not only with additional analysts and samples but with also the addition of new assays required for the proper validation and verification of the new and existing processes. Once those quality control assays and methods are initially validated, there is very little impetus to revisit and improve them no matter how cumbersome, finicky, and outdated they may be. The costs of not seeking to streamline is that quality control assays and methods retain long and tedious steps allowing for mistakes and wasted analyst time. Moreover, by persisting with outdated technology, the robustness of one’s result can be questioned. The application of a little sound science and some design of experiments may lead the quality control department of a biopharmaceutical manufacturing site to some definite gains in sample through-put and efficiency.