Diagnostics Manufacturing: Strategies for Outsourcing

When new assays or diagnostic tests are ready for commercialization, there can be tremendous hurdles to overcome, including significant investment in the infrastructure for automated manufacturing and test equipment and hiring and retaining highly trained personnel, as well as implementing high-end quality management systems. In addition, FDA, ISO, GMP, and other approvals or certifications may be required. This article examines the requirements for manufacturing these complex diagnostics as well as the critical factors to consider when selecting a manufacturer.