Ensuring Product Quality And Safety Through Process Optimization And Characterization

Successful manufacture of biologics is driven by fast, efficient production scale-up and consistent, high product quality. A well-characterized process is essential to achieve these goals, comprising a vital aspect of the later phase of process development (moving from clinical to commercial). Process characterization is concerned with understanding how process input variables influence the end product relative to critical quality attributes (CQA), as well as ensuring manufacturing process robustness. Process characterization is critical to the commercialization of new biopharmaceuticals since it ensures not only consistent product quality and efficacy, but also patient safety.

Successful CDMOs build client confidence by demonstrating the understanding needed to develop a robust and scalable process, backed by biostatistics and quality by design (QbD), in support of cGMP manufacturing. This article examines how Samsung Biologics combines scaled-up manufacturing data with small-scale understanding to maximize clients’ production cadence.