Using Lifecycle and Quality by Design (QbD) Approaches to Define, Plan, and Execute Biopharmaceutical Projects

by Mark F. Witcher, PhD
Volume 15, Issue 1 (Spring 2016)

The world in general, and biopharmaceuticals in particular, are becoming increasingly complex and challenging. The ability to plan and execute a project to efficiently and effectively achieve a high-quality project goal is especially important for developing and manufacturing biopharmaceutical products. Managing projects ranging from product development, process characterization and validation, to building new manufacturing facilities requires straightforward, effective project management approaches and tools. But perhaps even more importantly, managing a project is a fundamental enabling skill required to manage both oneself as well as teams of people. Many complex approaches and tools exist for managing projects. However, elaborate tools are rarely used, leaving many projects managed by loose, unstructured, firefighting methods. In other cases, complex tools add unnecessary time-consuming overhead and confusion. Simple, easy to understand and use methods provide a structured approach to efficiently reach the desired deliverables and goals. This paper is intended to aid in realizing complex biopharmaceutical challenges by providing a straightforward approach using QbD feedback loops within a structured project lifecycle. This article also provides an excellent example of how a well thought-out lifecycle approach can be used to understand and solve complex problems. We begin by looking at the three elements of a project...

Witcher MF. Using lifecycle and quality by design (QbD) approaches to define, plan, and execute biopharmaceutical projects. BioProcess J, 2016; 15(1): 10–7.

Posted online April 7, 2016.