By Sarah Mercier and Herman van Herk, Vaccine Process and Analytical Development, Janssen
Knowledge management has improved through deploying elements of Lean thinking in the cell culture process development department of a vaccine producing company. Lean (or lean thinking) is a philosophy derived from Toyota, where focus is on eliminating waste from the processes and thus creating more value for the customers with fewer resources.
Sets of tools and methods have been developed from Lean aimed at eliminating waste, such as 5S, value stream mapping, Kaizen/continuous improvement, Poka Yoke, visual control, etc. Beyond using these tools and methods, Lean can also be defined as a culture mindset focusing on philosophy, processes, people and problem solving. The biopharmaceutical industry is a field where more and more examples of implementation of Lean have been published, both in manufacturing and more recently in development environments.
Biopharmaceutical products can be very complex molecules manufactured using elaborate multi-step processes after 10 to 15 years of development, requiring intense knowledge input throughout these long product life cycles. Moreover, biopharmaceutical companies are continuously striving to improve their productivity and efficiency, and regulatory agencies have raised their expectations, for the implementation of Quality by Design (QbD) and life cycle Process Validation, both of which are modern approaches to the demonstration of control of consistent good quality of the product manufactured. As a result, initiatives are stimulated in this industry towards the development and improvement of knowledge management systems. The aim of knowledge management is to transform data into information and then into knowledge by the means of systematic management and organisational approaches.
In our presentation at BioProcess International Europe, the different elements of Lean that have been implemented are exposed as well as the wastes they contributed to eliminating and the gains in productivity and efficiency attained. The link between Lean and KM and the way these Lean elements have improved the existing KM systems are then exposed. Finally, the way this initiative in turn benefits the application of QbD and the entry into late stage process development which the organization is currently facing is also discussed. Overall the presentation demonstrates how Lean, knowledge management and QbD have been implemented in an industrial setting and how they link with each other to improve process operation, scientific development and ultimately product quality, which are all key elements for high quality vaccine development with short time-to-market.