Why Is PAT (Process Analytical Technology) Not A Standard In Life Sciences?

By Dr. Geir Rune Flåten and co-authored by Dr. Tobias Merz, PAT Team Leader at Lonza AG

PAT (Process Analytical Technology) is a tool within the QbD (Quality by Design) toolbox enabling real-time quality assurance. However the use of PAT is still not standard within the life sciences. The reasons may be many but typical explanations are that it is too time consuming, too costly, or there is simply no proof that it will benefit the operations. The premise for any PAT implementation is that it has to benefit the operations in an efficient and economically meaningful way.