Biochemical processes producing value-added-products are and will remain critical to Europe’s competitiveness and, more importantly, essential to addressing important societal challenges, such as health and food. However, bioprocess development is often excessively long with a very high failure rate. Furthermore bioprocesses of industrial biotechnology producing chemical building blocks as well as technologies for the production of biosimilars also i) receive increased attention of the regulatory framework and ii) urge for more effectiveness in the process and product lifecycle, aiming at reducing cost of goods and optimizing productivity. In order to accelerate process development, to ensure scalability as well as transferability of processes between sites or process platforms, process understanding and knowledge gathered from other products, sites and processes must be readily utilised.
Concept of Quality by Design (QbD) has been introduced over 10 years ago in the (bio)pharmaceutical industries. QbD allows manufacturers to introduce process improvements without regulatory oversight, subject to proof process understanding. However, the full benefits of QbD are not exploited for many reasons: Most of the reasons fundamentally include gathering and transferring knowledge.