Pharmaceuticals have a prominent role in healthcare and their manufacturing requires innovative tools, scientific and engineering knowledge, and must at the same time comply with strict regulations. Efficient bioprocess development is therefore a challenging endeavor: timely monitoring and control of Critical Process Parameters (CPPs) and Critical Product Attributes (CPAs) are crucial to design, analyze, and control a bioprocess. The goal is not to have to test the quality of the product, but that it is built-in by design. Implementing Process Analytical Technology (PAT) and advanced data analytics is of paramount importance to comply with demands by regulatory bodies, while at the same time efficiently and quickly develop a robust production process.
