Globally, there has been a significant investment in biopharmaceuticals over the last 15 years, heralding a revolution in our ability to cure disease. But discovering cures is not enough if the new medicines cannot be made in sufficient quantities to be generally available.

An increasing proportion of our medicines are predicted to be derived from the vast resources available to us through nature's biological systems. Our pharmaceutical industry is moving from a traditional focus on small molecule drugs to a new generation of superior but more complex medicines based on proteins, nucleic acids, viruses, cells and cell products. The therapeutic opportunities are huge. However, biotherapeutic drugs cannot be manufactured using the tried-and-tested methods of chemical synthesis that were so effective for small molecule drugs. Instead we must work with nature to learn how to harness the power of biological systems.

A greater understanding of bioprocesses must be developed to enable us to reproducibly make complex biological molecules both at high quality and at large scale. We must have a new emphasis on scientific understanding which embraces an intrinsic link between product quality and the manufacturing process. Biopharmaceutical Process Development is the mechanism by which we develop high productivity manufacturing processes that deliver cost-effective, consistent and safe biotherapeutic drugs. Our toolkit includes cutting edge tools and techniques of Process Analytical Technology (PAT) and Quality by Design (QbD).

'It is critical that we find better, faster ways of developing bioprocesses designed to manufacture product more consistently'

The QbD approach for biopharmaceutical process development will reduce the regulatory burden by understanding and controlling sources of variability throughout the drug development lifecycle - from discovery and development to product manufacture.

'Quality cannot be tested into product. Quality should be built in by design'

Quality will be in-built and intrinsic to the entire manufacturing system, rather than a parameter tested only in the final product.

The Biopharmaceutical Bioprocessing Technology Centre has developed the InsideBiosystems advanced training concept for the implementation of QbD. InsideBiosystems has been designed to meet the growing need for practical training to equip scientists with the skills to apply QbD. Founded on an established critical mass of targeted QbD research and teaching, InsideBiosystems ensures both skills development and the ability to troubleshoot and solve development challenges.

We welcome enquiries about our research activities and training courses.

+ 01.02.Bioprocessing