When it comes to many serious and challenging diseases, healthcare has reached a point of unsustainability, due to drug costs. For example, sustained therapy for an autoimmune disease or cancer, involving large amounts of monoclonal antibodies (mAbs), might not be a viable option for simple economic reasons. As a consequence, healthcare authorities want to reduce the cost of drugs by encouraging the development of biosimilars. When biological drugs are off-patent they can be copied – which is cheaper than developing the novel drug, but still challenging because of the need to demonstrate the same efficacy and safety. Drug purification, a key to successful manufacture of biologicals, must also adapt by exploiting products and technologies that lower the overall cost of production.
As our understanding of diseases at the molecular level increases, so does the potential for monoclonal antibody (mAb) - related therapies. Platform approaches to mAb production, including purification, are a key to their successful manufacture and, in particular, streamline process development.
The healthcare sector and developers of new pharmaceuticals are facing increasing challenges, along with pressure to lower costs. At the same time pharmaceutical development is undergoing a revolution with the use of biological substances as therapeutics.
We took a general look at some aspects of the biopharmaceutical industry today, the particular cost challenges facing chromatographic purification of biomolecules and some means of increasing chromatography efficiency that are close to hand.