Peptide therapeutic agents are enjoying increasing success but they are challenging to produce and, not least, to purify. Purity requirements are, in fact, approaching those for small molecules. Synthesis generates a challenging crude mixture containing failed sequences and chemical variants.
The environmental impact of pharmaceutical R&D and production is considerable. Although the industry is rather conservative and also constrained by regulatory guidelines, there is increasing interest in the implementation of sustainable practices that not only improve corporate social responsibility (CSR) performance but also reduce costs and increase efficiency. This effort is embodied in the concept of Green Chemistry and includes reducing the use of toxic solvents in production and purification, which is a considerable problem. Solutions include recycling and the use of upstream protective columns that remove bioburden to increase the life-cycle of columns used downstream, or even make certain solvent-consuming steps redundant altogether.
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.