The list of biopharmaceuticals produced by recombinant DNA technology, transgenics and synthetic manufacture continues to grow to encompass therapeutic and diagnostic agents ranging from antibodies to vaccines. In addition, second generation, Biosimilar and BioBetter products are also now available. Biological products are currently outgrowing small molecule drugs in the market and it is predicted that by 2016, 7 out of the top 8 pharma sellers will be biologics. Regardless of the method of production, all these products present the biotechnology community with complex challenges in manufacture and ultimately analytical characterisation. Recognizing the importance of these products, and the issues involved with potential post-translational and chemical modifications of the protein structure, regulatory agencies throughout the world are concerned with the “safety, purity, potency and strength” of biotherapeutics.