IInnovative Analytical Methodologies for Biopharmaceuticals

Biopharmaeuticals (therapeutic proteins) have recently become the fastest growing class of new drugs entering the pharmaceutical market. An example of a biopharmaceutical product is insulin which, in its recombinant form, has been launched already in the 1980s. An increasing proportion of modern biopharmaceuticals are monoclonal antibodies but cytokines, such as various interferons are also meeting urgent medical needs, for example, in multiple sclerosis. The production and pharmacological characterization of biopharmaceuticals is fundamentally different to small organic molecule drugs. The same is true for the analytical techniques that are required to measure biopharmaceuticals at all stages of drug discovery and development. The present project has the ambition to develop analytical methodologies that can be used, with a clear rationale, throughout the entire drug development process, ranging from discovery to preclinical and clinical phases including product characterization and formulation. A common theme of all methodologies is the use of affinity interactions in the design of highly selective analytical techniques in order to accurately determine biopharmaceuticals and their degradation/biotransformation products in diverse sample matrices. The consortium of three bioanalytical research groups that participate in this project has the necessary expertise and experience in the field of bioanalysis. Cross-validation of the affinity-based techniques developed in this project will ensure that the industrial partners will get access to key information regarding the most appropriate technique to be used for the analysis of individual biopharmaceuticals at each stage of drug discovery and development. Pharmaceutical and biotechnology companies as well as contract research organizations (CROs) are the main end users of the analytical technologies developed throughout this project. Furthermore, instrument companies have shown strong interest, since the implementation of novel methodologies developed in this project will enhance the applicability of dedicated instrument configurations in the various phases of drug discovery and development. Combined, these different types of intermediate and end users support this project with significant contributions both in cash and in kind (in form of free-of-charge consumables and instrumentation). Access to novel, validated analytical technologies in the field of biopharmaceuticals will lead to substantial cost reduction and faster time-to-market scenarios for both instrument and pharma/biotech companies.