Protein Quality Testing in the Era of Personalized Medicine

Abstract

The current pharmaceutical system is not sustainable; new drugs have limited impact on public health, they are (too) expensive and innovation has stalled because of overregulation of the industry. We suggest reviving compounding by pharmacists as the pharmaceutical model for the future allowing for innovation. Bedside production of biologics by magistral compounding under direct control by a pharmacist is considered key to the introduction of personalized medicines. Although specific regulations are lacking, appropriate quality testing will be essential for magistral preparations to be accepted by patients and doctors. In classical drug development a myriad of different, often redundant, techniques are being used for protein characterization. In most cases, the specification of these test are set based on history, the cut-off of the test, specifications of comparable products rather than on clinically set limits. Here, we propose a quality testing approach for two hypothetical biopharmaceuticals, a monoclonal antibody and an enzyme replacement therapy, based on common sense and a risk analysis.

Keywords: Antibody drug(s); Biotechnology; Formulation; Protein(s); Regulatory science.