Next Generation Biopharmaceuticals: Product Development.

Therapeutic proteins show a rapid market growth. The relatively young biotech industry already represents 20 % of the total global pharma market. The biotech industry environment has traditionally been fast-pasted and intellectually stimulated. Nowadays the top ten best selling drugs are dominated by monoclonal antibodies (mABs).Despite mABs being the biggest medical breakthrough in the last 25 years, technical innovation does not stand still.The goal remains to preserve the benefits of a conventional mAB (serum half-life and specificity) whilst further improving efficacy and safety and to open new and better avenues for treating patients, e.g., improving the potency of molecules, target binding, tissue penetration, tailored pharmacokinetics, and reduced adverse effects or immunogenicity.The next generation of biopharmaceuticals can pose specific chemistry, manufacturing, and control (CMC) challenges. In contrast to conventional proteins, next-generation biopharmaceuticals often require lyophilization of the final drug product to ensure storage stability over shelf-life time. In addition, next-generation biopharmaceuticals require analytical methods that cover different ways of possible degradation patterns and pathways, and product development is a long way from being straight forward. The element of "prior knowledge" does not exist equally for most novel formats compared to antibodies, and thus the assessment of critical quality attributes (CQAs) and the definition of CQA assessment criteria and specifications is difficult, especially in early-stage development.