New drugs based on recombinant DNA technology
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Over the last 20 years, some 100 biopharmaceuticals have gained marketing authorization in Europe, USA and other world regions. All biopharmaceutical products currently approved within the EU are protein-based. The majority of the first generation products were either unmodified monoclonal antibodies or proteins used clinically to either replace or augment levels of native human proteins. With the recent advances in genomics, proteomics, pharmaceutical target validation, and lead compound identification new perspectives of biopharmaceutical products development emerged. Protein engineering has recently facilitated the rational development of a number of proteins displaying an altered pharmacokinetics, biodistribution and therapeutic properties. New strategies and challenges in biopharmaceuticals developments yielded the second generation of protein drugs.
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K. Kiec-Kononowicz, Zaklad Technologii Chemicznej Srodkow Leczniczych Collegium Medicum, Uniwersytet Jagiellonski, ul. Medyczna 9, 30-688 Krakow, Poland