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Pharmaceutical biotechnology has a long tradition and is rooted in the last century, first exemplified by penicillin and streptomycin as low molecular weight biosynthetic compounds. Today, pharmaceutical biotechnology still has its fundamentals in fermentation and bioprocessing, but the paradigmatic change affected by biotechnology and pharmaceutical sciences has led to an updated definition. Upon a suggestion by the European Association of Pharma Biotechnology (EAPB), pharmaceutical biotechnology is defined as a science covering all technologies required for the production, manufacturing, and registration of biotechnological drugs. The biopharmaceutical industry has changed dramatically since the first recombinant protein (Humulin) was approved for marketing in 1982. The range of resources required for the pharmaceutical industry has expanded from its traditional fields. Advances in the field of recombinant genetics allows scientists to routinely clone genes and create genetically modified organisms that can be used in industrial production processes. Also, specific therapeutic proteins can be synthesized in no biological ways.
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