Analytical Characterization of Biotherapeutics 2017
DOI: 10.1002/9781119384434.ch1
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Introduction to Biotherapeutics

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“…The very first human biological therapeutic obtained from gene manipulation was human insulin (Humulin ® ) generated by Eli Lilly at Genentech and approved in 1982 by the US Food and Drug Administration (FDA) [5]. The application of peptides as therapeutic agents has gradually gained popularity and expanded with innovation in drug improvement and treatment archetypes [6].…”
Section: Introductionmentioning
confidence: 99%
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“…The very first human biological therapeutic obtained from gene manipulation was human insulin (Humulin ® ) generated by Eli Lilly at Genentech and approved in 1982 by the US Food and Drug Administration (FDA) [5]. The application of peptides as therapeutic agents has gradually gained popularity and expanded with innovation in drug improvement and treatment archetypes [6].…”
Section: Introductionmentioning
confidence: 99%
“…They consist of a varied group of biological substances that largely include proteins, nucleic acids, viral particles, whole cells, and vaccines [25]. Many biologics have made their way to the market; they mainly include blood factors, antibody-based drugs, anticoagulants, engineered protein scaffolds, bone morphogenetic proteins (BMPs), enzymes, Fc (crystallizable fragment of an antibody), hormones, growth factors, fusion proteins, interferons, thrombolytics, and interleukins [5]. The biological therapeutics’ production and development encounter various challenges that are quite different from those faced by classical small-molecule drugs [26].…”
Section: Introductionmentioning
confidence: 99%