Pharmaceutical Biotechnology: Concepts and Applications

Pharmaceutical Biotechnology offers students taking Pharmacy and related Medical and Pharmaceutical courses a comprehensive introduction to the fast-moving area of biopharmaceuticals. With a particular focus on the subject taken from a pharmaceutical perspective, the book offers a broad introduction to protein science and recombinant DNA technology, key areas that underpin the whole subject. With two separate chapters devoted to these important topics, students are provided with the basic principles and coverage of how these techniques are applied in the development and production of biopharmaceuticals.Table of Contents:PrefaceAcronymsPharmaceuticals, biologics and biopharmaceuticalsIntroduction to pharmaceutical productsBiopharmaceuticals and pharmaceutical biotechnologyHistory of the pharmaceutical industryThe age of biopharmaceuticalsBiopharmaceuticals: Current status and future prospectsProtein structureIntroductionOverview of protein structureHigher level structureProtein stability and foldingProtein post-translational modificationGene manipulation and recombinant DNA technologyIntroductionNucleic acids: Function and structureRecombinant production of therapeutic proteinsClassical gene cloning and identificationThe drug development processIntroductionDiscovery of biopharmaceuticalsThe impact of genomics and related technologies upon drug discoveryGene chipsProteomicsStructural genomicsPharmacogeneticsInitial product characterizationPatentingDelivery of biopharmaceuticalsNasal, trans mucosal and transdermal delivery systemsPreclinical studiesPharmacokinetics and pharmacodynamicsToxicity studiesThe role and remit of regulatory authoritiesConclusionSources and upstream processingIntroductionSources of biopharmaceuticalsUpstream processingDownstream processingIntroductionInitial product recoveryCell disruptionRemoval of nucleic acidInitial product concentrationChromatographic purificationHigh-performance liquid chromatography of proteinsPurification of recombinant proteinsFinal product formulationProduct analysisIntroductionProtein-based contaminantsRemoval of altered forms of the protein of interest from the product streamDetection of protein-based product impuritiesImmunological approaches to detection of contaminantsEndotoxin and other pyrogenic contaminantsThe cytokines: The interferon familyCytokinesCytokine receptorsCytokines as biopharmaceuticalsThe interferonsInterferon biotechnologyConclusionCytokines: Interleukins and tumour necrosis factorIntroductionInterleukin-2Interleukin-1Interleukin-11Tumour necrosis factorsGrowth factorsIntroductionHematopoietic growth factorsGrowth factors and wound healingTherapeutic hormonesIntroductionInsulinGlucagonHuman growth hormoneThe gonadotropinsMedical and veterinary applications of gonadotropins