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Informationen zum Autor Sarfaraz K. Niazi! PhD! is the founding executive chairman of Therapeutic Proteins International LLC! a world-class pure-play developer and manufacturer of biosimilar and interchangeable recombinant biologics! headquartered in Chicago. Dr. Niazi began his career teaching pharmacy at the University of Illinois (1972-1988)! where he became a tenured professor. He then entered the pharmaceutical industry at Abbott International! becoming a Volwiler Fellow. He left Abbott in 1995 with a passion for making high-cost biological drugs affordable. Dr. Niazi set up several ex-U.S. biosimilar companies and! in 2003! established Therapeutic Proteins International! the only U.S. integrated company of its kind to date. Zusammenfassung What's the Deal with Biosimilars?Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set that covers varying aspects of biosimilars! Biosimilars and Interchangeable Biologics: Tactical Elements explores the development and manufacturing of biosimilars and targets challenges surrounding the creation of these products. This includes manufacturing! production costs! and intellectual property barriers! particularly in regulated markets (regulatory agencies are still in the process of developing guidelines). It addresses the complexity of biological drugs! and it discusses specific structural elements vital to the functionality! immunogenicity! and safety of biosimilar products.Of specific interest to practitioners! researchers! and scientists in the biopharmaceutical industry! this volume provides an overall understanding of the hurdles! difficulties! and practicalities of developing a strong plan. It introduces a step-by-step approach for creating a strategy that helps develop and manufacture a biosimilar product while reducing overall production costs and meeting the requirements of biosimilarity based on analytical and functional! pharmacokinetic! pharmacodynamic (where applicable)! and nonclinical toxicology or toxicokinetic similarity (where appropriate) while remaining competitive in the market. ?? Inhaltsverzeichnis Structural and Functional ElementsBasicsMultidimensional ViewPrimary StructureSecondary StructureTertiary StructureQuaternary StructurePosttranslational Modification (PTM)Protein FoldingProtein Structural VariabilityRecombinant DNABibliographyImmunogenicity ConsiderationsIntroductionImmune SystemAntigensAntibodyProtein ImmunogenicityBiosimilar Product ImmunogenicityImmunogenicity TestingConclusionBibliographyProduct Development StrategiesBackgroundSelection of ProductManufacturing System SelectionCell Line ChoiceReference ProductTest Method DevelopmentSpecificationsReverse EngineeringAnalytical and Functional SimilarityNonclinical StudiesClinical Pharmacology StudiesInterchangeability ProtocolsRegulatory UncertaintyLegal Teams in PlaceCommercialization ChallengesBibliographyStability and Formulation ConsiderationsIntroductionFormulation of Biosimilar ProductsCommon Formulation ElementsHigh Concentration FormulationsStability Testing GuidanceBibliographyBiosimilarity TetrahedronTetrahedron ConceptSimilarity ConceptComparability versus SimilarityAnalytical and Functional SimilarityAnalytical InstrumentationIdentityPurityPotencySafetyClinical DataRisk-Based Critical Quality AttributesNonclinical DataStages of Analytical SimilarityLevel of SimilarityStatistical Modeling of Similarity DataInterchangeabilityConclusionBibliographyRecombinant Expression SystemsBackgroundExpression System DevelopmentManipulations to Improve YieldMammalian Cells Expression SystemsMammalian Cell Expression ImprovementsYeast Expression SystemsInsect CellsTransgenic AnimalsCell BanksBibli...
