LEADER 04142nam 22005775 450 001 9910731488803321 005 20230615105203.0 010 $a3-031-31909-5 024 7 $a10.1007/978-3-031-31909-9 035 $a(MiAaPQ)EBC30601968 035 $a(Au-PeEL)EBL30601968 035 $a(DE-He213)978-3-031-31909-9 035 $a(PPN)272272795 035 $a(EXLCZ)9927060219600041 100 $a20230615d2023 u| 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 14$aThe Challenge of CMC Regulatory Compliance for Biopharmaceuticals$b[electronic resource] /$fby John Geigert 205 $a4th ed. 2023. 210 1$aCham :$cSpringer Nature Switzerland :$cImprint: Springer,$d2023. 215 $a1 online resource (597 pages) 311 08$aPrint version: Geigert, John The Challenge of CMC Regulatory Compliance for Biopharmaceuticals Cham : Springer,c2023 9783031319082 320 $aIncludes bibliographical references and index. 327 $aBiopharmaceutical Landscape -- Regulatory Pathways Impacting Biopharmaceuticals -- Differences in CMC Regulatory Compliance: Biopharmaceuticals Versus Chemical Drugs -- Risk Management of the Minimum CMC Regulatory Compliance Continuum -- Ever-Present Threat of Adventitious Agent Contamination -- Starting Materials for Manufacturing the Biopharmaceutical Drug Substance -- Upstream Production of the Biopharmaceutical Drug Substance -- Downstream Purification of the Biopharmaceutical Drug Substance -- Manufacturing the Biopharmaceutical Drug Product -- Complex Process-Related Impurity Profiles -- Seemingly Endless Biomolecular Structural Variants -- Indispensable Potency (Biological Activity) -- Biopharmaceutical Critical Quality Attributes -- The Art of Setting Biopharmaceutical Specifications ? Release and Shelf-Life -- The Challenge of Demonstrating Biopharmaceutical Product Comparability -- Strategic CMC-Focused Interactions with Regulatory Authorities. 330 $aEach year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion proteins, and Fab fragments are now in the marketplace in both the United States of America (USA) and European Union (EU). There are also now over 60 biosimilars available for all major classes of recombinant proteins and monoclonal antibodies. In addition, gene therapies using genetically engineered viruses and genetically engineered cells are now in the marketplace, and continually growing. This degree of change is reflected in the over 400 CMC regulatory compliance references listed in this book that were either issued or updated since the release of the third edition. Deficiencies in biopharmaceutical CMC regulatory compliance rarely result in termination of a product, but in can readily cause months if not years of delay in initiating clinical trials, or advancing clinical development stages, or even market approval. In summary, this book: Updates real-world CMC deficiency examples with current examples; Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance; Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals. 606 $aBiologicals 606 $aBiopharmaceutics 606 $aPharmaceutical chemistry 606 $aPharmacy 606 $aBiologics 606 $aPharmaceutics 606 $aPharmacy 615 0$aBiologicals. 615 0$aBiopharmaceutics. 615 0$aPharmaceutical chemistry. 615 0$aPharmacy. 615 14$aBiologics. 615 24$aPharmaceutics. 615 24$aPharmacy. 676 $a615/.19 700 $aGeigert$b John$091349 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910731488803321 996 $aThe Challenge of CMC Regulatory Compliance for Biopharmaceuticals$92079129 997 $aUNINA