LEADER 00926nam a22002531i 4500 001 991003535459707536 005 20040504123740.0 008 040802s1893 fr a||||||||||||||||fre 035 $ab13088816-39ule_inst 035 $aARCHE-104142$9ExL 040 $aBiblioteca Interfacoltà$bita$cA.t.i. Arché s.c.r.l. Pandora Sicilia s.r.l. 082 04$a840 100 1 $aLintilhac, Eugène$0178613 245 10$aLesage /$cpar Eugène Lintilhac 260 $aParis :$bLibrairie Hachette,$c1893 300 $a205 p. :$bill. ;$c19 cm 440 4$aLes grands écrivains français ;$v23 600 14$aLesage, Alain René 907 $a.b13088816$b02-04-14$c05-08-04 912 $a991003535459707536 945 $aLE002 Fondo Giudici H 1269$g1$i2002000323972$lle002$nC. 1$o-$pE0.00$q-$rn$so $t0$u0$v0$w0$x0$y.i13721082$z05-08-04 996 $aLesage$9290194 997 $aUNISALENTO 998 $ale002$b05-08-04$cm$da $e-$ffre$gfr $h0$i1 LEADER 03550nam 22004695 450 001 9910337940703321 005 20200629134022.0 010 $a3-030-13754-6 024 7 $a10.1007/978-3-030-13754-0 035 $a(CKB)4100000008153975 035 $a(MiAaPQ)EBC5771568 035 $a(DE-He213)978-3-030-13754-0 035 $a(PPN)236525336 035 $a(EXLCZ)994100000008153975 100 $a20190508d2019 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 /$fby John Geigert 205 $a3rd ed. 2019. 210 1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2019. 215 $a1 online resource (338 pages) 311 $a3-030-13753-8 327 $aComplexity of Biologics CMC Regulation -- Biopharmaceutics are Not Chemical Drugs -- An Effective CMC Strategy is Possible -- Challenge of Adventitious Agent Control -- Biopharmaceutical Source Materials -- Manufacturing of Biopharmaceutical APIs -- Manufacturing of the Drug Product -- Complex Process-Related Impurity Profiles -- Product Characterization is a Journey -- Priceless Potency (Therapeutic Activity) -- Quality Attributes of a Biopharmaceutical -- Designing the Stability Program -- The Art of Setting Specifications -- Demonstrating Product Comparability After Process Changes -- Invaluable CMC-Focused Meetings with Regulatory Authorities. 330 $aThis book since first published in 2004 has been a major resource providing insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals. 606 $aPharmacology 606 $aPharmacy 606 $aPharmacology/Toxicology$3https://scigraph.springernature.com/ontologies/product-market-codes/B21007 606 $aDrug Safety and Pharmacovigilance$3https://scigraph.springernature.com/ontologies/product-market-codes/H69010 615 0$aPharmacology. 615 0$aPharmacy. 615 14$aPharmacology/Toxicology. 615 24$aDrug Safety and Pharmacovigilance. 676 $a615.7 676 $a615.19 700 $aGeigert$b John$4aut$4http://id.loc.gov/vocabulary/relators/aut$091349 906 $aBOOK 912 $a9910337940703321 996 $aThe Challenge of CMC Regulatory Compliance for Biopharmaceuticals$92079129 997 $aUNINA