LEADER 04920nam 2200673 a 450 001 9910437842603321 005 20200520144314.0 010 $a1-299-40831-1 010 $a1-4614-4316-4 024 7 $a10.1007/978-1-4614-4316-2 035 $a(CKB)2670000000336354 035 $a(EBL)1081842 035 $a(OCoLC)828794658 035 $a(SSID)ssj0000878552 035 $a(PQKBManifestationID)11545939 035 $a(PQKBTitleCode)TC0000878552 035 $a(PQKBWorkID)10832360 035 $a(PQKB)11696145 035 $a(DE-He213)978-1-4614-4316-2 035 $a(MiAaPQ)EBC1081842 035 $a(PPN)168299879 035 $a(EXLCZ)992670000000336354 100 $a20130313d2013 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aBiophysics for therapeutic protein development /$fLinda O. Narhi, editor 205 $a1st ed. 2013. 210 $aNew York $cSpringer$d2013 215 $a1 online resource (297 p.) 225 0$aBiophysics for the life sciences 300 $aDescription based upon print version of record. 311 $a1-4899-9246-4 311 $a1-4614-4315-6 320 $aIncludes bibliographical references and index. 327 $aIntroduction -- High Throughput Biophysical Approaches to Therapeutic Protein Development -- Techniques for Higher Order Structure Determination -- Biophysical Techniques for Protein Size Distribution Analysis -- Qualification of biophysical methods for the analysis of protein therapeutics -- Application of Biophysics to the Early Developability Assessment of Therapeutic Candidates and its Application to Enhance Developability Properties -- Application of Biophysics in Formulation, Process and Product Characterization: Selected Case Studies -- Biophysical Analysis in Support of Development of Protein Pharmaceuticals -- Case Studies Applying Biophysical Techniques to Better Characterize Protein Aggregates and Particulates of Varying Size -- Investigation of Non Conformance During Protein Therapeutic Manufacturing -- Higher order structure and protein aggregate characterization of protein therapeutics: perspectives from good manufacturing practices and regulatory guidance -- Index. 330 $aThe last few decades have seen the genesis of protein therapeutics, such that these large molecule based drugs comprise an increasingly larger part of the commercial market. The conformation (overall global fold or three-dimensional structure) of these molecules is important for maintaining biological activity, stability during long term storage, and can impact the safety profile and biological consequences of administration. For this reason at every stage of product discovery and development biophysical methods play a key analytical role in product development, as they are applied for the determination of protein higher order structure. In addition to helping define binding kinetics and other parameters important for target validation, they are the only techniques available to determine if a potential protein product is folded properly, and can maintain this active conformation during manufacturing, storage, and delivery. Thus the biophysical techniques play a key role during the development of protein therapeutics. This volume is organized to mimic the product lifecycle. The initial chapters describe the underlying theory, and strengths and weaknesses of the different techniques commonly used during therapeutic development. The majority of the chapters discuss the applications of these techniques, including case studies, across the product lifecycle from early discovery, where the focus is on identifying targets, and screening for potential drug product candidates, through expression and purification, large scale production, formulation development, lot-to-lot comparability studies, and commercial support including investigations. There is also a chapter from the perspective of the regulatory agencies. This book can be used to provide insight into this important application of biophysics for those who are planning a career in protein therapeutic development, and for those outside this area who are interested in understanding it better. y>. 410 0$aBiophysics for the Life Sciences ;$v4 606 $aProteins$xBiotechnology 606 $aCell culture 606 $aProteins$xSynthesis 606 $aProteins$xTherapeutic use 606 $aBiophysics 615 0$aProteins$xBiotechnology. 615 0$aCell culture. 615 0$aProteins$xSynthesis. 615 0$aProteins$xTherapeutic use. 615 0$aBiophysics. 676 $a615.58 701 $aNarhi$b Linda O$01759385 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910437842603321 996 $aBiophysics for therapeutic protein development$94197825 997 $aUNINA