{"product_id":"characterizing-biotherapeutics-isbn-9781394236114","title":"Characterizing Biotherapeutics","description":"\u003cp\u003e\u003cb\u003eProvides detailed and up-to-date coverage of analytical approaches for biologic drug modalities\u003c\/b\u003e \u003c\/p\u003e\u003cp\u003eThe development of innovative biologic therapies has revolutionized medicine, but their complexity demands equally advanced analytical approaches. \u003ci\u003eCharacterizing Biotherapeutics: Analytical Methods for Diverse Modalities \u003c\/i\u003e introduces the tools and techniques used to analyze these groundbreaking therapies. Designed to help readers characterize and troubleshoot increasingly diverse and sophisticated therapeutic molecules, this in-depth guide addresses different biologic drugs, their unique analytical challenges, and the methods that enable their analysis. \u003c\/p\u003e\u003cp\u003eOrganized into two comprehensive sections, \u003ci\u003eCharacterizing Biotherapeutics\u003c\/i\u003e first delves into the fundamentals of analytical platforms, providing a robust foundation in techniques such as mass spectrometry and biophysical assays. The second section applies these methods to real-world scenarios, focusing on drug discovery, clinical evaluation, and commercial considerations in drug development. Authors Jennie R. Lill and Wendy Sandoval provide clear guidance tailored to the evolving demands of therapeutic innovations such as structural characterization, high-throughput biophysical assays, and RNA-based therapeutics. \u003c\/p\u003e\u003cp\u003eEquipping researchers with the knowledge to navigate the challenges posed by increasingly complex biologics, \u003ci\u003eCharacterizing Biotherapeutics: Analytical Methods for Diverse Modalities:\u003c\/i\u003e \u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eDiscusses new and emerging biological molecule diversity and both traditional analytical methods\u003c\/li\u003e \u003cli\u003eProvides characterization strategies for large molecule (protein\/antibody) based therapeutics\u003c\/li\u003e \u003cli\u003eSummarizes cutting-edge technologies for novel modalities and antibody protein therapeutics\u003c\/li\u003e \u003cli\u003eIncorporates the latest advancements in mass spectrometry, functional assays, and biophysical methods\u003c\/li\u003e \u003cli\u003eAddresses specialized analytical issues for membrane proteins and other challenging targets\u003c\/li\u003e \u003cli\u003ePresents methodologies for assessing safety and therapeutic potential\u003c\/li\u003e\n\u003c\/ul\u003e \u003cp\u003e\u003ci\u003eCharacterizing Biotherapeutics: Analytical Methods for Diverse Modalities\u003c\/i\u003e is an essential reference for analytical scientists, biologists, and mass spectrometrists involved in biomolecule analysis. It is also a valuable resource for graduate students taking advanced courses in biotechnology, drug development, and biotherapeutic analysis, as well as professionals in biotechnology and pharmaceutical industries working to advance biotherapeutic research and development. \u003c\/p\u003e\u003cp\u003eAbout the Editors xvii\u003c\/p\u003e \u003cp\u003eList of Contributors xix\u003c\/p\u003e \u003cp\u003ePreface xxv\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Introduction 1\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eAlissa D. Guarnaccia, Wendy Sandoval, and Jennie R. Lill\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eExploring a Diversity of Biotherapeutic Approaches 1\u003c\/p\u003e \u003cp\u003eDelivering Diverse Biotherapeutics to Expand Patient Treatment 2\u003c\/p\u003e \u003cp\u003eUnlocking Innovation: The Role of Biophysical Techniques in Drug Discovery and Development 2\u003c\/p\u003e \u003cp\u003eIncreasing Throughput: The Role of High-Quality Analytical Assays in Characterizing Biotherapeutics 3\u003c\/p\u003e \u003cp\u003eThe Next Frontier: Additional Bioanalytical Tools and Targets on the Horizon 3\u003c\/p\u003e \u003cp\u003eArtificial Intelligence and Machine Learning: A Transformative Shift for Computational Tools 4\u003c\/p\u003e \u003cp\u003eA Bioanalytical Call to Action! 4\u003c\/p\u003e \u003cp\u003eReferences 5\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Analytical Characterization of Bispecific Antibodies and Bispecific Molecules 7\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eMichael Dillon, T. Noelle Lombana, and Christoph Spiess\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIntroduction 7\u003c\/p\u003e \u003cp\u003eBispecific Antibodies and Alternative Scaffolds with Tethered Domains 9\u003c\/p\u003e \u003cp\u003eIdentifying the Best Parental Antibody Pairs to Combine in a BsAb 13\u003c\/p\u003e \u003cp\u003eAlternatives to Bispecific Antibodies: Antibody Mixtures 14\u003c\/p\u003e \u003cp\u003eCharacterization of the Bispecific Molecule 14\u003c\/p\u003e \u003cp\u003eCharacterization by Mass Spectrometry Methods 15\u003c\/p\u003e \u003cp\u003eConclusions 20\u003c\/p\u003e \u003cp\u003eAbbreviations 20\u003c\/p\u003e \u003cp\u003eReferences 21\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Analytical Challenges in Analyzing IgM Biotherapeutics 29\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eAmber D. Rolland and Albert J.R. Heck\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIntroduction 29\u003c\/p\u003e \u003cp\u003eCharacterization of Biotherapeutic mAbs 31\u003c\/p\u003e \u003cp\u003eIgM Sequence and Structure 31\u003c\/p\u003e \u003cp\u003eIgM Assembly Factors 35\u003c\/p\u003e \u003cp\u003eIgM Glycosylation Patterns 38\u003c\/p\u003e \u003cp\u003eIgM Disulfide Bond Networks 44\u003c\/p\u003e \u003cp\u003eConclusions 47\u003c\/p\u003e \u003cp\u003eAcknowledgments 48\u003c\/p\u003e \u003cp\u003eReferences 48\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Mass Spectrometric Characterization of Therapeutic Recombinant Proteins 55\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eAlissa D. Guarnaccia, Corey E. Bakalarski, Wendy Sandoval, and Jennie R. Lill\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIntroduction 55\u003c\/p\u003e \u003cp\u003eInstrumentation 55\u003c\/p\u003e \u003cp\u003eSoftware for the Analysis of Intact Molecular Weight Measurements 60\u003c\/p\u003e \u003cp\u003eEmerging Mass Spectrometric Approaches for Characterizing Molecular Heterogeneity in Biotherapeutics 61\u003c\/p\u003e \u003cp\u003eTandem Mass Spectrometric Characterization of Biomolecules 61\u003c\/p\u003e \u003cp\u003eData Acquisition Methods 63\u003c\/p\u003e \u003cp\u003eQuantitative Mass Spectrometric Methods 63\u003c\/p\u003e \u003cp\u003eComputational Analysis of Tandem Mass Spectra 64\u003c\/p\u003e \u003cp\u003eConclusions and Perspectives 65\u003c\/p\u003e \u003cp\u003eAbbreviations 65\u003c\/p\u003e \u003cp\u003eReferences 66\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Therapeutic Proteins and Hyphenated Methods for Characterization 71\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eDietmar Reusch and Markus Haberger\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIntroduction 71\u003c\/p\u003e \u003cp\u003eMethods 71\u003c\/p\u003e \u003cp\u003eConsiderations 81\u003c\/p\u003e \u003cp\u003eQuality Control Feasibility 81\u003c\/p\u003e \u003cp\u003eConclusions 82\u003c\/p\u003e \u003cp\u003eReferences 82\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Methods for Characterization and Optimization of Peptide Therapeutics: Bioanalysis and Biotransformation 85\u003cbr\u003e \u003c\/b\u003e\u003ci\u003ePhillip Chu, Suk-Joon Hyung, Robert S. Jones, S. Cyrus Khojasteh, Dennis H. Leung, Bin Ma, Huy Nguyen, Emile Plise, Ola M. Saad, John C. Tran, Qinying Yu, and Xing Zhang\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIntroduction 85\u003c\/p\u003e \u003cp\u003eAcknowledgment 104\u003c\/p\u003e \u003cp\u003eReferences 104\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Structural Characterization of Biotherapeutics and New Modalities 109\u003cbr\u003e \u003c\/b\u003e\u003ci\u003ePaola Di Lello and Patrick Lupardus\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIntroduction 109\u003c\/p\u003e \u003cp\u003eAntigens, Epitopes, and Paratopes 109\u003c\/p\u003e \u003cp\u003eRecombinant Antigen Generation 116\u003cbr\u003e N-Linked Glycosylation 117\u003c\/p\u003e \u003cp\u003eManipulating N-Linked Glycans on Antigens 118\u003c\/p\u003e \u003cp\u003eAntibody Generation for Crystallography 119\u003c\/p\u003e \u003cp\u003eCrystallization of Antibody\/Antigen Complexes 119\u003c\/p\u003e \u003cp\u003eConsideration for New Modalities and New Targets 120\u003c\/p\u003e \u003cp\u003eConclusion 121\u003c\/p\u003e \u003cp\u003eAbbreviations 121\u003c\/p\u003e \u003cp\u003eReferences 122\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Modern Methods for Characterizing the Higher-Order Structure (HOS) of Biotherapeutics 129\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eFelix Kuhne, Rachel P. Liu, Lingfei Wang, Aaron T. Wecksler, Manasi Gaikwad, Christine C. Jao, Alberto Estevez, Roshan M. Regy, and Saeed Izadi\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eProtein Higher-Order Structure (HOS) 129\u003c\/p\u003e \u003cp\u003eImportance of HOS Characterization in Biotherapeutic Development 131\u003c\/p\u003e \u003cp\u003eHydrogen\/Deuterium Exchange Mass Spectrometry (H\/DX-MS) 134\u003c\/p\u003e \u003cp\u003eHydroxyl Radical Protein Footprinting Mass Spectrometry (HRPF-MS) 137\u003c\/p\u003e \u003cp\u003eCovalent Labeling Mass Spectrometry (CL-MS) 139\u003c\/p\u003e \u003cp\u003eX-Ray Crystallography 141\u003c\/p\u003e \u003cp\u003eCryogenic Electron Microscopy (Cryo-EM) 145\u003c\/p\u003e \u003cp\u003eMultiscale in-silico Modeling of Biotherapeutics 149\u003c\/p\u003e \u003cp\u003eConclusion 153\u003c\/p\u003e \u003cp\u003eReferences 153\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Target Binding Assays for Biotherapeutics 161\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eEric Janezic and Xiangdan Wang\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIntroduction 161\u003c\/p\u003e \u003cp\u003eAssays to Determine Affinity of Biotherapeutics 161\u003c\/p\u003e \u003cp\u003eCell-Based Affinity assays 166\u003c\/p\u003e \u003cp\u003eConclusions 171\u003c\/p\u003e \u003cp\u003eReferences 172\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Functional Assays for Screening Protein Biotherapeutics 175\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eMaureen Beresini and Kelly Loyet\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIntroduction 175\u003c\/p\u003e \u003cp\u003eDevelopment of a Screening Cascade 175\u003c\/p\u003e \u003cp\u003eBiochemical Assays for Cellular Receptor-Binding or Extracellular Targets 180\u003c\/p\u003e \u003cp\u003eCellular Assays for a Cell Signaling Readout 181\u003c\/p\u003e \u003cp\u003eFundamentals of Assay Development, Validation, and Implementation 187\u003c\/p\u003e \u003cp\u003eConcluding Remarks 192\u003c\/p\u003e \u003cp\u003eReferences 193\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Immunogenicity Profiling of Biotherapeutics (Wiley Book – Bioanalytical Characterization of New Therapeutic Modalities) 197\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eQui T. Phung, M. Violet Lee, Ola Saad, Sivan Cohen, Yinyin Li, Mercedesz Balasz, Jieming Chen, Zhaojun Yin, Zhenru Zhou, and Jennie R. Lill\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIntroduction 197\u003c\/p\u003e \u003cp\u003eThe Anti-drug Antibody Response 199\u003c\/p\u003e \u003cp\u003eClinical Monitoring of ADAs 200\u003c\/p\u003e \u003cp\u003eADA Assay Development Challenges and Considerations for New Modalities 201\u003c\/p\u003e \u003cp\u003eIntegrating Immunogenicity Assessments, Harmonization, and Incorporation of Clinically Relevant Information into Drug Product Labeling 201\u003c\/p\u003e \u003cp\u003eThe Clinical Impact of an ADA 201\u003c\/p\u003e \u003cp\u003eAssays Employed to Assess Immunogenicity Risk 202\u003c\/p\u003e \u003cp\u003eIn Silico Approaches for Immunogenicity Risk Assessment 202\u003c\/p\u003e \u003cp\u003eT-Cell and Other Cellular Assays 205\u003c\/p\u003e \u003cp\u003eMHC II Immunopeptidome 209\u003c\/p\u003e \u003cp\u003eData Visualization and Curation 214\u003c\/p\u003e \u003cp\u003eEngineering Best Practices Post-immunogenicity Hotspot Data Elucidation 214\u003c\/p\u003e \u003cp\u003eConclusion 215\u003c\/p\u003e \u003cp\u003eAbbreviations 215\u003c\/p\u003e \u003cp\u003eReferences 216\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 High-Throughput Biophysical Assays for Developability Assessment 223\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eEmma Pelegri-O’Day and Nithya Srinivasan\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIntroduction 223\u003c\/p\u003e \u003cp\u003eHigh-Throughput Intact Mass Spectrometry 223\u003c\/p\u003e \u003cp\u003eAggregation 225\u003c\/p\u003e \u003cp\u003eSize Variants 226\u003c\/p\u003e \u003cp\u003eHydrophobicity 227\u003c\/p\u003e \u003cp\u003eCharge Variants 227\u003c\/p\u003e \u003cp\u003eViscosity 229\u003c\/p\u003e \u003cp\u003eConformational Stability 230\u003c\/p\u003e \u003cp\u003eChemical Stability Assessment 231\u003c\/p\u003e \u003cp\u003eLeveraging AI\/ML for Molecule Assessment 233\u003c\/p\u003e \u003cp\u003eFuture of Developability Assessments 234\u003c\/p\u003e \u003cp\u003eReferences 235\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 Establishing Analytical Methods for RNA-Based Therapeutics Characterization 243\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eJulien Camperi, Emily Freund, Carolina Galan, and Axel Guilbaud\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eIntroduction to RNA-Based Therapeutics 243\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eApplications of RNA-Based Drugs 243\u003c\/p\u003e \u003cp\u003eQuality Attributes and Techniques for the Characterization of mRNA 245\u003c\/p\u003e \u003cp\u003eRNA Integrity and Purity 247\u003c\/p\u003e \u003cp\u003emRNA Quality Features 250\u003c\/p\u003e \u003cp\u003eFunctionality Testing 252\u003c\/p\u003e \u003cp\u003eConclusion 255\u003c\/p\u003e \u003cp\u003eReferences 256\u003c\/p\u003e \u003cp\u003e\u003cb\u003e14 Analytical Methods Shaping Cell Therapy Characterization 261\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eAmritha Lewis, Sadhu Sudeshna, Melmon Rebecca, Shaik Rahamthulla, Tutuncuoglu Egemen, and Gilbert Amy\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIntroduction 261\u003c\/p\u003e \u003cp\u003eFundamentals of T-Cell Immunology in Cell Therapy 262\u003c\/p\u003e \u003cp\u003eMeasuring Immune Receptor Expression 262\u003c\/p\u003e \u003cp\u003eFunctional Cell-Based Assays for In Vitro Characterization 264\u003c\/p\u003e \u003cp\u003eCell Phenotyping 265\u003c\/p\u003e \u003cp\u003eImmune Monitoring: BCR and TCR Sequencing 266\u003c\/p\u003e \u003cp\u003eConclusions 267\u003c\/p\u003e \u003cp\u003eAcknowledgment 267\u003c\/p\u003e \u003cp\u003eReferences 267\u003c\/p\u003e \u003cp\u003e\u003cb\u003e15 Characterizing Nucleic Acid-, Gene-, and Cell-Based Therapeutics with Sequencing Technologies 271\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eHayley M. Bennett, Ashley Byrne, William Stephenson, and Zora Modrusan\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIntroduction 271\u003c\/p\u003e \u003cp\u003eDNA Sequencing 271\u003c\/p\u003e \u003cp\u003eNucleic-Acid-Based Therapeutics 274\u003c\/p\u003e \u003cp\u003eGene-Based Therapies 277\u003c\/p\u003e \u003cp\u003eCell-Based Therapies 279\u003c\/p\u003e \u003cp\u003eImmune Repertoire Sequencing Facilitates Therapeutic Advances 280\u003c\/p\u003e \u003cp\u003eConclusions and Future Perspectives 282\u003c\/p\u003e \u003cp\u003eAbbreviations 282\u003c\/p\u003e \u003cp\u003eReferences 283\u003c\/p\u003e \u003cp\u003e\u003cb\u003e16 Mass Spectrometry-Based Methods to Investigate Protein–Protein Interactions in Cells and Their Application in Drug Discovery 289\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eTess Branon\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIntroduction 289\u003c\/p\u003e \u003cp\u003eAffinity Purification Mass Spectrometry (AP-MS) 290\u003c\/p\u003e \u003cp\u003eCross-Linking Mass Spectrometry (XL-MS) 293\u003c\/p\u003e \u003cp\u003eProximity Labeling Mass Spectrometry (PL-MS) 296\u003c\/p\u003e \u003cp\u003eConcluding Remarks and Other Interactomic Technologies 302\u003c\/p\u003e \u003cp\u003eAbbreviations 307\u003c\/p\u003e \u003cp\u003eReferences 308\u003c\/p\u003e \u003cp\u003e\u003cb\u003e17 Receptomics and Extracellular Interactomics for Biotherapeutic Characterization 321\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eNaincy R. Chandan, Abel Ferrel, and Shengya Cao\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIntroduction 321\u003c\/p\u003e \u003cp\u003eReceptomic and Extracellular Interactomics Technology Overview 322\u003c\/p\u003e \u003cp\u003eNatural Products and Peptides 325\u003c\/p\u003e \u003cp\u003eAntibodies and Related Proteins 326\u003c\/p\u003e \u003cp\u003eLipid Nanoparticles (LNPs), Extracellular Vesicles (EVs), Virus-Like Particles (VLPs) and Viruses 331\u003c\/p\u003e \u003cp\u003eCell Therapies 332\u003c\/p\u003e \u003cp\u003eSummary 334\u003c\/p\u003e \u003cp\u003eAbbreviations 334\u003c\/p\u003e \u003cp\u003eReferences 335\u003c\/p\u003e \u003cp\u003e\u003cb\u003e18 Membrane Proteins: Challenging Biotherapeutic Targets 341\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eHiruni S. Jayasekera, Farhana Afrin Mohona, and Michael T. Marty\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eMembrane Proteins: Challenging Biotherapeutic Targets Families of Membrane Proteins 341\u003c\/p\u003e \u003cp\u003eMembrane Protein Solubilization Methods 344\u003c\/p\u003e \u003cp\u003eMS Analysis of Membrane Proteins 349\u003c\/p\u003e \u003cp\u003eConclusion 353\u003c\/p\u003e \u003cp\u003eAcknowledgments 353\u003c\/p\u003e \u003cp\u003eReferences 353\u003c\/p\u003e \u003cp\u003e\u003cb\u003e19 Chemoproteomics Approaches for Diverse Modalities 365\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eH. Christian Eberl, Sascha Knecht, Markus A. Queisser, and Marcus Bantscheff\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIntroduction 365\u003c\/p\u003e \u003cp\u003eChemoproteomics Approaches 367\u003c\/p\u003e \u003cp\u003eProbe-Based (Direct) Target Deconvolution 367\u003c\/p\u003e \u003cp\u003eTarget Deconvolution Without Chemical Probes 369\u003c\/p\u003e \u003cp\u003eProximity-Labeling Approaches 370\u003c\/p\u003e \u003cp\u003eMechanism-Centric (Indirect) Proteomics Methods 370\u003c\/p\u003e \u003cp\u003eCovalent Drugs 370\u003c\/p\u003e \u003cp\u003eProtein Degraders 373\u003c\/p\u003e \u003cp\u003eAntibody–Drug Conjugates and Oligonucleotides 377\u003c\/p\u003e \u003cp\u003eConcluding Remarks 378\u003c\/p\u003e \u003cp\u003eAcknowledgments 379\u003c\/p\u003e \u003cp\u003eAbbreviations 379\u003c\/p\u003e \u003cp\u003eReferences 379\u003c\/p\u003e \u003cp\u003e\u003cb\u003e20 Drug-Delivery Modalities and Mechanisms 385\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eYu Tong Tam, Madyson Migliozzi, Devin B. Tesar, Amin Famili, Aaron T. Wecksler, Sara Wichner, Alavattam Sreedhara, and Whitney Shatz-Binder\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIntroduction 385\u003c\/p\u003e \u003cp\u003eDelivery of Proteins 387\u003c\/p\u003e \u003cp\u003eDelivering Genes to the Immune System: Enabling Cell-Specific Targeting 399\u003c\/p\u003e \u003cp\u003eTissue-Specific Delivery: Targeting the Brain Parenchyma 402\u003c\/p\u003e \u003cp\u003eDirect Injection 402\u003c\/p\u003e \u003cp\u003eNext-Generation Approaches with Some Clinical Data 403\u003c\/p\u003e \u003cp\u003eAn Analytical Perspective to Drug-Delivery Technology Development 409\u003c\/p\u003e \u003cp\u003eConclusions\/Future Perspectives 419\u003c\/p\u003e \u003cp\u003eAbbreviations 421\u003c\/p\u003e \u003cp\u003eReferences 422\u003c\/p\u003e \u003cp\u003eIndex 439\u003c\/p\u003e  \u003cp\u003e\u003cb\u003eJennie R. Lill, PhD,\u003c\/b\u003e is the Executive Director of the Proteomic and Genomic Technologies Department at Genentech, where she has worked since 2004. With over 90 peer-reviewed publications and three books, including \u003ci\u003eAnalytical Characterization of Biotherapeutics\u003c\/i\u003e, her work focuses on cutting-edge analytical techniques in drug discovery and development. \u003c\/p\u003e\u003cp\u003e\u003cb\u003eWendy Sandoval\u003c\/b\u003e was the Director of Translational Mass Spectrometry in Research at Genentech, where she had been a pivotal contributor for over 30 years. She has authored more than 100 scientific publications and co-authored two books, including \u003ci\u003eAnalytical Characterization of Biotherapeutics\u003c\/i\u003e. She now runs a plant nursery and botanical garden in Northern California (https:\/\/botanicanurseryandgardens.com\/) and enjoys playing in dirt.   \u003c\/p\u003e\u003cp\u003e\u003cb\u003eProvides detailed and up-to-date coverage of analytical approaches for biologic drug modalities\u003c\/b\u003e \u003c\/p\u003e\u003cp\u003eThe development of innovative biologic therapies has revolutionized medicine, but their complexity demands equally advanced analytical approaches. \u003ci\u003eCharacterizing Biotherapeutics: Analytical Methods for Diverse Modalities \u003c\/i\u003e introduces the tools and techniques used to analyze these groundbreaking therapies. Designed to help readers characterize and troubleshoot increasingly diverse and sophisticated therapeutic molecules, this in-depth guide addresses different biologic drugs, their unique analytical challenges, and the methods that enable their analysis. \u003c\/p\u003e\u003cp\u003eOrganized into two comprehensive sections, \u003ci\u003eCharacterizing Biotherapeutics\u003c\/i\u003e first delves into the fundamentals of analytical platforms, providing a robust foundation in techniques such as mass spectrometry and biophysical assays. The second section applies these methods to real-world scenarios, focusing on drug discovery, clinical evaluation, and commercial considerations in drug development. Authors Jennie R. Lill and Wendy Sandoval provide clear guidance tailored to the evolving demands of therapeutic innovations such as structural characterization, high-throughput biophysical assays, and RNA-based therapeutics. \u003c\/p\u003e\u003cp\u003eEquipping researchers with the knowledge to navigate the challenges posed by increasingly complex biologics, \u003ci\u003eCharacterizing Biotherapeutics: Analytical Methods for Diverse Modalities:\u003c\/i\u003e \u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eDiscusses new and emerging biological molecule diversity and both traditional analytical methods\u003c\/li\u003e \u003cli\u003eProvides characterization strategies for large molecule (protein\/antibody) based therapeutics\u003c\/li\u003e \u003cli\u003eSummarizes cutting-edge technologies for novel modalities and antibody protein therapeutics\u003c\/li\u003e \u003cli\u003eIncorporates the latest advancements in mass spectrometry, functional assays, and biophysical methods\u003c\/li\u003e \u003cli\u003eAddresses specialized analytical issues for membrane proteins and other challenging targets\u003c\/li\u003e \u003cli\u003ePresents methodologies for assessing safety and therapeutic potential\u003c\/li\u003e\n\u003c\/ul\u003e \u003cp\u003e\u003ci\u003eCharacterizing Biotherapeutics: Analytical Methods for Diverse Modalities\u003c\/i\u003e is an essential reference for analytical scientists, biologists, and mass spectrometrists involved in biomolecule analysis. It is also a valuable resource for graduate students taking advanced courses in biotechnology, drug development, and biotherapeutic analysis, as well as professionals in biotechnology and pharmaceutical industries working to advance biotherapeutic research and development.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47988903051493,"sku":"NP9781394236114","price":215.0,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9781394236114.jpg?v=1761781987","url":"https:\/\/k12savings.com\/es\/products\/characterizing-biotherapeutics-isbn-9781394236114","provider":"K12savings","version":"1.0","type":"link"}