Novel Functional Strategy for Development of Highly Specific Antibody Drug Conjugates for Non-Hodgkin's Lymphoma

10th Annual PEGS Europe 2018

Protein & Antibody Engineering Summit

Abstracts

Lisbon , Portugal 12 - 16 November 2018

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NOVEL FUNCTIONAL STRATEGY FOR DEVELOPMENT OF HIGHLY SPECIFIC ANTIBODY DRUG CONJUGATES FOR NON-HODGKIN'S LYMPHOMA ...... 1 A. Andre, J. Dias, S. Aguiar, S. Oliveira, J. Ministro, L. Gano, J. Correia, L. Tavares, F. Aires-da-Silva

MAX RANDOMISATION: DESIGNED, NON-DEGENERATE SATURATION MUTAGENESIS OF ARMADILLO REPEAT PROTEINS ...... 3 A. Chembath, M. Ashraf, B.P.G. Wagstaffe, Y. Stark, A. Pluckthun, A.V. Hine

NOVEL MULTIMERS OF BICYCLIC PEPTIDES CLUSTER AND ACTIVATE CD137 (4- 1BB): A COSTIMULATORY T CELL CHECKPOINT RECEPTOR ...... 4 L. Chen, J. Kristensson, G. Mudd, H. Harrison, R. Lani, K. McDonnell, P. Upadhyaya, F. An, J. Lahdenranta, P. Park, N. Keen, K. Hurov

INFLUENCE OF CULTURE MEDIA COMPONENTS ON ANTIBODY GLYCOSYLATION PATTERN ...... 5 D. Choi, W. Kang, J. Lee, G.H. Lee, J.H. Kim, W.S. Choi

ABDURIN DRUG CONJUGATES: SMALL IN SIZE AND LONG HALF-LIFE TO IMPROVE LIFE TO IMPROVE ...... 6 J.W. Choi

TARGETED DELIVERY OF ENDOSOMAL TOLL-LIKE RECEPTOR AGONISTS TO THE TUMOUR MICROENVIRONMENT FOR THE PROMOTION OF ANTI-TUMOUR IMMUNITY ...... 7 D. Corogeanu, A. Beavil, S.N. Karagiannis, J.N. Arnold, S.S. Diebold

DEVELOPMENT OF A CAPILLARY ISOELECTRIC FOCUSING (CIEF) METHOD FOR CHARGE ANALYSIS OF NOVEL BIOTHERAPEUTICS ...... 8 J. Cummins, N. Farrands, A. Splevins

DEVELOPMENT OF A BLOOD-BRAIN BARRIER-PENETRATING ANTICALIN FOR NON- INVASIVE BRAIN DRUG DELIVERY ...... 9 F.C. Deuschle, A. Skerra

A NOVEL ULTRA-HIGH THROUGHPUT SCREEN FOR MICROBIAL TRANSGLUTAMINASE ...... 10 L. Deweid, H. Kolmar

AUTOMATED ONE-TO-ONE LINKAGE OF PROTEINS AND PAYLOADS ...... 12 I. Dovgan, A. Hentz, O. Koniev, A. Ehkirch, S. Ursuegui, S. Delacroix, M. Riomet, F. Taran, S. Cianferani, S. Kolodych, A. Wagner

ISOLATION OF CHICKEN-DERIVED ANTIBODY FRAGMENTS USING YEAST SURFACE DISPLAY ...... 13 A. Elter, J. Grzeschik, S. Hinz, D. Yanakieva, S. Krah, T. Zollmann, G. Schwall, S. Zielonka, H. Kolmar

MULTIFUNCTIONAL BIOLOGICS BASED ON IN VIVO MATURED 100% HUMAN VH DOMAINS ...... 14 C. Enever, J. Legg, B. McGuinness, P. Bland-Ward, P. Pack CELL-BASED ASSAYS FOR SCREENING AND CHARACTERISATION OF ANTIBODY- DRUG CONJUGATES ...... 15 R. Forfar, S. Leonard, D. Moore, J. Large, C. Fernandes, R. Brown, C. Southern, D. Matthews, L. Friis, D. Taylor

HIGH THROUGHPUT SELECTION OF HUMAN ANTIBODIES WITH ENHANCED DEVELOPABILITY PROPERTIES ...... 16 T. Gallagher, C. Sellick, V. Germaschewski, R. Williams, S. Suhr, D. Melvin

THE USE OF IN VITRO ASSAYS TO REDUCE THE RISK OF UNWANTED IMMUNOGENICITY AND ACCELERATE CANCER IMMUNOTHERAPY DEVELOPMENT ...... 17 S. Giltaire, J. Lamy, T. Janss, T. Jonckheere, S. Pattijn

ABGENESIS: AN INTEGRATED COMPUTATIONAL SOFTWARE EXPLORING NEW DEPTHS IN ANTIBODY AND IMMUNE REPERTOIRE SEQUENCE ANALYSIS ...... 18 J. Glanville, D. Maurer, S. Youssef, S. Ives, C. Pettus, R. Newland, V. Chou, K. Hervold, C. Smith, G. Day, C. Jones, S. Daraeikia, A. Sanchez, J. Brysting

DRUG CONJUGATES BASED ON ENGINEERED AFFIBODY MOLECULES ...... 19 T. Graslund, M. Altai, H. Liu, H. Ding, B. Mitran, P.H. Edqvist, V. Tolmachev, A. Orlova

NOVEL CELL CULTURE SYSTEM FOR LONG TERM STABLE IGG AND PROTEIN PRODUCTION ...... 20 M. Hagihara, S. Ohya, T. Harada, S. Yamada

IMPLEMENTATION OF GENETIC CIRCUITS IN THE YEAST SACCHAROMYCES CEREVISIAE FOR TIGHTLY REGULATED GENE EXPRESSION ...... 22 D. Happel, A. Hofmann, A. Christmann, H. Kolmar

RAPID ONLINE AND INPROCESS CHARACTERIZATION OF CETUXIMAB FD- GLYCOPROFILE BY DIRECT MONITORING AND CONTROL ...... 23 M. Hedstrom, S. Bjork, D. Erlandsson, M. Westesson, B. Mattiasson

PREDICTING PROTEIN-PROTEIN BINDING SITES AND EPITOPE MAPPING ...... 25 A. Henry, N. Thorsteinson, A. Ajamian, J. Gunn, P. Labute

DEVELOPMENT AND EVALUATION OF T-ZAP2, A NOVEL ANTIBODY-DRUG CONJUGATE FOR THE TREATMENT OF HER2 POSITIVE BREAST CANCER ...... 26 R.M. Hoffmann, S. Crescioli, D. Thurston, S. Karagiannis

PASYLATED COLCHICALIN - A POSSIBLE ANTIDOTE FOR ACUTE COLCHICINE INTOXICATION WITH OPTIMIZED PHARMACOKINETICS ...... 27 E. Ilyukhina, M. Barkovskiy, M. Dauner, A. Eichinger, J. Stenzel, N. Jung, H. Neuberger, F. Eyer, A. Skerra

SELECTION OF SCAFFOLD PROTEINS FOR ANTIBODY MIMETICS ...... 28 T. Ito, H. Nishi, T. Kameda, T. Niide, H. Nakazawa, M. Umetsu

APPRAISAL OF LEUCINE-RICH ALPHA-2-GLYCOPROTEIN 1 (LRG1) AS A TARGET FOR A POTENTIAL ANTIBODY-DRUG CONJUGATE (ADC) ...... 29 F. Javaid, S.E. Moss, J. Greenwood, V. Chudasama

ANTIBODY-MEDIATED INHIBITION OF PEPTIDYL ARGININE DEIMINASE (PPAD) FROM PORPHYROMONAS GINGIVALIS ...... 30 J.Z. Kaczmarek, J.Z. Kaczmarek, D.N. Larsen, B. Szmigielski, J. Potempa, P.D. Skottrup, P. Hojrup DRUG-TARGET-COMPLEX SPECIFIC ANTIBODIES FOR PHARMACOKINETIC ANALYSIS OF BIOTHERAPEUTICS ...... 32 S.J. Kellmann, C. Frisch, S. Harth, A. Knappik

APPLICATIONS FOR HYPERIMMUNE, AUTOIMMUNE DIVERSIMAB™ MICE IN ANTIBODY DISCOVERY ...... 33 R.P. Kelly, B. Bouchard, R. Abdullah, R. Sahoo, R. Subburathinam, A. Bemis, K. Teague, E. Batitay, H. Wagner, J. Gabriel, C. Souders, T. Mullen, G. Hilow, D. Turner

OBTAINING OF A PROTEIN WITH MOLECULAR RECOGNITION BY GRAFTING A FUNCTIONAL PEPTIDE SEQUENCE WITH THE SAME SECONDARY STRUCTURE ...... 34 M. Kikuchi, T. Niide, H. Nakazawa, H. Imanaka, M. Umetsu

INTEGRATED EARLY STAGE DEVELOPMENT STRATEGY AS RISK MANAGEMENT TOOL FOR GLOBAL DEVELOPMENT ...... 35 N. Kinsella, J.B. Holz

NATURAL AND FULLY HUMAN ANTIBODIES FOR DIAGNOSTICS AND THERAPY ...... 36 J. Kugler

MINIATURIZATION AND OPTIMIZATION OF A TWO-PLASMID EXPRESSION PATHWAY IN MYTXTL® CELL-FREE PROTEIN EXPRESSION KIT (ARBOR BIOSCIENCES) USING LABCYTE ECHO® ACOUSTIC TECHNOLOGY ...... 37 A. Lehto, E. Eggenstein, J. Bailey, J.M. Rouillard, J. Lesnick

HOS BIOSIMILARITY AND COMPARABILITY: OBJECTIVE, QUANTIFIABLE HOS COMPARISONS - A BIOSIMILAR CASE STUDY UTILIZING CIRCULAR DICHROISM ...... 38 T. Lester, M. Textor

DESIGNING AN ARTIFICIAL GOLGI REACTOR FOR CELL-FREE GLYCOSYLATION ...... 39 E. Makrydaki, I.M. Ramirez, L. Bouche, S. Haslam, C. Kontoravdi, K.M. Polizzi

BINDERS FOR CHALLENGING TASKS - A HIGH-THROUGHPUT DARPIN SELECTION PIPELINE ...... 41 J. Marinho, T. Reinberg, S. Furler, C. Thom, K. Schlinkmann, M. Goranson, T. Looser, R. Degen, J.V. Schaefer, B. Dreier, A. Pluckthun

BIOCATALYTIC SYNTHESIS OF L-METHIONINE VIA ENZYMATIC CO[2] FIXATION ...... 42 J. Martin, L. Eisoldt, A. Skerra

ABDURIN: A NEW SMALL SIZE AND LONG HALF-LIFE TOOL IN DIFFERENT FORMATS ...... 43 A. Missineo, S. Peretti, L. Tomei, A. Demartis, S. Sambucini, C. Nardi, E. Beghetto, R. Sasso, F. Colaceci, C. Terzo, P. Di Pasquale, E. Monteagudo, A. Jenkins, D. Morris, M. Frigerio, M. Bird, G. Badescu, C. Souvignier, K. Gehlsen

BACKBONE CIRCULARIZATION COUPLED WITH OPTIMIZATION OF CONNECTING SEGMENT IN EFFECTIVELY IMPROVING THE STABILITY OF G-CSF ...... 44 T. Miyafusa, R. Shibuya, W. Nishima, R. Ohara, C. Yoshida, S. Honda

END-TO-END WORKFLOW PLATFORM FOR INTEGRATED BIOPHARMACEUTICAL DEVELOPMENT ...... 45 M. Moravec, S. Schlicker, J. Terragni, A. Lynch, M. Wendt, H.P. Fischer

A QUANTITATIVE MS-BASED MULTI-ATTRIBUTE METHOD (MAM) APPROACH FOR NEW BIOLOGICAL ENTITIES AND BIOSIMILAR CANDIDATES PRESENTED BY A FULL METHOD QUALIFICATION FOR AN IGG1 MARKET PRODUCT ...... 46 M. Mreyen, A. Schnabel, G. Korting, J. Bruckner, Y. Jasper, H. Falkenberg, R. Moussa A NOVEL METHOD FOR QUANTIFICATION OF ADCC ACTIVITY BASED ON THE USE OF ENGINEERED EFFECTOR CELLS AND A SERIES OF MATCHING TARGET CELLS ...... 47 L. Naylor, L. Frier-Bovin, K. Blume, T. Segerstein, A. Pramhed

MULTI-CRITERIA DECISION-MAKING TOOLS TO SELECT OPTIMAL THERAPEUTIC PROTEINS FOR SUCCESSFUL DEVELOPMENT AND MANUFACTURING ...... 48 O. Obrezanova, S. Georgiev, G. Montague, R.G. de la Cuesta, S. Preiksaite, Y. Stallwood, J. O'Hara, B. Sweeney, A. Turner, K. Tyson, J. Zurdo

A NOVEL CEACAM1-TARGETING ANTIBODY AS A MULTIFUNCTIONAL BLOCKER...... 49 M.Y. Oh, S.Y. Eun, H.Y. Park, H.M. Nam, J.C. Lee, S. Kim, D.S. Kim, J. Won, B.H. Oh

MACHINE-LEARNING-GUIDED MUTAGENESIS PLATFORM FOR DESIRED EVOLUTION: IN THE CASE OF FLUORESCENT PROTEIN? ...... 50 M. Oikawa, H. Nakazawa, T. Niide, T. Kameda, Y. Saito, K. Tsuda, M. Umetsu

DEVELOPMENT OF A HIGH-THROUGHPUT MULTIPLEX MOUSE IGG ISOTYPING AND QUANTITATION ASSAY ...... 51 J. O'Rourke, Z. Liu

ADVANCED CHO CELL EXPRESSION SYSTEM FOR INCREASED TRANSIENT PROTEIN PRODUCTION ...... 53 M. Porte, J. Havard, M. Tournoux, G. Guerin-Peyrou, P. Erbacher

COMBINATION OF RIBOSOME DISPLAY AND NEXT GENERATION SEQUENCING AS A POWERFUL METHOD FOR IDENTIFICATION OF AFFIBODY BINDERS AGAINST CTX- M15 ...... 54 S. Potisopon, P. Lagoutte, C. Elie, S. Donnat, C. Mignon, B. Werle

DEVELOPMENT OF AN ANTIBODY RADIOLABELED DRUG CONJUGATE (ARDC) USING 195MPT-CARBOPLATIN FOR THERANOSTIC APPROACH IN OVARIAN CANCER...... 55 L.M. Recnik, C. Cantelli, I. Teulon, J.P. Pouget, V. Lisowski

MODELING CRYSTAL GROWTH IN LYOPHILIZATION VIALS TO ANTICIPATE HURDLES WITH FREEZE DRIED PRODUCTS ...... 57 M.A. Rodrigues, S.D. Castro, P.S. Rego, V. Geraldes

ENGINEERING PHAGE-DISPLAYED HUMAN INTERLEUKIN-2 FOR BETTER DEVELOPABILITY: DIRECTED EVOLUTION OF SUPER-SECRETED VARIANTS ...... 58 G. Rojas, T. Carmenate, J.F. Santos-Tomas, P.A. Valiente, M. Becker, A. Perez-Riveron, Y. Tundidor, Y. Ortiz, J.F.D. Cossio-Diaz, L. Graca, S. Dubel, K. Leon

AUTOMATED DATA PROCESSING AND ANALYSIS FOR QUALITY MONITORING OF BIOTHERAPEUTICS BY MULTI-ATTRIBUTE METHOD (MAM) ...... 59 C. Schmid, P. Haberl, S. Gotta, D. Mertens, A. Brandenburg

MEMOMAB, A NOVEL TECHNOLOGY FOR BANKING AND SCREENING OF COGNATE ANTIBODY REPERTOIRES ...... 60 S. Schmitt, J. Rutkauskaite, M. Weber, A. Guimaraes, E. Foster, K. Stettler, C. Esslinger

EVALUATION OF PROBIOTICS AND PLANT-DERIVED INGREDIENCES IN COMPOSING A NEW GENERATION, HUMAN-FRIENDLY CLEANING FORMULAS ...... 61 P. Skowron, J. Jezewska-Frackowiak, J. Zebrowska, M. Fiutak, G. Jedrzejczak, M. Peska, J. Jasinska FLUORESCENT NANOPARTICLES-BASED NEW TECHNOLOGY: PRELIMINARY STUDIES FOR FUTURE APPLICATIONS AS DIAGNOSTIC TOOL AND DRUG CARRIER ...... 63 F. Sola, A. Volpe, V. Calabrese, R. Juris, C. Barattini, B. Canonico, S. Papa, A. Ventola

FUNCTIONALIZATION OF AN ANTICALIN® SCAFFOLD WITH NON-CANONICAL AMINO ACIDS TO TARGET SPECIFIC SUGAR STRUCTURES ON TUMOR CELLS ...... 65 C.A. Sommer, S. Edwardraja, A. Eichinger, I. Theobald, A.J. Reichert, A. Skerra

CHEMO-BIO PHAGE LIBRARY APPROACH FOR GENERATING PEPTIDE-DRUG CONJUGATE ...... 66 T. Takahashi, T. Niide, H. Nakazawa, H. Imanaka, M. Umetsu

THE JOURNEY TO “THE” ANTIBODY: ACCESSING A VERSATILE TOOLBOX ...... 67 D. Teixeira, J. Assuncao, I. Toth, A. Barroso, M. Gonzalez-Pajuelo, J. Santos, D. Ramos, J. Queiroz, D. Pinto, A. Kelly

VALIDATION OF A NEW METHOD TO CHARACTERIZE PROTEOLIPOSOMES IN SOLUTION BY FORCE SPECTROSCOPY WITH ATOMIC FORCE MICROSCOPY ...... 68 B. Tillier, S. Cortes, J. Chlasta, G. Runel

EVOLUTION OF ARTIFICIAL NUCLEIC ACID REPLICATIVE POLYMERASES ...... 69 L.L. Torres, V.B. Pinheiro

DEVELOPMENT OF ANTIBODY-DRUG CONJUGATES THAT USE ACTIN-TARGETING WARHEADS ...... 70 D. Trofimova, R. Grange, M. Aeluri, R. Williams, S. Nersesian, A. Craig, A. Evans, J. Allingham

SMART HOT LIBRARY APPROACH FOR GENERATING CROSS-ACTIVE ANTIBODY ...... 71 M. Umetsu, S. Hattori, T. Hattori, Y. Kato, H. Nishi, J. Yamaguchi

NOVEL BICYCLIC PEPTIDE PLASMA KALLIKREIN INHIBITORS IDENTIFIED BY A COMBINATION OF PHAGE DISPLAY SELECTIONS AND RATIONAL-DESIGN MEDICINAL CHEMISTRY ...... 72 M. Vanhove, D.P. Teufel, G. Bennett, H. Harrison, K. van Rietschoten, S. Pavan, C. Stace, T. Van Bergen, E. Vermassen, P. Barbeaux, T.T. Hu, J.H.M. Feyen

MOLECULAR INTERACTION ANALYSIS BY GRATING-COUPLED INTERFEROMETRY (GCI) ...... 73 M. Vegh, J. Galindo, F. Andres, F. Spiga

BIOLUMINESCENT ASSAYS FOR T-CELL RESPONSIVENESS: FROM CHANGES IN METABOLISM TO TARGET SPECIFIC CELL KILLING ...... 74 J. Vidugiriene, P. Hofsteen, M. Valley, N. Karassina, D. Leippe, J. Cali

FLUORESCENT NANOPARTICLES AS TOOL FOR NEXT GENERATION ADCS: SITE- SPECIFIC ANTIBODY CONJUGATION STRATEGIES FOR HIGHLY PURE TARGETING SYSTEMS AND ACCURATE DETECTION OF DRUG DELIVERY ...... 75 A. Volpe, C. Pellegrino, V. Calabrese, F. Sola, C. Barattini, A. Ventola

TRYPCO TECHNOLOGY: A VERSATILE TOOL FOR SITE-SPECIFIC GENERATION OF ADCS ...... 77 R. Wartner, M. Boehme, A. Simon, C. Meyer, F. Dittrich, S. Liebscher, F. Bordusa

RAPID GENERATION OF TOOLS FOR MEASURING THERAPEUTIC ANTIBODY/DRUG- TARGET COMPLEXES FOR REAL TIME MONITORING AND PK ASSAYS ...... 78 A. Wilcox, R. Ford, A. Davidson, M. Johnson A SIMPLE SCREENING METHOD DESIGNED TO IMPROVE THE EFFICIENCY OF REAGENT SELECTION AND OPTIMIZATION FOR THE DEVELOPMENT OF NO-WASH MULTIPLEXED IMMUNOASSAYS ...... 79 P.G. Wylie, D.J. Onley, A.F. Hammerstein, D.M. Lathlean

TARGETED INTEGRATION OF HOTSPOT IN CHO GENOME FOR RAPID GENERATION OF STABLE AND HIGH LEVEL MONOCLONAL ANTIBODY PRODUCING CELL LINES ...... 80 Y. Yang

A CHEMICALLY-DEFINED BACULOVIRUS-BASED EXPRESSION SYSTEM FOR ENHANCED PROTEIN PRODUCTION IN SF9 CELLS ...... 81 M. Yovcheva, S. Barnes, K. Thompson, M. Cross, K. Irvin, N. Lucki, H. Chiou, J. Zmuda

LMO2-DEPENDENT LEUKEMIA STEM CELL SURFACEOME REVEALS UPREGULATED T CELL BIOMARKERS FOR SURVEILLANCE AND POTENTIAL IMMUNOTHERAPY TARGETS ...... 82 J. Zhang, H. Pais, K. Ruggero, O. Al-Assar, N. Bery, V. Weston, P.R. Kearns, C. Mecucci, A. Miller, T.H. Rabbitts

NOVEL PENDANT TYPE POLY(ETHYLENE GLYCOL) LINKER FOR ANTIBODY DRUG CONJUGATES ...... 84 D. Zucker, K. Yoshimura, Y. Matsuno, A. Suzuki, M. Shishido, T. Tsubusaki, S. Yoshimura, Y. Yamamoto

ACCELERATE KINETIC SCREENING AND EPITOPE CHARACTERIZATION OF ANTIBODY LIBRARIES WITH ARRAY SPR ...... 85 Y. Abdiche

MULTI ATTRIBUTE MONITORING (MAM) AT THE INTACT, SUBUNIT AND PEPTIDE LEVEL UNDER REGULATORY COMPLIANCE ...... 86 C. Albers, D. Suckau, A. Resemann, G. Tremintin

ANTI-HUMAN CXCR4 AND ANTI-HUMAN IL-7R ANTIBODIES SELECTED FROM NON- IMMUNE REPERTOIRES ...... 87 J. Assuncao, I. Toth, A. Pica-Milho, J. Queiroz, P. Canhao, F. Martins, D. Ramos, A. Barroso, D. Teixeira, M. Gonzalez-Pajuelo

ADVANCED ANTIBODY ANALYSIS OF NGS AND SANGER DATA FROM SELECTION AND SCREENING PROJECTS ACCELERATE THERAPEUTIC ANTIBODY DISCOVERY ...... 88 J. Bendtsen

RAPID ON-COLUMN DIGESTION FOR AUTOMATED MONOCLONAL ANTIBODY ANALYSIS ...... 89 S. Bjork, A. Nageli, M. Nordgren, L. Andersson, H. Nyhlen, J. Sjogren, F. Olsson

MULTI-SPECIFIC ANTIBODY TECHNOLOGY ENGAGING NK CELLS IN ONCOLOGY ...... 90 A. Blanchard-Alvarez, B. Rossi, C. Cesari, F. Bosco, M. Sapet, G. Grondin, S. Cornen, S. Ingoure, C. Delcambre, L. Volmy, A. Morel, E. Vivier, L. Gauthier

ENGINEERING OF A HUMAN COMMON LIGHT CHAIN TO INCORPORATE PH- RESPONSIVE BINDING MODALITIES INTO A CEACAM5 SPECIFIC ANTIBODY ...... 91 J. Bogen, S.C. Hinz, A. Ebenig, S. Becker, H. Kolmar, S. Krah, S. Zielonka

HUMANIZATION OF ANTIBODIES USING A STATISTICAL INFERENCE APPROACH ...... 93 P. Bruscolini, A. Clavero-Alvarez, T. Di Mambro, S. Perez-Gaviro, M. Magnani, P. Bruscolini ONE-STEP DIFFERENTIATE, EXPAND, AND ARM CD8+ CD3+ T CELLS BY ANTI- TUMOR/ANTI-CD3 BISPECIFIC ANTIBODY FOR ADOPTIVE T CELL THERAPY ...... 94 Y.J. Chen, K.H. Chuang

EXTRACELLULAR SECRETION OF SINGLE-CHAIN VARIABLE FRAGMENT AGAINST AFLATOXIN B1 USING RECOMBINANT ESCHERICHIA COLI ...... 95 D. Choi, I. Yeo, Y. Jeon, S.G. Kim

AUTOMATED DIGESTION FOR PEPTIDE MAPPING ...... 96 M. Christiansen, K. Cook, J. Bones, S. Carillo, C. Jakes

NON-COVALENT MODIFICATION OF MPEGYLATED NANODRUGS BY TRISPECIFIC ANTIBODY TO SIMULTANEOUSLY ELIMINATE TUMORS AND TUMOR ASSOCIATED FIBROBLASTS ...... 97 K.H. Chuang

UTILIZATION OF THE OMNICHICKEN™ PLATFORM TO DERIVE FUNCTIONAL THERAPEUTIC ANTIBODY CANDIDATES AGAINST A TRANSMEMBRANE PROTEIN TARGET ...... 98 E. Collarini, D. Pedersen, K. Bender, K. Fong, E. Collarini, J. Damiano, S. Izquierdo

NOVEL WORKFLOW TO INTRODUCE ION EXCHANGE CHROMATOGRAPHY OF BIOPHARMACEUTICAL PROTEINS INTO HIGH RESOLUTION MASS SPECTROMETRY ...... 99 K. Cook, J. Bones

ENGINEERING Q-TAG ON VARIOUS POSITIONS OF RECOMBINANT PROTEINS FOR SITE-SPECIFIC LABELING WITH KALB TRANSGLUTAMINASE ...... 100 R. Corpuz, M. Wong, J. Low, W. Steffen, M. Schraeml

ANTAGONIST ANTI-TIGIT ANTIBODY, EOS884448, SHOWS ANTI-TUMOR EFFICACY BY RESTORATION OF T-CELL EFFECTOR FUNCTION AND PREFERENTIAL TREG DEPLETION ...... 101 J. Cuende, C. Hoofd, V. Rabolli, J. Preillon, N. Wald, L. Garnero, F. Lambolez, S. Prassad, M. Mercier, F. Nyawouame, S. Denies, M. Brouwer, E. Houthuys, V. Bodo, X. Leroy, O. de Henau, S. Chappel, M. Detheux, G. Driessens

THE CHAIN ASSOCIATION ISSUE IN TRISPECIFIC ANTIBODIES: RESOLVING THE PUZZLE BY MULTI-ARRAY TECHNOLOGY ...... 103 O. Demirel, A. Tomasovic, A. Lygina, U. Roth, D. Usener

BIOPHYSICAL CHARACTERIZATION OF ALPHABODY-BCL9(L) INTERACTIONS ...... 105 E. Deyaert, S. Loverix, J. Desmet, S. Deroo, S. Pandolfi, P. Alard, L. Wurth, T. Girardi, K. Vandenbroucke, P. Hendrickx, I. Lasters, Y. McGrath

DEVELOPMENT OF AN AUTOMATED, 384-WELL HUMIRA PROFILING BIOASSAY USING A LABCYTE® ECHO® LIQUID HANDLER ...... 106 D. Donnelly, J. Lesnick, A. Lejeune-Dodge

IMPROVED CHO CELL LINE DEVELOPMENT: COMBINED UCOE® TECHNOLOGY AND CHOZN® PLATFORM ...... 107 R. Ebel, K. Mann, J. Stoner, P. Kumpey, D. Silva, K. Achtien, B. Anderson, K. Reger, F. Stewart, K. Cunningham, T. Borgschulte, J. Orlando

EXPLORING MOLECULAR INTERACTIONS ON SUSPENSION CELLS: REAL-TIME CELL-BASED ASSAYS WITH LIGAND TRACER TECHNOLOGY ...... 108 J.C. Encamacao, S. Bondza, H. Bjorkelund, J. Buijs, K. Andersson IMPROVED 2G UNIC™ VECTORS FOR ENHANCED PROTEIN PRODUCTION UNDER GS SELECTION IN CHO-S AND CHO GS -/- CELLS ...... 109 B. Engels, A. de Jel, C. Tilburgs, T.J.A. Gonzalez, M.V.D. Heijden

OPTIMIZING SPRAY DRYING OF BIOPHARMACEUTICALS USING DIFFERENTIAL SCANNING FLUORIMETRY ...... 110 D.A. Fernandes, E. Costa, P. Leandro, M.L. Corvo

LABEL-FREE BINDING STUDY BETWEEN A HIGH AFFINITY GUINEA PIG MONOCLONAL ANTIBODY AND A STEROID HORMONE ...... 112 C. Frydman, K. Mercier, P.E. Baurand, Y. Nizet, P. Dulieu

IMPROVING BIOLOGICS WORKFLOW: DETAILED CHARACTERIZATION OF QUALITY, BINDING AND STABILITY OF MABS ...... 113 P. Fuang, P. Piatti, M. Mohamadi, N. Tschammer, B. Kern, P. Linke, A. Schulze, F. Soltl, P. Garidel, M. Blech

AN AUTOMATED APPROACH FOR COMPREHENSIVE CHARACTERIZATION AND QUANTIFICATION OF LOW-ABUNDANCE SEQUENCE VARIANTS IN A STANDARD MONOCLONAL ANTIBODY ...... 114 P. Haberl, S. Gotta, C. Schmid, D. Mertens, A. Brandenburg

GENERATION OF A SEMI-SYNTHETIC COMBINED LIBRARY TOWARDS NOVEL BIPARATOPIC BINDERS ...... 115 J. Habermann, J. Grzeschik, M. Traxlmayr, H. Kolmar

SHARK-ANTIBODY DERIVED BIOMOLECULES FOR DOWNSTREAM PROCESSING ...... 117 S.C. Hinz, A. Elter, J. Grzeschik, S. Zielonka, G. Schwall, H. Kolmar

AFFINITY MATURATION AND VALIDATION OF A COL6A3-002-SPECIFIC T CELL RECEPTOR FOR IMPROVING PERFORMANCE IN ADOPTIVE CELL THERAPY ...... 118 M. Hutt, F. Unverdorben, M. Hofmann, L. Alten, C. Wagner, H. Schuster, O. Schoor, T. Weinschenk, C. Reinhardt, D. Maurer, S. Bunk

HIGH RESOLUTION NATIVE MASS SPECTROMETRY FOR CHARACTERIZATION OF ANTIBODY BIOPHARMACEUTICALS ...... 119 P.F. Jensen, T.M. Sloth, M. Orgaard, J. Wagtberg, D.B. Kristensen

MEASUREMENT OF TARGET CELL-SPECIFIC KILLING USING A NOVEL HIGHLY SENSITIVE BIOLUMINESCENT ASSAY ...... 120 G. Jochems, B. Binkowski, C. Eggers, A. Paguio, P. Stecha, B. Butler, Z.J.J. Cheng, M. Cong, F. Fan

HIGH YIELD PEPTIDE EXPRESSION AND PURIFICATION TECHNOLOGY FOR RECOMBINANT PRODUCTION OF PEPTIDE BIOTHERAPEUTICS ...... 121 S.G. Kim, S. Kim, K.Y. Park

SEQUENTIAL AFFINITY IMPROVEMENT VIA AFFINITY MATURATION AND SITE- DIRECTED MUTAGENESIS OF SINGLE-CHAIN VARIABLE FRAGMENT AGAINST AFLATOXIN B1 ...... 122 Y.J. Kim, S.G. Kim

INDUSTRIALIZING IO THERAPEUTIC DISCOVERY PLATFORMS: MULTISPECIFICS, ENGINEERED TCRS AND CARS ...... 123 S. Kolinko, K. Maillard, C. Smith, A. Lynch, G. Cappuccilli, H.P. Fischer, M. Wendt NOVEL METHODOLOGY AND WORKFLOW FOR TRACKING MEDIA, AGGREGATING ASSAY DATA, AND TRACKING LINEAGE OF EXPRESSION SYSTEM SAMPLES FOR BOTH INDIVIDUAL OR MULTIPLE BIOREACTOR RUNS ...... 124 J. Leadley, R. Luce, S. Hert, K. Krouse, M. Yukubousky, J. Murray, A. Taylor, R. Ketchem

THERAPEUTIC ANTIBODY FRAGMENTS PRODUCTION CASE STUDY: EARLY CONSIDERATIONS FOR COST EFFECTIVE PRODUCTION, PURIFICATION AND QUALITY ...... 125 K. Lebozec, O. Favre-Bulle, L. Jullien, G. Avenard, M. Jandrot-Perrus, P. Billiald

OVERCOMING UNUSUAL CHALLENGES IN THE CHARACTERIZATION OF MONOCLONAL ANTIBODIES BY MASS SPECTROMETRY IN EARLY AND LATE PHASE ...... 126 N. Lechat, B. Genet, A. Martelet, S. Clavier

HUMAN ANTIBODIES FROM TRANSGENIC CHICKENS ...... 127 P. Leighton, K. Ching, K. Berg, J. Morales, B. Harriman, Y. Abdiche

LARGE-SCALE DETERMINATION OF AFFINITY, SPECIFICITY, AND KINETICS OF COMPLEX ANTIBODIES: AUTOMATING DATA ANALYSIS AT PACE WITH THE NEW POSSIBILITIES ...... 128 O. Leven, S. Steigele, L. Florez, M. Ginkel, R. Emkey, L. Foster, S. Heyse

DEVELOPMENT OF A HIGH-THROUGHPUT ANTIBODY ENGINEERING AND EXPRESSION PROFILING PLATFORM - CELLECTIVE BIOTHERAPY CASE STUDY ...... 129 V.R. Leydon, M. Baker, S. Clerkin, L. Flanagan, T. Jones, Q. Liu, V. Martin, A. Marsden, S. Pollack, T.F. Tedder, T. Payne, R. Cawood

STRATEGIES FOR HIGH-TITER PROTEIN EXPRESSION USING THE EXPICHO AND EXPI293 TRANSIENT EXPRESSION SYSTEMS ...... 130 C.Y. Liu, J. Liu, W. Yan, K. Williston, K. Irvin, H. Chou, J. Zmuda

HIGH-THROUGHPUT ANTIBODY ENGINEERING IN MAMMALIAN CELLS BY CRISPR/CAS9-MEDIATED HOMOLOGY-DIRECTED MUTAGENESIS ...... 131 D.M. Mason, C.R. Weber, C. Parola, S.M. Meng, V. Greiff, W.J. Kelton, S.T. Reddy

DEVELOPMENT OF PEPTIDE VACCINE THERAPY TARGETING COLON CANCER STEM CELLS WITH HLA LIGANDOME ANALYSIS ...... 132 S. Miyamoto, T. Kanaseki, A. Miyazaki, T. Torigoe

PROTEIN PRODUCTION, KINETIC PROFILING AND X-RAY CRYSTALLOGRAPHY FOR BIOLOGICALS VERSUS SMALL MOLECULES DURING EARLY DRUG DISCOVERY - SIMILARITIES AND DIFFERENCES ...... 133 I. Montenbruck, T. Hage, K. Maskos, S. Krapp, L. Neumann, S. Hoppner, C. Donat

RAPID GENERATION OF PEPTIDE-MHC COMPLEXES WITH DISULFIDE-STABILIZED EMPTY HLA-A*02 MOLECULES FOR HIGH THROUGHPUT KINETIC SCREENINGS ...... 134 A. Moritz, M. Hofmann, R. Anjanappa, S. Bunk, C. Wagner, S. Springer, D. Maurer, H.G. Rammensee

CONSISTENT ANTI-IDIOTYPE ANTIBODY DISCOVERY ENABLED BY HYPERIMMUNE MOUSE TECHNOLOGY ...... 135 T. Mullen, R. Kelly, B. Bouchard, R Abdullah, R. Sahoo, R. Subburathinam, A. Bemis, K. Teague, E. Batitay, H. Wagner, J. Gabriel, C. Souders, G. Hilow, D. Turner

EVALUATING A NO-WASH RAPID FCRN IMMUNOASSAY TO GUIDE THE DEVELOPMENT OF ANTIBODY THERAPEUTICS ...... 136 N. Nath, B. Godat, M. Rosenblatt, R. Flemming, M. Urh A NEW T-CELL SIGNATURE TO STUDY T-CELL INFILTRATION OF HUMAN CANCERS: PROGNOSTIC AND PREDICTIVE VALUE ...... 137 G. Nocentini, L. Cari, F. De Rosa, G. Migliorati, C. Riccardi

AN O-GLYCAN SPECIFIC ENDOPROTEASE WITH APPLICATIONS IN GLYCOPROTEIN ANALYSIS USING LC-MS ...... 138 H. Nyhlen, M. Nordgren, S. Bjork, R. Lood, F. Leo, F. Olsson

MURINE IMMUNOGLOBULIN GAMMA 3: A STUDY OF ITS INTERACTION WITH MACROPHAGE RECEPTORS...... 139 D.S.L.D. Oliveira, V. Paredes, A.C.D. Santos, P. Albuquerque, A. Casadevall, M.S.S. Felipe, A.M. Nicola

ROUTINE MONITORING OF T CELL ACTIVATION BY MULTIPLEXING ANALYSIS OF IMMUNOPHENOTYPES AND SECRETED CYTOKINES ...... 141 J. O'Rourke, A. Gomez-Donart, Z. Liu

HIGHLY EFFICIENT KINETIC SCREENING OF HUMANIZED ANTIBODIES FROM CELL CULTURE MEDIUM ...... 142 S. Park, M.H. Sohn, M.S. Lim, S.Y. Choi

GENERATION AND SCREENING OF VARIABLE REGION LIBRARIES IN A MAMMALIAN ANTIBODY DISPLAY PLATFORM ...... 143 C. Parola, S.T. Reddy

CC-1, A BISPECIFIC PSMA ANTIBODY IN AN OPTIMIZED FORMAT FOR TREATMENT OF PROSTATE CANCER AND SQUAMOUS CELL CARCINOMA OF THE LUNG ...... 144 M.S. Pfluegler, F. Vogt, L. Zekri, S.P. Koerner, S. Mueller, G. Jung, H.R. Salih

HUMANIZATION OF FUNCTIONAL ANTIBODIES AGAINST MEMBRANE SPANNING PROTEINS ...... 145 J. Raats, D. Kruijsen, N. Smits

A PLATFORM TECHNOLOGY FOR THE RAPID GENERATION OF ROBUST ANTI- IDIOTYPIC BINDERS FOR CLINICAL PK ASSAYS...... 146 B. Ricketts, R. Ford, J. Nuttall, A. Nicholl, A. Wignall, A. Davidson, H. Curd

HETEROLOGOUS EXPRESSION, PURIFICATION AND CHARACTERIZATION OF THE HUMAN CD20 FULL LENGTH MEMBRANE PROTEIN, DERIVATIVES AND FRAGMENTS IN E. COLI ...... 147 F. Rodewald, A. Schiefner, A. Skerra

CHARACTERIZATION OF AAV STRUCTURE: CAPSID PROTEINS AND NUCLEIC ACID COMPOSITION ON LABCHIP® GXII TOUCH™ PLATFORM ...... 148 N. Rodionova, Z. Peng, E. Miller, M. Nilsson

BOLSTERING THERAPEUTIC EFFICACY AND SPEED TO CLINIC USING NON-VIRAL T- AND NK-CELL ENGINEERING ...... 149 P. Roychoudhury, K. Steger, J. Carmen, R. Shivakumar, J. Brady

NOVEL TCR BASED THERAPY TARGETING CANCER, INFECTIOUS, AND AUTOIMMUNE DISEASES ...... 150 A. Sarkar, L. Godinho, F. Seifert, B. Barnhill, K. Wiseman, A. Modak, I. Yefimenko

ACCELERATING ANTIBODY DRUG DEVELOPMENT WITH SUBDOMAIN-SPECIFIC AFFINITY LIGANDS ...... 151 K. Sleijpen, P. Hermans, F. Detmers, B. Dawson, J. de Rooij CAN SHARK BE HELPFUL IN REACHING THE CNS? AN IN VITRO PERMEABILITY ANALYSIS OF SHARK DOMAIN ANTIBODIES (VNARS) THROUGH THE NASAL RPMI CELL LINE ...... 152 A.S. Zadeh, A.S. Zadeh, J. Flamm, S. Lade, H. Dinter, A. Greasser, M. Lang, K. Schindowski

EMERGING TECHNOLOGY FOR HOS EVALUATION: MORE THAN A-HELIX AND B- SSHEET: EXPANDING THE ROLE OF CIRCULAR DICHROISM ...... 153 M. Textor, T. Lester

PRECLINICAL HUMANIZED MODELS FOR ICP TARGETING COMPOUNDS ...... 154 K. Thiam

EFFICIENT AND CONSISTENT TRANSIENT PROTEIN PRODUCTION USING A HIGH QUALITY READY-TO-USE PEI ...... 155 M. Tournoux, M. Porte, J. Havard, G. Guerin-Peyrou, P. Erbacher

EXPLOITING THE RIBOSOMAL RPL10 R98S MUTATION TO ENHANCE MAMMALIAN RECOMBINANT PROTEIN PRODUCTION ...... 156 B. Verbelen, S.O. Sulima, T. Girardi, S. Cinque, J. Royaert, J. Verbeeck, S. Vereecke, K.R. Kampen, K. De Keersmaecker

A PLATFORM APPROACH TO MANAGE DEVELOPABILITY AND MANUFACTURABILITY RISKS OF BIOLOGICS MOLECULES ...... 157 M. Wendt, G. Cappuccilli, C. Bruder, C. Smith, K. Maillard, H.P. Fischer

IDENTIFICATION OF ANTIBODY MIMICKING PEPTIDE SCAFFOLD FROM IN VITRO AND IN SILICO SELECTION PROCESS ...... 158 S. Yun, S. Lee, J. Choo, E.K. Lee

A NOVEL COMMERCIAL UTILITY OF IPS CELLS: FULLY HUMAN BIOLOGIC MANUFACTURING ...... 159 Y. Zahid, T. Deisher, K. Poulin, P. Jarzyan, K. Koyama

THE ROLE OF THE FH8 TAG IN THE BIOSYNTHESIS AND PURIFICATION OF TRF HUMAN TELOMERIC PROTEINS IN ESCHERICHIA COLI EXPRESSION SYSTEM ...... 160 J. Zebrowska, M. Fiutak, P. Skowron, A. Zylicz-Stachula

EXPI293 TRANSIENT PROTEIN EXPRESSION SYSTEM: NEW TOOLS FOR STRUCTURAL BIOLOGY AND DIFFICULT TO EXPRESS PROTEINS ...... 161 J. Zmuda, C.Y. Liu, W. Yan, J. Liu, K. Irvin, K. Williston, H. Chiou

ATTEMPTS TO PRODUCE HUMAN TELOMERIC PROTEINS TRF1 AND TRF2 IN YEAST EXPRESSION SYSTEM ...... 162 A. Zylicz-Stachula, J. Zebrowska, D. Krefft, M. Prusinowski, M. Witkowska, P. Skowron

A PIPELINE FOR EXPRESSION AND PURIFICATION OF LARGE ION CHANNELS AND TRANSPORTERS FOR CRYO-EM STUDIES ...... 163 W. Abdulrahman, M. Botte, S. Markovic-Mueller, R. Cheng, N. Bocquet, D. Bucher, S. Huber, E. Plichta, M. Hennig

SIMPLE AUTOMATED HIGH YIELD PROTEIN PURIFICATION AND ENZYME PROCESSING ...... 164 A. Alexandrovich, A. Beavil, R. Beavil, M. Gautel

FED-BATCH MICRO PLATE ...... 165 T. Anderlei, T. Keil, B. Dittrich, J. Buchs IMPACT OF OXIDIZED PS80 ON MAB STABILITY ...... 166 H. Audat, B. Thibert, V. Barailles, F. Bensaid, M.D.L.M.S. Pierre, C. Pellet, I. Robineau, C. Narradon, P. Guibal, A. Ribardiere, S. Huille, J.R. Authelin

EVALUATION OF THE MIDDLE EAST RESPIRATORY SYNDROME CORONAVIRUS 4A PROTEIN WILD TYPE AND ITS MUTANTS BINDING AFFINITY TO DSRNA USING STEERED MOLECULAR DYNAMICS SIMULATIONS ...... 167 M. Batool, S. Choi

HERA-CD40L: A UNIQUE HEXAVALENT CD40 AGONIST FOR CANCER IMMUNOTHERAPY ...... 168 K. Billian-Frey

DEVELOPMENT OF A PLATFORM ADCC AND ADCP FLOW CYTOMETRY METHODOLOGY FOR MONOCLONAL ANTIBODIES ...... 170 L. Blackwood, B.J. Tyrrell, L.A. McAleer, K. Chapple

MODIFYING AGGREGATION PROPENSITY OF RECOMBINANT PROTEINS FOR INCLUSION BODY FORMATION THROUGH THE SELECTION OF AGGREGATION- PRONE PEPTIDES BY FLUORESCENCE MICROSCOPY TECHNIQUES ...... 171 J.V.C. Tomas, A. Cisneros, P. Saccardo, M. Roldan, N. Ferrer-Miralles, E. Garcia-Fruitos, A. Aris, A. .Villaverde, J.V.C. Tomas

ANTI-TUMOR EFFICACY OF ANTI-GITR IN PRECLINICAL HGITR MODEL ...... 172 J. Chaix

ANTI-FOLATE RECEPTOR ALPHA-DIRECTED ANTIBODY THERAPIES RESTRICT THE GROWTH OF TRIPLE-NEGATIVE BREAST CANCER ...... 173 A. Cheung, J. Opzoomer, K. Ilieva, P. Gazinska, R. Hoffmann, H. Mirza, A. Grigoriadis, A. Tutt, S. Karagiannis

REGULATORY CROSSTALK BETWEEN LINEAGE-SURVIVAL ONCOGENES KLF5, GATA4 AND GATA6 COOPERATIVELY PROMOTES GASTRIC CANCER DEVELOPMENT ...... 174 N.Y. Chia, N. Deng, K. Das, D. Huang, L. Hu, Y. Zhu, K.H. Lim, M.H. Lee, J. Wu, X.X. Sam, G.S. Tan, W.K. Wan, W. Yu, A. Gan, A.L. Tan, S.T. Tay, K.C. Soo, W.K. Wong, L.T. Dominguez, H.H. Ng, S. Rozen, L.K. Goh, B.T. Teh, P. Tan

INSIGHTS INTO THE STABILITY AND MECHANISM OF UNFOLDING OF A THERAPEUTIC FRAGMENT ANTIBODY BY SAXS AND MD SIMULATIONS ...... 175 N. Codina, D. Hilton, C. Zhang, S. Perkins, P. Dalby

REPRODUCIBLE MOA-REFLECTING REPORTER-BASED BIOASSAYS TO ENABLE DRUG DEVELOPMENT OF BIOSIMILARS AND BIOBETTERS ...... 177 M. Cong, R. Moravac, D. Li, J. Wilkinson, F. Fan

SINGLE STEP VIRUS PURIFICATION WITH A NEW - CALCIUM AFFINITY, CATION EXCHANGE – MIXED-MODE MEDIA ...... 178 J.F. Depoisier

COLD STABILITY ACCELERATOR: A NEW METHOD TO ASSESS THE IMPACT OF COLD AND CRYOPRESERVATIVES ON PROTEIN DISULFIDE ISOMERASE ACTIVITY ...... 179 A. Duarte, C. Correia, E. Tavares, E.P. Melo, M.A. Rodrigues

FUNCTIONAL EDITING OF PRIMARY MURINE B CELLS FOR THE ESTABLISHMENT OF A SYNTHETIC IMMUNITY IN VIVO USING CRISPR/CAS9...... 181 R.A. Ehling, W. Kelton, B. Wagner, T. Pesch, S.T. Reddy A ONE-STOP SHOP FOR EVERYTHING GENE TO PROTEIN: COMBINE HIGHLY ADVANCED EXPRESSION SYSTEMS WITH EXPRESSION OPTIMIZED GENES ...... 182 S. Fath, L. Ludewig, M. Liss, C.Y. Liu, K. Thompson, S. Barnes, M. Yovcheva, J. Zmuda, M. Graf

EXOSOME EVALUATION BASED ON SURFACE PLASMON RESONANCE IMAGING (SPRI) AND PARTICLE SIZE ANALYSIS ...... 183 C. Frydman, D. Irikura, H. Nakayama

UTILITY OF HUMAN FCRN TRANSGENIC MICE FOR PRECLINICAL SCREENING OF IMMUNOTHERAPEUTICS...... 184 R. Gareus, G. Christianson, E. Lowell, E. Rocker, J. Newell, E. Fox, C. Lutz

HEMIBODIES: NOVEL COMPLEMENTING T-CELL ACTIVATING ANTIBODY DERIVATIVES FOR SAFE CANCER IMMUNOTHERAPY ...... 185 M. Geis, B. Nowotny, H. Einsele, G. Stuhler, T. Bumm

PROTEIN FORMULATION SCREENING FOR THE PIPPI DATABASE ...... 186 L. Gentiluomo, L. Gentiluomo, W. Friess, D. Roessner, D. Augustijn, A. Rinnan, A. Tosstorff, H. Svilenov, I. El Bialy, G. Winter, C.A. Pohl, S. Mahapatra, W. Streicher, A. Norgaard, M. Morales, M. Greco, C.V.D. Walle, S. Uddin, A. Roche, R. Curtis, T.A. Khan, A. Kulakova, S. Indrakumar, G.H.J. Peters, P. Harris

IMPROVED STABILITY AND HIGHER YIELD OF BIOPHARMACEUTICALS DURING MANUFACTURING BY THE AMINO ACID-BASED TECHNOLOGY PLATFORM SPS® ...... 188 S. Hauck, K. Kemter, J. Altrichter, E. Reinauer

DEVELOPING AN INTEGRATED SUMMARY OF IMMUNOGENICITY (ISI) TO EFFECTIVELY MANAGE REGULATORY RISKS IN PRODUCT DEVELOPMENT ...... 189 J.B. Holz, P. Chamberlain

THE GENERATION OF HALF-LIFE EXTENDED AFFIMER BIOTHERAPEUTICS THAT ANTAGONIST HUMAN PD-L1 ...... 190 E. Jenkins

QUANTITATIVE APPROACH TO PROTEIN AGGREGATION STUDY: METHODS LIMITATIONS, PITFALLS AND IMPORTANCE OF AGGREGATION MECHANISM UNDERSTANDING ...... 191 D.A. Kara, V.A. Borzova, K.A. Markossian, B.I. Kurganov

OVERCOMING LIMITATIONS OF CONVENTIONAL TAG SYSTEMS - STREP- TACTIN®XT APPLICATIONS ...... 193 D. Karthaus, U. Carl, L. Batz, S. Kramer, F. Mueller, S. Koenig, T. Schmidt

NOVEL ANTIBODY ENGINEERING TO ENHANCE DUAL-ANTIGEN TARGETING SPECIFICITY ...... 194 T. Kawa, Y. Noguchi, H. Katada, H. Segawa, H. Shiraiwa, T. Kitazawa, T. Igawa

C-TAG AFFINITY TAG: FROM ROUTINE PROTEIN PURIFICATION TO USE IN A CGMP PRODUCTION PROCESS ...... 195 E. Klijs, F. Detmers, P. Hermans, K. Sleijpen, R. Clasen, J. de Rooij

ADVANCED FORMULATIONS OF BIOPHARMACEUTICALS ...... 196 J. Koehn, J. Altrichter, B. Schwab, K. Petropoulos, S. Hauck

FORCED CONVECTION EVAPORATION FOR BULK PROTEIN CRYSTALLIZATION ...... 197 M. Kolodziej, M. Olbrycht, I. Poplewska, W. Piatkowski, D. Antos BIOCHEMICAL AND FUNCTIONAL CHARACTERIZATION OF NOVEL COMPLEMENTARY CD3-SPECIFIC ANTIBODIES TERMED HEMIBODIES ...... 198 D. Kouhestani, J. Heiby, P. Eiring, T. Schnyder, T. Bumm, H. Neuweiler, M. Sauer, G. Stuhler, H. Einsele

HORIZON - HIGH THROUGHPUT LOW VOLUME SUBVISIBLE PARTICLE ANALYSIS ...... 199 D. Lund, C. Ashcroft, T. Castner, B. DiPaolo, G. Konica, T. Geise, X. Li, C. Wood, B. Cordovez

COMBINING ULTRASOUND-MEDIATED CAVITATION AND BIOCOMPATIBLE CONJUGATION CHEMISTRY TO IMPROVE ONCOLYTIC VIRUS DELIVERY ...... 200 B. Lyons, M. Grundy, K. Fisher, R. Carlisle, C. Coussious

SPECIFIC TARGETING LYMPHOMA USING SEMISYNTHETIC ANTI-IDIOTYPE SHARK ANTIBODIES ...... 201 A.M. Palacion, J. Grzeschik, T. Pirzer, D. Konning, S. Krah, S. Zielonka, H. Kolmar

STRUCTURE STUDIES ON THE CARBOHYDRATE TRANSPORTERS, ENZYMES II, OF THE PHOSPHOENOLPYRUVATE-DEPENDENT PHOSPHOTRANSFERASE SYSTEM FROM STREPTOCOCCUS PNEUMONIAE ...... 203 M. Magoch, P. Nogly, P. Grudnik, P. Ma, B. Szelazek, M. Archer, G. Dubin

BIOLOGICAL CHARACTERIZATION OF A NOVEL OCTREOTIDE CONJUGATE FOR TARGETED DRUG DELIVERY ...... 205 A. Martins, E. Figueras, A. Borbely, V. Le Joncour, P. Lakkonen, D. Modena, N. Sewald, P. Gallinari, C. Steinkuhler

IN VIVO PHAGE DISPLAY SELECTIONS FOR DEVELOPMENT OF NOVEL BLOOD BRAIN BARRIER CROSSING SINGLE DOMAIN ANTIBODIES ...... 206 S. Aguiar, A. Andre, V. Neves, J. Dias, B. Carrapico, L. Gano, J. Galamba, R. Nobre, L. Almeida, L. Tavares, M. Castanho, J. Goncalves, F. Aires-da-Silva

TUMBLER: ANTIBODY ENGINEERING CAN GENERATE BILLIONS OF ANTIBODY VARIANTS WITH THERAPEUTIC PROPERTIES ...... 208 D. Maurer, S. Youssef, S. Ives, C. Pettus, R. Newland, V. Chou, K. Hervold, C. Smith, G. Day, C. Jones, S. Daraeikia, A. Sancez, J. Brysting, J. Glanville

NEBULIZATION OF MONOCLONAL ANTIBODIES: IMPACT OF THE FORMULATION ...... 209 A. Mayor, B. Thibert, R. Respaud, S. Huille, H. Audat, N. Heuze-Vourc'h

QUANTITATIVE CELL-BASED BIOASSAYS TO ADVANCE IMMUNOTHERAPY PROGRAMS TARGETING IMMUNE CHECKPOINT RECEPTORS ...... 210 R. Nagy, J. Grailer, J. Gilden, P. Stecha, D. Garvin, J. Wang, M. Beck, J. Hartnett, F. Fan, M. Cong, Z.J. Cheng

INTENSIFICATION OF MAB DOWNSTREAM PROCESSES USING MODULAR INNOVATIVE PURIFICATION TECHNOLOGIES ...... 211 G. Neumann, A. Trapp, V. Kossler, A. Faude, S. Schubert

BIOPHARMAVIEW™ FOR FAST AND EFFICIENT MONITORING OF PH INDUCED DEAMIDATION ...... 212 H.M. Nicar, K. Pohl, L. Ji, S. Heidelberger, A. Uppal

MULTI-ATTRIBUTE MONITORING (MAM) TO IDENTIFY DIFFERENCES IN TRASTUZUMAB FROM TWO MANUFACTURERS ...... 214 H.M. Nicar, K. Pohl, S. Heidelberger COMPLETELY AUTOMATED PLASMID PREP AND OPTIMIZED PROTEIN SEPARATION USING PHYTIP COLUMNS ...... 215 S. Nimri, C. Huynh, L. Hoang, C. Suh, D. Gjerde

PRODUCTION AND FUNCTIONAL CHARACTERIZATION OF BISPECIFICS AND OTHER NOVEL ANTIBODY DERIVATIVES USING SCALABLE NON-VIRAL CELL ENGINEERING ...... 216 G. Nobels, W. Wang, R. Shivakumar, P. Natarajan, K. Steger, J. Brady

MEASUREMENT OF FC-MEDIATED ADCC AND CDC ACTIVITY OF ANTI-TNFA AND ANTI-VEGF THERAPEUTIC ANTIBODIES USING REPORTER-BASED BIOASSAYS AND ENGINEERED TNFA+ AND VEGF+ TARGET CELLS ...... 217 V. Ott, D. Garvin, J. Grailer, R. Moravec, J. Hartnett, F. Fan, M. Cong, Z.J. Cheng

CHARACTERIZING, DIFFERENTIATING AND COUNTING SUB-VISIBLE PROTEIN AGGREGATES WITH HOLOGRAPHIC VIDEO MICROSCOPY ...... 218 L.A. Philips, P. Kasimbeg, F.C. Cheong, D.B. Ruffner, J.M. Blusewicz

PREDICTING TOOL FOR DESIGN AND SCALING UP PROTEIN CHROMATOGRAPHY ...... 219 W. Piatkowski, W.K. Marek, D. Sauer, A. Durauer, A. Jungbauer, D. Antos

CHARACTERIZATION OF INTACT MONOCLONAL ANTIBODIES UNDER NATIVE AND REVERSE PHASE CONDITIONS USING HIGH RESOLUTION MASS SPECTROMETRY ...... 220 K. Pohl, R. Yokoyama, S. Heidelberger, A. Uppal

MONITORING OF SEQUENCE VARIANTS BY MAM USING HIGH RESOLUTION MASS SPECTROMETRY ...... 221 K. Pohl, Y. Li, A. Uppal, S. Heidelberger

A MODIFIED SMALL-ANGLE X-RAY SCATTERING TECHNIQUE FOR DETERMINING KINETICS OF BULK PROTEIN CRYSTALLIZATION ...... 222 I. Poplewska, A. Lyskowski, M. Kolodziej, P. Szalanski, W. Piatkowski, D. Antos

RAPID PURIFICATION AND CHARACTERIZATION OF RECOMBINANT PROTEINS AND ANTIBODIES: CAPTUREM HIGH CAPACITY MEMBRANES ...... 223 M. Raman, G. Jokhadze, C. Hoppmann, M. Vierra, B. Levitan, M. Li, T. Larson, A. Farmer

SOLVING TARGET PROTEIN PRODUCTION CHALLENGES ...... 225 S. Reich, J. Reid, W. Savory, A. Jones, D. Hothersall, K. Chapman, T. Perrior

DEVELOPMENT OF AN IGG BASED, BISPECIFIC ANTIBODY WITH FLT3XCD3- SPECIFICITY FOR THE TREATMENT OF MYELOID LEUKEMIA ...... 226 H.R. Salih, M.S. Pfluegler, F. Vogt, I. Ehnes, H.J. Buhring, G. Jung

DECREASING DMSO CONTENT ON CRYOPRESERVATION OF STEM CELLS - THE IMPORTANCE OF DIRECTIONAL HEAT TRANSFER IN ICE GROWTH GEOMETRY ...... 227 P.S. Rego, M. Costa, C. Lobato, F. Ferreira, V. Deraldes, M.A. Rodrigues

EVALUATION OF BACKGROUNDED MEMBRANE IMAGING (BMI) FOR ITS APPLICATION IN THE HIGH-THROUGHPUT ANALYSIS OF SUBVISIBLE PARTICLES ...... 228 R. Tantipolphan, C. Helbig, G. Ammann, W. Friess, K. Wuchner, A. Hawe

COMBINATORIAL THERAPY WITH MABS AND NINTEDANIB ENHANCES CANCER CELL LETHALITY ...... 230 W.C.J. Teo, W.C.J. Teo, H.L. Tan, R.Y.J. Huang, A.B.H. Choo MULTIDROSI - A NEW TOOL FOR MULTIGENE APPLICATIONS IN S2 INSECT CELLS ...... 231 R. Thoma, D. Schlatter, D. Brugger, D. Hugin, M. Fogetta, M. Siegrist, T. Bulau, C. Miscenic, I. Berger

MULTIFUNCTIONAL HUMABODY® BIOLOGICS FOR IMMUNE-ONCOLOGY BASED ON IN VIVO MATURED FULLY HUMAN VH DOMAINS ...... 232 H.L. Thompson, G. Benedetti, A. Sette, L. Eghobamien, C. Edwards, B. Revi, M. Lewandowska, Y. Teng, C. Johnston, D. Sydoruk, E. De Juan, E. Hames, S. Archer, J. Majithiya, P. Hayes, S. Vance, C. Wyre, C. Wilson, J. Craigen, J. Arizanova, N. Birkett, N. Royle, S. Fiaska, W. Wang, B. Di Fiore, Y. Surani, C. Enever, S. Stelter, D. Granger, J. Legg, P. Bland-Ward, P. Pack

THE NOVEL SYSTEM FOR QUANTIFICATION OF AGGREGATED ANTIBODIES ...... 233 T. Toyoshima, K. Iijima, K. Furukawa, K. Katayama, N. Jin, M. Seki

HIGH THROUGHPUT DOWNSTREAM PROCESSING USING CELLULOSE FIBRE TECHNOLOGY AND ÄKTAT CHROMATOGRAPHY SYSTEMS ...... 234 L. Troeng

EFFECTS OF PRODUCT HANDLING PARAMETERS ON PARTICLE LEVELS IN A COMMERCIAL FACTOR VIII PRODUCT: IMPACTS AND MITIGATION ...... 235 T. Ueda, K. Nakamura, Y. Abe, J.F. Carpenter

EXCIPIENT EFFECTS ON BIOPHARMACEUTICAL ASSOCIATION AND AGGREGATION UNDER CHEMICALLY DENATURING CONDITIONS ...... 236 N. Vekaria, R. Curtis, J. Warwicker

PURIFICATION OF LARGE BIOMOLECULES WITH TAILORED ANION EXCHANGERS ...... 237 C. Voss

LOW PH INCUBATION OF THERAPEUTIC ANTIBODIES FOR VIRAL INACTIVATION INDUCES CONFORMATIONAL CHANGES, SUBSEQUENT NEUTRALIZATION LEADS TO AGGREGATION ...... 238 R. Waelchli, M.M.S. Ressurreicao, F. Feidl, S. Vogg, M. Morbidelli

TARGETING NANOMATERIAL TO PROSTATE SPECIFIC MEMBRANE ANTIGEN USING A BISPECIFIC ANTIBODY FOR PROSTATE CANCER THERANOSTIC APPLICATIONS ...... 240 A. Wardiana, M.L. Jones, S.M. Mahler, K.J. Thurecht, C.B. Howard

FUNCTIONAL MATURATION OF BLOOD-BRAIN BARRIER PENETRATING VNAR ...... 241 K.B. Wicher, P. Stocki, J. Szary, D. Logan, M. Demydchuk, L. Northall, J.L. Rutkowski

SUPERHUMAN 2.0: COMPUTATIONALLY OPTIMIZED LIBRARY DESIGN WITH SUPERIOR SCAFFOLDS AND DIVERSITY ...... 242 D. Maurer, S. Ives, C. Pettus, R. Newland, V. Chou, K. Hervold, C. Smith, G. Day, C. Jones, S. Daraeikia, A. Sanchez, J. Brysting, J. Glanville

INTERFIBRIL INTERACTION OF AMYLOID FIBRILS BASED ON AFM STUDIES ...... 243 J. Zhou, S. Sekatskii, G. Dietler

MICROFLUIDIC MODULATION SPECTROSCOPY ANALYSIS OF A MONOCLONAL ANTIBODY AT DIFFERENT CONCENTRATIONS ...... 244 J. Zonderman, L. Wang, I.A. Papayannopoulos, S. Renn-Bingham

Author Index