MARCH 31 - APRIL 2, 2015€¦ · chemistries, while developing strategies for homogeneity engineering and biophysical characterization of ADCs. Track 2: Phage & Yeast Display 噬菌体和酵母展示

1 | PEGSummitChina.com

MARCH 31 - APRIL 2, 2015

SHANGHAI MARRIOTT HOTEL PUDONG EASTSHANGHAI, CHINA

PEGSummitChina.com

2015 CONFERENCE PROGRAMS:

Protein & Antibody Engineering

Phage & Yeast Display

Antibody-Drug Conjugates

Characterization of Biotherapeutics

The Definitive Meeting Place for Protein & Antibody Scientists from Around the World:

* Abbott * Abbvie * Agensys * Albert Einstein College * Amgen * Chugai * City of Hope * Dartmouth College * F-Star Biotechnology * Fudan University * Garvan Institute * Genentech * Heidelberg Pharma * Henlius * IMCB Singapore * Kadmon * Livzon MabPharm * Mabspace * MacroGenics * MD Anderson Cancer Center * MedImmune * Merrimack * NIABC * NIH * NewBio Therapeutics * Northwest A&F University * Pfizer * PharmAbcine * Pieris * Rinat * Roche Diagnostics * Sanofi * Shanghai C P Guojian * Sutro BIopharma * University of Toronto * University of Queensland * University of Zurich * USP China * Zova Biotherapeutics

FINAL AGENDA

PEGSCHINACAMBRIDGE HEALTHTECH INSTITUTE’S 2ND ANNUAL

Protein & Antibody Engineering and Development Summit

第二届中国

蛋白与抗体工程及研发峰会

REGISTER BY FEBRUARY 27

& SAVE UP TO $200

Organized by Cambridge Healthtech Institute

Premier Sponsor

蛋白质与抗体工程

噬菌体和酵母展示

抗体及药物结合物

生物制药分析表征

PEGS China: the quintessential protein and antibody engineering and development summit in China

Building on its inaugural success and back with new and expanded tracks, CHI’s 2nd Annual PEGS China selects and presents key trends, latest case studies and leading players in the worldwide biopharmaceutical industry who are pushing the envelope in protein and antibody engineering. The Summit will provide you with the scientific knowledge and technical know-how that will help advance your biologics to the next phase of development, be they ADCs, bispecifics, novel proteins, antibody constructs or biosimilars.

This 3-day event is THE meeting place for international and China scientists to come face-to-face and share case studies and project updates, explore new techniques, hear innovative ideas, and form new collaborations or solidify existing partnerships.

Meet and hear from our distinguished international Speaker Faculty including these Keynotes & Featured Speakers:

Track 1: Protein & Antibody Engineering 蛋白质与抗体工程Explore techniques to enhance antibody binding and specificity, and delve into strategies for design and development of novel scaffolds and next generation bispecific antibodies.

Track 3: Antibody-Drug Conjugates 抗体及药物结合物Examine novel payloads, linker technologies and conjugation chemistries, while developing strategies for homogeneity engineering and biophysical characterization of ADCs.

Track 2: Phage & Yeast Display 噬菌体和酵母展示Learn novel discovery and screening strategies to generate antibodies against challenging targets and discover antibodies with optimized efficacy and improved properties.

Track 4: Characterization of Biotherapeutics 生物制药分析表征Appraise different technologies and methods for characterizing novel formats and improving the stability and solubility of biologics and biosimilars.

PEGSCHINACambridge Healthtech Institute’s 2nd Annual

Protein & Antibody Engineering and Development Summit

第二届中国

蛋白与抗体工程及研发峰会

Antibody Development Strategies in Today’s ChinaChengbin Wu, Ph.D., President of R&D and CSO, Shanghai C P Guojian Pharmaceutical Co., Ltd., PR China

Designing and Engineering Novel Bispecific/Bifunctional Antibodies and Fusion Proteins for Enhanced Antitumor ActivityZhenping Zhu, Ph.D., Executive Vice President, Global Biopharmaceuticals, Kadmon Corporation

Whose Problem Is Post-Translational Modifications? Discovery, Cell Culture, Chromatography or Formulation?Chandrashekar Ganesa, Ph.D., Senior Director, Analytical Development, Global Biotherapeutics, Sanofi

Kinetic and Thermodynamic Landscape of Protein AggregationBilikallahalli Muralidhara, Ph.D., Associate Director, Vaccines & Biologics, Biopharmaceutical Development, MedImmune, Inc.

ADCs: Is It Time to Rethink Some Preconceptions?Shu-Hui Liu, Ph.D., Assoc Research Fellow, Department of Biology, Rinat-Pfizer

Current Clinical Experience with Antibody-Drug Conjugates: A View through the Therapeutic WindowRobb Kahn, M.D., Senior Safety Science Leader, Global Pediatric Oncology Drug Development, Genentech, a member of the Roche Group


CONFERENCE AT A GLANCE

RESEARCH POSTER SUBMISSION

Cambridge Healthtech Institute encourages attendees to gain further exposure by presenting their work in the poster sessions. To secure a poster board and inclusion in the conference materials, your abstract must be submitted, approved and your registration paid in full by February 27, 2015.

Reasons you should present your research poster at this conference:

• Your poster will be showcased to our international delegation

• Receive $50/ ¥200 off your registration

• Your poster abstract will be published in our conference materials

• Your research will be seen by leaders from top pharmaceutical, biotech, academic and government institutes

Group Discounts: Register 3 and 4th is FREE.Discount applies to attendees from the same organization registering for the same event. All registrations must be submitted together to qualify for the discount.

Alumni Discount - 20% offCambridge Healthtech Institute (CHI) appreciates your participation at our events. As a result of the great loyalty you have shown us, we are pleased to extend to you the exclusive opportunity to save an additional 20% off the registration rate. Just check off the box marked Alumni Discount on the registration form to receive the discount. Please note: Our records must indicate you were an attendee at a past CHI event in order to qualify.

JOIN THE PEGS COMMUNITY ONLINE

Premier Sponsor

Corporate Sponsors

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TUESDAY, MARCH 31 Track 1:Protein & Antibody Engineering

Track 2:Phage & Yeast Display

Plenary Keynotes

WEDNESDAY, APRIL 1 (morning)

Track 1:Protein & Antibody Engineering

Track 2:Phage & Yeast Display

WEDNESDAY, APRIL 1 (afternoon)

Track 3:Antibody-Drug Conjugates

Track 4:Characterization of Biotherapeutics

Plenary Keynotes

THURSDAY, APRIL 2 Track 3:Antibody-Drug Conjugates

Track 4:Characterization of Biotherapeutics

Joint Closing Session



TRACK 1: PROTEIN & ANTIBODY ENGINEERINGInnovative Engineering * Novel Scaffolds * Bispecific Antibodies

TRACK 2: PHAGE & YEAST DISPLAYNovel Screening * Improved Properties * Challenging Targets


7:30 am Registration and Morning Coffee8:50 Chairperson’s Opening RemarksDimiter Dimitrov, Ph.D., Senior Investigator, NCI, National Institutes of Health

ENHANCING ANTIBODY BINDING, SPECIFICITY AND DRUG-LIKE PROPERTIES

UnpublishedData

Case Study

9:00 Antibody Engineering for Better in vivo EfficacyWeidong Jiang, Ph.D., CSO, Henlius Biopharmaceuticals, Inc.Antibody engineering is a great tool for improving antibody functions in vivo. We have routinely engineered therapeutic antibodies for better in vivo efficacies via affinity maturation, specifically by improving on-rate of the antibody binding affinities. One particular case will be reported here for better functions in vivo as well as other functions such as immunogenicity improvement.

UnpublishedData

9:30 In vitro and in vivo Study of pH-Dependent Antigen Binding Antibody with Increased FcgammaRIIB BindingYuji Hori, Ph.D., Research Scientist, Chugai Pharmaceutical, JapanSweeping antibody with enhanced FcR mediated cellular uptake of antibody-antigen complex and pH-dependent endosomal antigen dissociation enables antigen elimination from plasma, providing enhanced efficacy and novel mode of action for antibody therapeutics. This talk will present an in vivo profile of sweeping antibody and its in vitro confocal microscopic study to address the intracellular trafficking of the soluble antigen.

10:00 Design and Develop Next-Generation Bispecific Antibodies with Good Drug Like Properties (DLP)Jinming Gu, Ph.D., Senior Scientist, Global Biologics, Abbvie, Inc.Bispecific antibodies have emerged as the next generation of antibody-based therapeutics. So far, there have been more than 50 different bispecific antibody platforms published in the literature. However, it continues to be a major challenge to identify bispecific antibodies with good drug like properties which functions preclinically. This presentation will discuss different approaches we are utilizing to design and develop bispecific antibodies with good drug like properties.

10:30 Coffee Break

NOVEL PROTEINS AND ALTERNATIVE SCAFFOLDS

UnpublishedData

11:00 Anticalins: Versatile Binding Proteins based on a Flexible Natural ScaffoldArne Skerra, Ph.D., Professor, Technische Universität München; Founder, Pieris AG, GermanyAnticalins are derived from human lipocalins, whose four structurally hypervariable loops form a binding site that can be tailored against medically relevant targets. However, anticalins are much smaller and comprise a single polypeptide chain, offering facile production in microbial hosts and flexible formatting: multiple specificities, attachment of payloads and extended plasma half-life via PEGylation or PASylation. Two anticalins have reached clinical stage for therapeutic applications.

11:30 ADAPT - A Novel Scaffold Protein for Radionuclide Molecular ImagingJohan Nilvebrant, Ph.D., Postdoctoral Researcher, The Donnelly Centre, Center for Cellular and Biomolecular Research, University of Toronto, CanadaADAPTs (ABD-derived affinity proteins) are a novel class of scaffold-based affinity proteins, which are derived from the albumin-binding domain (ABD) of streptococcal protein G. They have been generated in a bispecific format to target various antigens. These radiolabeled ADAPTs were recently used to provide high contrast PET-images of HER2 positive tumor xenografts shortly after injection and show promise as a new class of imaging agents.

12:00 pm Sponsored Presentation (Opportunity Available)12:30 Networking Luncheon

7:30 am Registration and Morning Coffee8:50 Chairperson’s Opening RemarksJonas V. Schaefer, Ph.D., Head, High-Throughput Laboratory, Department of Biochemistry, University of Zurich, Switzerland

NOVEL DISCOVERY AND SCREENING STRATEGIES9:00 Novel Fully Human Antibody Development Towards Immune Regulators Yan Luan, Ph.D., Director, DingFu Biotarget Co.Novel fully human antibodies targeting immune checkpoints were developed by yeast display systems. My presentation will includes a platform introduction as well as Case study about PD-L1 antagonist Ab development. Both biology and developability are considered and evaluated.

Case Study

9:30 Drug Discovery Using a Modular Antibody Platform™Haijun Sun, Ph.D., Vice President, Tumor Biology and Protein Sciences, F-Star Biotechnology, United KingdomIn this presentation, we will discuss our Modular Antibody Platform and highlight some of the key steps during the discovery phase to select the best monospecific or bispecific therapeutic candidates. Several case studies from preclinical programs will be discussed.

10:00 Establishment of an Innovative High-Throughput Platform for Next-Generation Binder DiscoveryJonas V. Schaefer, Ph.D., Head, High-Throughput Laboratory, Department of Biochemistry, University of Zurich, SwitzerlandTo optimize the efficiency and capacity of next-generation binder selections and discovery, our laboratory established a streamlined process, consisting of parallel Ribosome Display selections and various semi-automated high-throughput screenings. We now can perform simultaneous selections against 94 targets and subsequently screen and validate several thousand binders in parallel for their binding and biophysical characteristics. This results in the need of testing fewer candidates to eventually find the most promising lead candidates.

10:30 Coffee Break

ANTIBODIES AGAINST COMPLEX & CHALLENGING TARGETS

11:00 Strategy for Identifying Allosteric Antibody that Modulates Membrane ReceptorMichelle Yuqing Shen, Ph.D., Senior Scientist, Amgen China R&DWe developed a screening strategy using in vitro cell-based assays to identify antibodies that enhanced endogenous ligand signaling. Furthermore, we applied binding assays to reveal those antibodies that do not compete with endogenous ligand binding to receptors. This mechanism of action leverages on enhancement of endogenous ligand signaling while offers greater receptor selectivity and better safety profile owing to allosteric binding to receptors and modulators’ ceiling effect.

11:30 Generation and Optimization of Nanoparticle Targeting AntibodiesLihui Xu, Associate Director and Antibody Technology Team Leader, Merrimack Pharmaceuticals

12:00 pm Sponsored Presentation (Opportunity Available)12:30 Networking Luncheon

PEGS CHINA | TUESDAY, MARCH 31




1:45 Chairperson’s RemarksJonas V. Schaefer, Ph.D., Head, High-Throughput Laboratory, Department of Biochemistry, University of Zurich, Switzerland

ANTIBODIES AGAINST INFECTIOUS DISEASES1:50 Synthetic Antibodies for Ebola Virus Immunotherapy and ResearchJonathan R. Lai, Ph.D., Associate Professor, Biochemistry, Albert Einstein College of MedicineSynthetic antibody engineering is an emerging technology for the identification of highly specific antibodies from large molecular display libraries. Here, we will show the application of this method to discover potential immunotherapies and research reagents for Ebola virus. We have identified novel synthetic antibodies against the glycoproteins of the Zaire (EBOV) and Sudan (SUDV) Ebolavirus species. These antibodies have neutralization potential and, in the case of SUDV, afford post-exposure protection of mice.

2:20 Novel Strategies for Isolation of Antibodies Against Infectious Disease TargetsStephen Mahler, Ph.D., Professor, Australian Institute for Bioengineering and Nanotechnology, University of Queensland, AustraliaUsing either immunised or naïve libraries and phage display technology, we demonstrate novel strategies for isolation of antibodies that bind immunodominant and non-immunodominant epitopes of viral antigens. The strategies include biopanning against recombinant viral antigens, peptides, antigens expressed on host cell surface and also the use of molecular scaffolds to display viral protein domains. Strategies for isolation of novel antibodies that bind Dengue and Malaria antigens are presented.

2:50 The Development of Antibody-Based Therapeutics for the Treatment of Emerging Infectious DiseasesTianlei Ying, Ph.D., Head, Antibody Engineering and Drug Discovery Group, School of Basic Medical Science, Fudan UniversityEmerging infectious diseases are currently the major threat to public health. By using human antibody libraries and in vitro display technologies we have identified potent neutralizing antibodies against some new viruses including MERS-CoV and avian influenza viruses. We also have been working on the engineering of novel antibody fragments with small size and long in vivo half-lives.

3:20 Sponsored Presentation (Opportunity Available)3:50 Refreshment Break

5:40 Welcome Reception in the Exhibit Hall with Poster Viewing6:40 Close of Day

1:45 Chairperson’s RemarksDimiter Dimitrov, Ph.D., Senior Investigator, NCI, National Institutes of Health

NOVEL PROTEINS AND ALTERNATIVE SCAFFOLDS (cont’d)1:50 Exceptionally Potent and Broad Inhibitors of HIV-1 based on Antibody Domains and One Domain Soluble CD4 Multivalent Fusion ProteinsDimiter Dimitrov, Ph.D., Senior Investigator, NCI, National Institutes of HealthWe generated bispecific multivalent fusion proteins of an engineered cavity-altered single-domain CD4 with another potent HIV-1 inhibitor - an antibody domain targeting the coreceptor-binding site on gp120. The fusion proteins neutralized all HIV-1 isolates tested with potency about 10-, 50-, and 200-fold higher than that of VRC01, T20, and sCD4-Fc fusion protein CD4-Ig, respectively. These fusion proteins could be potentially useful for HIV-1 therapy including eradication of the virus.

2:20 Cross-Neutralizing Single-Domain Antibodies to Pandemic InfluenzaSimon E. Hufton, Ph.D., Principal Scientist, Biotherapeutics, National Institute for Biological Standards and Control (NIBSC)The response to the 2009 A(H1N1) influenza pandemic has highlighted the need for additional strategies for intervention which preclude the prior availability of the influenza strain. We have isolated single domain antibodies with broad neutralisation activity from immunised alpaca’s and used yeast display technology to investigate antibody/antigen interactions to assist in the understanding of their mechanism of action. These single domain antibodies are attractive candidates for diagnostics and immunotherapy of pandemic influenza.

UnpublishedData

2:50 Meditopes: Development of Noncovalent Peptide-Fab Interaction to Rapidly and Specifically Add Functionality to mAbsJohn C. Williams, Ph.D., Associate Professor, Molecular Medicine, Beckman Research Institute at City of HopeMAbs require chemical conjugation and/or extensive re-engineering to deliver toxins, imaging agents and other functionalities to diseased tissues. Herein, we present the discovery of a novel cyclic peptide (aka a meditope) that binds to the cavity of cetuximab Fab. While this binding site is unique to cetuximab, it can be grafted on to mAbs. Studies will be presented highlighting the rapid and efficient functionalization of mAbs.


5:40 Welcome Reception in the Exhibit Hall with Poster Viewing6:40 Close of Day

4:35 Keynote IntroductionsWeidong Jiang, Ph.D., CSO, Henlius Biopharmaceuticals, Inc.

UnpublishedData

Case Study

4:40 Antibody Development Strategies in Today’s ChinaChengbin Wu, Ph.D., President, R&D and CSO, Shanghai C.P. Guojian Pharamceutical Co. Ltd., PR ChinaIn the past 10 years, commercial manufacturing of antibodies at GMP standard has become possible in China, leading to successful commercialization of several antibody-based therapeutics, with many more in various stages of development.

This talk will provide a brief overview of antibody development in China, with a case study discussing key aspects of developing an anti-Her2 antibody that has completed Phase III clinical trials in China.

5:10 Designing and Engineering Novel Bispecific/Bifunctional Antibodies and Fusion Proteins for Enhanced Antitumor ActivityZhenping Zhu, Ph.D., Executive Vice President, Global Biopharmaceuticals, Kadmon CorporationMajor obstacles in the successful development of BsAb (bispecific antibodies) have been the difficulties of designing and constructing a druggable molecule and producing sufficient materials for development and commercialization. The technological

challenge is to construct a recombinant molecule with good pharmaceutical properties. Developing highly effective BsAb and bifunctional proteins will require clear elucidation and understanding of the molecular details in the aberrant signaling pathways that lead to various diseases to guide the selection of the target pairs for co-targeting.

PLENARY KEYNOTE SESSION

PEGS CHINA | TUESDAY, MARCH 31




8:30 am Registration and Morning Coffee8:50 Chairperson’s Opening RemarksDaniel Christ, Ph.D., Associate Professor & Head, Antibody Therapeutics, Immunology Program, Garvan institute of Medical Research, Australia

GENERATING ANTIBODIES AND COMPLEX PROTEINS WITH IMPROVED PROPERTIES

9:00 Stable Human Antibody Therapeutics and Biobetters through Engineering of Complementarity Determining RegionsDaniel Christ, Ph.D., Associate Professor & Head, Antibody Therapeutics, Immunology Program, Garvan institute of Medical Research, AustraliaWe have recently identified aggregation hotspots in the CDR regions of antibody variable domains, and have developed generally applicable phage display strategies to overcome these limitations. Here we outline the application of the technology to human IgG antibody therapeutics, and present examples of how the approach can be utilised for the ‘retrofitting’ of preclinical and clinical candidate molecules, as well as biobetters.

9:30 Identification of Myeloid-Derived Suppressor Cell-Specific Targets by Phage DisplayHong Qin, M.D., Ph.D., Assistant Professor, Lymphoma & Myeloma, MD Anderson Cancer CenterWe identified two novel, mouse MDSC-specific peptides using phage display technology. The engineered peptides (peptibodies) efficiently depleted systemic and intratumoral MDSC in tumor-bearing mice, but did not affect other proinflammatory cell types. Proteomic analysis of cell surface membrane proteins precipitated by the peptibodies suggests that the lead candidate target on the surface of MDSC is S100 family proteins (S100A9/A8). Hence, we developed a technical platform of cell-specific marker discovery.

10:00 Sponsored Presentation (Opportunity Available)

10:30 Coffee Break in the Exhibit Hall with Poster Viewing

Case Study

11:10 Affinity Matured Anti-Tacrolimus Antibody for Improved Immunoassay PerformanceBailin Tu, Ph.D., Principal Scientist, Biologics Discovery and Design, Abbott LaboratoriesWe screened and isolated scFv clones from diverse libraries with mutagenic complementarity regions (CDRs) from anti-tacrolimus hybridoma cell line using yeast display. Various combinatorial pairings constructed from these individual mutations contained >10-fold improvements in both the dissociation rate and overall equilibrium affinity constants. Selected clones produced as IgG have increased functional sensitivity, with a 3- to 6-fold better performance relative to the parental tacrolimus monoclonal antibody.

UnpublishedData

Case Study

11:40 Employing Immune Tolerance Technology to Obtain Antibodies with Improved PK/PD PropertiesXueming Qian, Ph.D., Chairman and CEO, Mabspace Biosciences, Co. Ltd., PR ChinaGenerating antibodies with improved PK/PD properties is an important goal for developing a differentiated and competitive antibody product. We employ immune tolerance breaking technology to obtain antibodies targeting diverse epitope space, enabling the selection of antibodies with improved biological activities, improved manufacturability or pH-dependent binding to enable recycling. Case studies will be presented for fast follow-on antibody programs targeting PDL-1 and VEGFR2, two important proteins regulating tumor microenvironment.

UnpublishedData

12:10 pm Igy Antibody Engineering, More Than Antibody Extraction from Egg YolkXiaoYing Zhang, Ph.D., Professor, Veterinary Pharmacology, College of Veterinary Medicine, Northwest A&F UniversityAvian IgY antibodies have been generated against conserved mammalian antigens with high titer and specificity, and also successfully developed to detect small molecules in nano-molar range/mL. mIgY antibodies can be effectively used in certain applications like immunological detection and diagnosis, screening and validating biomarkers, and drug targets. mIgY antibodies are developed by phage display technology. And these can be developed into Ab fragments, chimeric Abs and humanized Abs.

12:40 Networking Luncheon in the Exhibit Hall with Poster Viewing and Close of Phage & Yeast Display Conference

8:30 am Registration and Morning Coffee8:50 Chairperson’s Opening RemarksStephen Mahler, Ph.D., Professor, Australian Institute for Bioengineering and Nanotechnology, University of Queensland

NOVEL APPLICATIONS FOR BISPECIFIC ANTIBODIES9:00 Therapeutic Applications of DART Proteins – What’s Next?Jonathan Li, Ph.D., Scientist II, MacroGenics, Inc.Bispecific antibodies that recruit effector cells to tumors represent a highly potent class of immunotherapeutic agents that may outperform or complement traditional chemotherapy, naked antibodies and ADCs. MacroGenics’ Dual-Affinity Re-Targeting (DART) proteins are among the most stable and potent biologics in this therapeutic class. This talk will highlight several DART proteins currently in clinical studies and those entering clinical studies, as well as new formats and specificities that are under development for future drug candidates.

UnpublishedData

9:30 Antibody Engineering Strategies for the Production of Bispecific Heterodimeric IgG in Mammalian CellsWei Yan, Ph.D., Director, Research, Therapeutic Discovery, Amgen, Inc.



11:10 Clinical Development of Tanibirumab and Its Bispecific Antibody, DIG-KTJin-San Yoo, Ph.D., President & CEO, PharmAbcine, Inc., KoreaTanibirumab has completed a Phase I study. In contrast to other KDR pathway antagonists, Tanibirumab did not cause hypertension and hemorrhage side effects, and due to its cross-species cross reactivity, it has been possible to assess in in vivo efficacy studies. I’ll discuss Tanibirumab’s Phase I&II GBM trials, and development of bispecific next-generation products to enable Tanibirumab to reach its full potential.

11:40 Bispecific Antibody Formats Tailored for Specific ApplicationsJochen Kruip, Ph.D., Department Head, BioInnovation Novel Therapeutic Protein Formats, SanofiBesides a bispecific antibody targeting Il13- and IL4 (currently in phase II) we have further developed our original format to allow specific applications such as T cell engagement.

12:10 pm Targeted Delivery of Nanomedicines Using Bispecific AntibodiesStephen Mahler, Ph.D., Professor, Australian Institute for Bioengineering and Nanotechnology, University of QueenslandAlthough there are around 8 nanomedicines approved for cancer therapy, none of these are actively targeted to cancer receptors. Active targeting can increase the proportion of drug payload that reaches the tumour site(s). The utility of targeting nanoparticles to tumour cells with bispecific antibodies (BsAbs) is demonstrated, whereby one arm binds the nanoparticle, and the other the target. The use of BsAbs has several advantages over chemical conjugation of antibody fragments to nanoparticles.

12:40 Networking Luncheon in the Exhibit Hall with Poster Viewing and Close of Protein & Antibody Engineering Conference

PEGS CHINA | WEDNESDAY, APRIL 1

TRACK 4: CHARACTERIZATION OF BIOTHERAPEUTICSBiophysical Characterization * Aggregate Prevention * Enhancing Developability

TRACK 3: ANTIBODY-DRUG CONJUGATESClinical Experience * Payloads & Linkers * Engineering Homogeneity


3:05 Refreshment Break in the Exhibit Hall with Poster Viewing3:45 Chairperson’s RemarksWei Wang, Ph.D., Associate Research Fellow, Pharmaceutical R&D, Pfizer, Inc.

BIOPHYSICAL AND BIOCHEMICAL CHARACTERIZATION

UnpublishedData

Case Study

3:50 Characterization Study of an Antibody with Two Light ChainsZhihong Lin, Ph.D., Principal Scientist, Biologics Discovery and Design, Abbott LaboratoriesWe have characterized an antibody against Prothrombin Induced by Vitamin K Absence (PIVKA-II). Initial testing of the purified antibody by various biochemical methods contrasted with the results of the IEC. Biacore analysis demonstrated 3 populations of antibodies with varying reactivity to the antigen. Finally antibody gene sequencing showed myeloma’s endogenous light chain was present in the hybridoma and paired with the functional heavy chain.

4:20 Fast and Flexible Analysis of Fc-Gamma Receptor Sponsored by Binding Interactions on the Octet Platform Dominic Andrada, Senior Product Manager, Pall ForteBio LLC

4:35 Development of a Novel PD-1/PD-L1 Blockade Bioassayfor Antibody Therapeutics in Cancer Immunotherapy

Sponsored by

Zhi-Jie Jey Cheng, Ph.D., Group Leader, Promega CorporationCancer immunotherapy targeting PD-1/PD-L1 is showing promising results with durable clinical responses for several tumors. In this presentation I describe the development of a robust, bioluminescent, cell-based PD-1 blockade bioassay that can serve as a valuable tool in the assessment of therapeutic antibodies in drug screening, characterization, and lot release.

UnpublishedData

4:50 Microchip Electrophoresis (MCE) for Traditional and Novel Formats of Antibody-Based Biotherapeutics

Markus Haindl, Ph.D., Director, Development Analytics, Roche Diagnostics GmbH, GermanyAntibody analytics require the identification and assessment of specific antibody fragments and modifications. Microchip capillary electrophoresis (MCE) provides an automated high-throughput platform to monitor antibody quality. Here, we demonstrate the characterization of classical and novel formats of antibody-based biotherapeutics. The MCE assay shows a good linear range, high sensitivity and provides a resolution superior to CE-SDS for many aspects.

3:05 Refreshment Break in the Exhibit Hall with Poster Viewing3:45 Chairperson’s Opening RemarksRobb Kahn, M.D., Senior Safety Science Leader, Global Pediatric Oncology Drug Development, Genentech, a member of the Roche Group

ADCs IN PRECLINICAL AND CLINICAL DEVELOPMENT

»FEATURED PRESENTATION3:50 Current Clinical Experience with Antibody-Drug Conjugates: A View through the Therapeutic WindowRobb Kahn, M.D., Senior Safety Science Leader, Global Pediatric Oncology Drug Development, Genentech, a member of the Roche GroupNumerous antibody-drug conjugates (ADCs) are in clinical development and several have entered the therapeutic market. The concept of an ADC is to improve the “therapeutic window” of cancer chemotherapy. This presentation will examine the therapeutic windows for representative ADCs in clinical development, allowing us to peer into the therapeutic window of specific ADCs through a discussion of their risk-benefit profiles.


UnpublishedData

4:50 Superior Anti-Tumor Activity Compared to T-DM1 in Preclinical Studies of Targeted Therapies for Her2-positive Cancers by a Novel Her2-ADCSheldon Cao, Ph.D., CEO, Zova Biotherapeutics, Inc.ZV02-1016 is a Her2-targeting ADC based on newly developed K-LockTM technology. Anti-Her2 Ab was conjugated with highly cytotoxic auristatin analogue through a non-cleavable linker to form ZV02-1016. ZV02-1016 is shown to be more potent than T-DM1 in vitro in Her2 expressing cancer cell lines and in vivo in Her2-positive cancer cell line xenografts. ZV02-1016 is currently under further evaluation as a candidate for clinical treatment of Her2-positive cancers in future.

5:20 Application of Translational PKPD in ADC DevelopmentKedan Lin, Ph.D., Senior Scientist, Therapeutic Area Lead for Oncology Large Molecules, Pharmacokinetics & Pharmacodynamics, Genentech, Inc.

5:50 Close of Day

2:00 pm Chairperson’s Opening RemarksRobb Kahn, M.D., Senior Safety Science Leader, Global Pediatric Oncology Drug Development, Genentech, a member of the Roche Group

2:05 ADCs: Is It Time to Rethink Some Preconceptions?Shu-hui Liu, Ph.D., Associate Research Fellow, Department of Biology, Rinat-PfizerIn this presentation, we will discuss how site-specific conjugation technologies have allowed a deeper understanding of ADC properties.

2:35 Whose Problem is Post-Translational Modifications? Discovery, Cell Culture, Chromatography or Formulation?Chandrashekar Ganesa, Ph.D., Senior Director, Analytical Development, Global Biotherapeutics, SanofiRecombinant protein post-translational modifications (PTMs) are important to monitor and control during the manufacture of biologics. However, the diversity, identification and understanding the relevance of PTMs during the product development cycle can be challenging. This presentation will examine current analytical technologies and discuss how to effectively use them in

characterizing the different types of PTMs. It will also discuss various strategies to manage PTMs during various stages of therapeutic protein development.

PLENARY KEYNOTE SESSION






5:20 Analytical Characterization in Support of Protein Therapeutics Development: Linking Structure to FunctionFan Yang, Ph.D., Scientist, Analytical Development and Quality Control, Livzon MabPharm, Inc. Characterization of product heterogeneities needs to combine physicochemical and biological analysis to identify the critical quality attribute. This presentation will show several case studies of applying our analytical platform in structure and function characterization during different developmental stages. Consideration on significance and quality control of the attributes for process development is also discussed.

5:50 Close of Day




8:30 am Morning Coffee8:50 Chairperson’s Opening RemarksThomas Pillow, Ph.D., Scientist, Discovery Chemistry, Genentech, Inc.

NOVEL PAYLOADS, LINKERS AND SITES

UnpublishedData

9:00 ADCs based on RNA Polymerase II Inhibiting ToxinsAndreas Pahl, Ph.D., CSO, Heidelberg Pharma GmbHPayloads of today’s ADCs are exclusively based on compounds acting on microtubules or DNA and seem to suffer from various limitations. New generations of payloads enter the field including Heidelberg Pharma’s amanitin, a highly effective inhibitor of the eukaryotic RNA Polymerase II. Due to its unique mode of action and its hydrophilic properties, this toxin differs from well-known payloads. This presentation will summarize the current status of this new toxin.

UnpublishedData

9:30 Cancer Stem Cell Targeting with Antibody-Drug Conjugate Payloads and Linker TechnologiesRiley Ennis, MSc, Thiel Fellow, Cell and Molecular Biology, Dartmouth CollegeA challenge with current antibody-drug conjugates (ADCs) is to improve patient outcomes by circumventing drug resistance, disease recurrence, and cancer stem cells. We explore a novel cytotoxic payload, Azonafides, that can be integrated into ADC platforms. This cytotoxin is more stable in circulation, has unique mechanisms of action, and is derived from natural products. Azonafides create an exciting clinical opportunity to improve the therapeutic window, efficacy, and safety of ADCs.

10:00 New Linker Chemistries for Expanding the Utility of ADCsThomas Pillow, Ph.D., Scientist, Discovery Chemistry, Genentech, Inc.This presentation will describe the use of potent anthracycline and PBD payloads for second generation HER2-targeted ADCs, and how different linkers to these payloads can be used to tune the therapeutic activity. A new linker that takes advantage of the site-specificity of THIOMABTM technology will be described. Additionally, the presentation will describe the application of ADCs to non-oncology indications.


UnpublishedData

11:10 Engineering Homogeneous ADCs with Single or Combination WarheadsAaron Sato, Ph.D., Vice President, Research, Sutro Biopharma, Inc.Using Xpress CF+, hundreds of non-natural amino acid antibody variants are made within a day. Using fast, quantitative conjugation chemistries, antibodies are conjugated within hours with low molar excess of linker warhead. The best sites are selected based on expression, cell binding, conjugation efficiency (DAR), and cell killing. In vivo efficacy, PK/PD, and stability studies further winnow to our best ADC candidates. Multiple ADC examples will be provided.

UnpublishedData

11:40 Bidentate Linkers for Site-Specific Conjugation and Improvement of Homogeneity and Other Druggabilities in ADCBruce Nianhe Han, Ph.D., CSO, Research & Development, NewBio Therapeutics, PR ChinaWe have discovered new linkers, bis(maleimde)derivatives which can conjugate small molecule toxins to antibodies in site-specific manner. With this technology, no antibody engineering is required and we only need to use the interchain disulfide bonds of IgG to perform conjugation. The resulting final products have high percentage of ADC with defined antibody-drug ratios. These homogeneous ADCs have also shown improved in vitro and in vivo stability, and other related druggabilities.

12:10 pm Sponsored Presentation (Opportunity Available) 12:40 Networking Luncheon in the Exhibit Hall with Poster Viewing

8:30 am Morning Coffee8:50 Chairperson’s Opening RemarksBilikallahalli Muralidhara, Ph.D., Associate Director, Vaccines & Biologics, Biopharmaceutical Development, MedImmune, Inc.

CHARACTERIZING AGGREGATES AND IMPURITIES »FEATURED PRESENTATION

9:00 Kinetic and Thermodynamic Landscape of Protein AggregationBilikallahalli Muralidhara, Ph.D., Associate Director, Vaccines & Biologics, Biopharmaceutical Development, MedImmune, Inc.Protein folding and aggregation are kinetically controlled processes, however understanding and drawing correlation between the two phenomenon for large and cofactor binding proteins is fairly complex. Thermodynamics stability parameters derived from kinetic and equilibrium studies predict the propensity of protein molecules to aggregation and sub-visible/visible particle formation. Case studies of co-factor modulated protein stability and correlations to aggregation/particle formation will be presented.

9:30 Subvisible Particles in Biotherapeutics: Evolving Regulatory Landscape and Product DevelopmentSatish K. Singh, Ph.D., Research Fellow, Biotherapeutics Pharmaceutical Sciences, Pfizer, Inc.Proteinaceous particles arise from growth of aggregates and are thus an early indicator for product stability, as well as product and process consistency. These particles are also considered a risk factor for immunogenicity. Regulatory requirements on the monitoring and reporting of these particles have been enhanced. This talk will examine this evolving technical and regulatory landscape, and their incorporation into product development strategy.

UnpublishedData

10:00 New Approaches to Determine and Characterize CHO Host Cell ProteinsMarkus Haindl, Ph.D., Director, Development Analytics, Roche Diagnostics GmbH, GermanyAs HCPs may act immunogenic, their characterization during manufacturing processes is of major interest. We apply electrochemiluminescent assays combined with 2D-chromatographic fractionation to monitor HCP removal. Their profiles and coverage by anti-HCP antibodies is analyzed using 2-D Fluorescence Difference Gel Electrophoresis (2-D DIGE) and Western blot techniques.


STABILITY AND SOLUBILITY FOR ENGINEERED PROTEINS AND ANTIBODIES

UnpublishedData

11:10 Estimation of Shelf Life based on Accelerated Stability StudiesWei Wang, Ph.D., Associate Research Fellow, Pharmaceutical R&D, Pfizer, Inc.Estimation of the product shelf life is often based on accelerated stability studies during the early stage of product development. These short-term studies allow rapid evaluation and optimization of product stability. Such data, however, may not always predict accurately the real-time shelf life for biologics. This presentation discusses the general principles, challenges, and options in shelf life estimation.

11:40 Large Impact of Single Amino Acid Mutation on the Stability,

UnpublishedData

Solubility and Viscosity of Engineered Monoclonal AntibodiesMasaru Muraoka, Ph.D., Research Scientist, Discovery Research Department, Chugai Pharmaceutical Co., Ltd., JapanIn protein engineering of monoclonal antibodies, conferring pH-dependent antigen binding property is a common technique for improving therapeutic potential. However, in some cases, such protein engineering, even with single amino acid mutation, has an adverse effect on the stability, solubility and viscosity of monoclonal antibody. This talk will present case studies covering these issues and discuss the strategies for protein engineering.

PEGS CHINA | THURSDAY, APRIL 2




2:00 Chairperson’s RemarksThomas Pillow, Ph.D., Scientist, Discovery Chemistry, Genentech, Inc.

SITE-SPECIFIC CONJUGATIONS FOR PRODUCTION OF HOMOGENEOUS ADCs

2:05 Site-Specific Conjugations for Well-Defined and Stable ADCsChangshou Gao, Ph.D., Fellow, R&D, Department of Antibody Discovery & Protein Engineering, MedImmune, LLC.Significant effort has been devoted recently to developing site-specific conjugations for producing homogenous ADCs with well-defined drug to antibody ratios. This presentation will discuss our approaches to generate ADCs with different conjugation chemistries that allow precise control of conjugation site and stoichiometry. Upon conjugation to a drug, the site-specific ADCs showed enhanced stability, increased in vivo anti-tumor efficacy, and decreased off-target toxicity.

2:35 Overcoming Challenges and Enhancing Production of Antibody for Site-Specific Antibody-Drug ConjugatesMarie Zhu, Ph.D., Director, Process Sciences, Agensys, Inc./Astellas, Inc.ADCs have been emerging as a new class of anticancer therapeutics, in which monoclonal antibodies are designed to deliver a cytotoxic drug selectively to antigen expressing cells. The site-specific ADC technology we are using results in ADCs with a homogenous drug-antibody ratio. In this study, we investigate how the cell line development process impacts on antibody expression, and how feed media components and cell culture processes affect cell growth and antibody production.


12:10 Combining Raman Spectroscopy and Dynamic Light Scattering for Developing Unique Insights into Protein Structure and Stability

Sponsored by

Wei Qi, Senior Scientist, Bioscience Initiative, Malvern Instruments Inc High concentration formulation has grown into an imperative challenge to biopharmaceutical industry. In contrast to conventional technologies, Raman spectroscopy fits into this regime nicely with unique advantages: lower water signal background, wider spectra range, simultaneous measurement of secondary structure, aromatic side chain and disulfide bonds, etc. Dynamic light scattering further expands the horizontal of the knowledge by providing size distribution without sample and instrument variations. Such hybrid characterization technologies are synergistic based on tandem measurements.

12:40 Networking Luncheon in the Exhibit Hall with Poster Viewing2:00 Chairperson’s Opening RemarksBilikallahalli Muralidhara, Ph.D., Associate Director, Vaccines & Biologics, Biopharmaceutical Development, MedImmune, Inc.

CHALLENGES IN BIOPHARM DEVELOPMENT AND COMMERCIALIZATION

2:05 Glycosylation, Charge Distribution and In Vivo Half Life of Follow-on BiologicsYan Huang, Ph.D., Associate Director, Bioanalytical Development, Alphamab

2:35 The Challenges and Strategies of Development and Commercialization of High Quality Biopharmaceutical ProductSpeaker to be AnnouncedSuccessful development and manufacturing of a high quality product require having a closely controlled and robust manufacturing process, a well-designed formulation, and sensitive and reliable analytical methods. In this presentation, we will discuss our overall strategy and highlight some of the key steps during the product development and manufacturing to ensure our product quality. Several case studies, including mAbs and ADCs will be discussed.

3:05 Simplifying Biotherapeutic Analysis with Novel ImmunoassaysJohn Proctor, Director, Marketing , ProteinSimple

Sponsored by

Immunoassays are a critical part of research today in both academia and BioPharma. Today, there exists thousands of immunoassays that are difficult to operate and which include manual steps that prevent the reproducibility required for biotherapeutic development. ProteinSimple has redefined the Western blot with the release of it’s Simple Western platform.

3:35 Refreshment Break





4:00 Chairperson’s RemarksGayathri Ratnaswamy, Ph.D., Director, Analytical & Formulation, Agensys, Inc.

4:05 Analytical Strategies and Characterization of Antibody-Drug ConjugatesGayathri Ratnaswamy, Ph.D., Director, Analytical & Formulation, Agensys, Inc.This presentation will focus on the challenges of analytical method development and characterization for ADCs in comparison with that of mAbs using case studies. Strategies for the analytical development for early stage versus late stage will be presented.

4:35 ADCs: Biophysical Characteristics and Impact on Product and ProcessSatish K. Singh, Ph.D., Research Fellow, Biotherapeutics Pharmaceutical Sciences, Pfizer, Inc.The biophysical characteristics of ADCs are strongly impacted by the chemistry and associated linker-payload. A strong understanding of these characteristics is therefore important for robust product and process development. This talk will cover some examples illustrating these aspects for ADCs.

5:05 Close of Conference 5:05 Close of Conference

JOINT CLOSING SESSION: Characterizing ADCs for Better Developability



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MARCH 31 - APRIL 2, 2015€¦ · chemistries, while developing strategies for homogeneity engineering and biophysical characterization of ADCs. Track 2: Phage & Yeast Display 噬菌体和酵母展示