KEYNOTE AND FEATURED SPEAKERS Raymond J. Deshaies, PhD Amgen, Inc. Ron Weiss, PhD Massachusetts Institute of Technology Michaela W. Bowden, PhD Bristol-Myers Squibb Co. Roderick Chalk, PhD Structural Genomics Consortium, UK K. Dane Wittrup, PhD Massachusetts Institute of Technology NEXT GENERATION TOOLS & FORMATS 4 DAYS | 4 FOCUSED TOPICS Cambridge Healthtech Instute’s 2nd Annual VIRTUAL JULY 19-22, 2021 EASTERN DAYLIGHT TIME Explore the latest biotherapeutics research and strategies for accelerating biologics development. Network with protein engineering professionals, share your ideas and gain insights. Register for a single day or attend all four! These resources will be available on-demand for you to leverage after the event at your convenience. RESERVE YOUR SPOT BY JULY 9 FOR SAVINGS UP TO $200 Matthew P. DeLisa, PhD Cornell University PEGSymposium.com REGISTER PAGE 1 #PEGSymposium NEXT
Transcript
KEYNOTE AND FEATURED SPEAKERS
Raymond J. Deshaies, PhDAmgen, Inc.
Ron Weiss, PhDMassachusetts Institute of Technology
Michaela W. Bowden, PhDBristol-Myers Squibb Co.
Roderick Chalk, PhDStructural Genomics Consortium, UK
K. Dane Wittrup, PhDMassachusetts Institute of Technology
NEXT GENERATION TOOLS & FORMATS4 DAYS | 4 FOCUSED TOPICS
Cambridge Healthtech Institute’s 2nd Annual
VIRTUAL
JULY 19-22, 2021 EASTERN DAYLIGHT TIME
Explore the latest biotherapeutics research and strategies for accelerating biologics development. Network with protein engineering professionals, share your ideas and gain insights.
Register for a single day or attend all four! These resources will be available on-demand for you to leverage after the event at your convenience.
RESERVE YOUR SPOT
BY JULY 9 FOR SAVINGS UP
TO $200
Matthew P. DeLisa, PhDCornell University
PEGSymposium.com REGISTER PAGE 1#PEGSymposium NEXT
DAY 1: Monday, July 19 DAY 2: Tuesday, July 20 DAY 3: Wednesday, July 21 DAY 4: Thursday, July 22
REGISTER FOR A SINGLE DAY OR ATTEND ALL FOUR!Access presentations from industry experts working across the entire spectrum of biopharmaceutical development and production. These resources will be available on-demand for all registered participants.
ABOUT THE EVENT
CHI’s PEGS Summit Series is excited to introduce the PEGS Summer Symposium, providing four full days of cutting-edge developments in protein engineering, solid tumor targeting, mass spectrometry and protein expression. Each daily agenda takes a deep dive into one of these topic-focused areas, offering participants presentations, panel discussions, networking, and live dialogue with speakers.
The PEGS Summit Series portfolio of acclaimed conferences, including the flagship biologic events PEGS Boston and PEGS Europe, plays an integral role in connecting the international biotherapeutics community. The PEGS Summer Symposium aims to foster research collaboration and advance our understanding of protein engineering.
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• Attendee leads, including full contact information for your presentation and session
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BISPECIFICS FOR T CELL ENGAGEMENT: ARE THEY COMPETING OR COMPLEMENTARY WITH CAR Ts?9:00 am Chairperson’s RemarksShelley Force Aldred, PhD, CEO, Rondo Therapeutics
9:05 Combining CAR T Cells with Oncolytic Viruses Expressing BiTEsSònia Guedan, PhD, Principal Investigator, Hematology & Oncology, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)CAR T cells and BiTEs immunotherapies have many challenges ahead before they can be used effectively to treat solid tumors, including tumour-antigen heterogeneity and an immunosuppressive tumour microenvironment. Combination of CAR T cells with oncolytic viruses expressing BiTEs locally at the tumor exploits the best features of each therapy, while overcoming many of the hurdles encountered by these therapies as single agents.
9:40 Trispecific Antibody Platform for Tumor Specific T Cell EngagersPieter Fokko van Loo, PhD, Senior Director, Oncology – Immunology, Merus NVThe expression of tumor associated antigens (TAA) on solid tumors and normal tissue limits the therapeutic potential of T cell engagers to fight solid tumors. Solid tumor selectivity can be created by targeting two tumor targets (TAA1xTAA2) that are only co-expressed on solid tumors and not on normal tissue. TAA1xTAA2xCD3 Triclonics™ provide therapeutic opportunities for T cell engagers in solid tumors.
10:15 KEYNOTE PRESENTATION: Bispecific T Cell Engagers: Whither Are We Bound?Raymond J. Deshaies, PhD, Senior Vice President, Global Research, Amgen Inc.
Blincyto blinatumomab was the second bispecific T cell engager (TCE) to secure regulatory approval and the first to deliver value. Nearly 7 years after its approval, it remains the only T cell engager on the market. My presentation will consider where we, as a field, have been, and where we are going.
10:50 Engineering Bispecific CAR T Cells for Hematological and Solid MalignanciesYvonne Y. Chen, PhD, Associate Professor, Microbiology & Immunology & Molecular Genetics, University of California, Los AngelesThe adoptive transfer of T cells expressing chimeric antigen receptors (CARs) has demonstrated clinical efficacy in the treatment of advanced cancers, with anti-CD19 CAR T cells achieving up to 90% complete remission among patients with relapsed B-cell malignancies. However, challenges such as antigen escape and immunosuppression limit the long-term efficacy of adoptive T cell therapy.
11:25 Generating Immuno-Modulatory Bispecific Therapeutic Candidates for the Treatment of Hematologic and Solid TumorsJane A. Gross, PhD, Senior Vice President of Research and Development and CSO, Aptevo Therapeutics, Inc.I will describe many of the desired features, unique to the ADAPTIR and ADAPTIR-FLEX platform technologies, that enable the generation of bispecific and multi-specific therapeutic candidates with potential to mediate different mechanisms of action for treatment of cancer.
NEXT GENERATION TOOLS & FORMATS
VIRTUAL | JULY 19-22, 2021
Bispecifics for T-Cell Engagement | Remodeling the Tumor MicroenvironmentThe PEGS Summer Symposium is in its 2nd year and brings together the engineering community in the virtual environment. In the first half of the Engineering track on Monday, July 19, we will highlight the important advances in engineering bispecific antibodies for eliciting a T cell response featuring a discussion on the direct comparison of relative advantages and disadvantages against CAR T approaches. How do the two approaches stack up in terms of safety, manufacturability, customization, efficacy and durability of response? Leaders in the field will highlight differences in this direct, head-to-head comparison. In the second half, we will highlight current thinking on targeting the tumor microenvironment instead of the tumor itself, including new strategies, latest clinical data and the relative merit of targeting different immune cell populations.
ENGINEERINGDAY 1 | JULY 19, 2021 | EDT
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12:00 pm INTERACTIVE LIVE PANEL DISCUSSION: Bispecifics vs CAR T Therapy for T Cell Engagement: Competing or Complementary?Moderator: Shelley Force Aldred, PhD, CEO, Rondo Therapeutics• For BsAb developers, in which biological or clinical scenarios would you wish to have access to CAR Ts instead? For CAR T developers, when would you prefer to have a BsAb?• Are the two modalities going to have to compete in the long run or will they settle into non-overlapping market niches?• If you had access to both modalities, how might you use them together?Panelists:Sònia Guedan, PhD, Principal Investigator, Hematology & Oncology, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)Pieter Fokko van Loo, PhD, Senior Director, Oncology – Immunology, Merus NVRaymond J. Deshaies, PhD, Senior Vice President, Global Research, Amgen Inc.Yvonne Y. Chen, PhD, Associate Professor, Microbiology & Immunology & Molecular Genetics, University of California, Los AngelesJane A. Gross, PhD, Senior Vice President of Research and Development and CSO, Aptevo Therapeutics, Inc.
12:20 Session Break
REMODELING THE TUMOR MICROENVIRONMENT: THERAPEUTIC STRATEGIES1:00 Chairperson’s RemarksJennifer R. Cochran, PhD, Shriram Chair & Professor, Bioengineering & Chemical Engineering, Stanford University
1:05 KEYNOTE PRESENTATION: Occam’s Pharmacokinetics: Theoretical and Experimental Investigations of Intralesional ImmunotherapiesK. Dane Wittrup, PhD, CP Dubbs Professor,
Chemical Engineering & Bioengineering, Massachusetts Institute of TechnologyTraditional oncological principles held that it was essential for an administered cytotoxic or signal-blocking drug to reach every single cancer cell in the body - an unattainable goal that almost inevitably results in the emergence of drug resistance. The advent of immune oncology has shifted the burden of tumor cell elimination to the adaptive immune system, which patrols everywhere in the body.
1:40 Engineered Protein Therapeutics that Transform the Tumor MicroenvironmentJennifer R. Cochran, PhD, Shriram Chair & Professor, Bioengineering & Chemical Engineering, Stanford UniversityPrevious innovations in protein therapeutics have focused on modulating biochemical pathways that drive phenotypic hallmarks of cancer. Next-generation engineered proteins that target stromal factors or invoke immune cell activation to drive remodeling of an immunosuppressive tumor microenvironment will be discussed.
2:15 Tumor-Targeted Immune-Stimulating Antibody ConjugatesDavid Dornan, PhD, Chief Scientific Officer, Bolt Biotherapeutics, Inc.Immune-stimulating antibody conjugates (ISACs) are tumor-targeting antibodies conjugated with powerful innate immune stimulants, such as TLR7/8 agonists, and are capable of invoking localized potent myeloid cell activation and the production
of pro-inflammatory cytokines that favor a productive anti-tumor immune response. ISACs are active in preclinical in vivo models of cancer and are highly efficacious by enhancing ADCP, promoting antigen presentation, immunological memory, and epitope spreading.
2:50 Myeloid Tuning of the Tumor Microenvironment Using Glyco-Engineered Antibodies for Therapeutic DevelopmentLinda Liang, PhD, Project Leader, Antibody Generation & Protein Sciences, Pionyr Immunotherapeutics Inc.Pionyr’s Myeloid Tuning approach involves altering the composition and the function of myeloid cells in the TME to promote anti-tumor responses. This presentation will discuss therapeutic approaches for Myeloid Tuning using glyco-engineered antibodies to targets in the TME.
3:25 INTERACTIVE LIVE PANEL DISCUSSION: Remodeling the Tumor Microenvironment: Therapeutic StrategiesModerator: Jennifer R. Cochran, PhD, Shriram Chair & Professor, Bioengineering & Chemical Engineering, Stanford University• Immune cell-mediated remodeling of the tumor
microenvironment as a new paradigm for treatment• Protein therapeutics that invoke immune cell activation /
adaptive immune response• Therapeutic approaches for intratumoral versus systemic
administration• Novel and emerging therapeutic targets for immuno-oncology Panelists:K. Dane Wittrup, PhD, CP Dubbs Professor, Chemical Engineering & Bioengineering, Massachusetts Institute of TechnologyDavid Dornan, PhD, Chief Scientific Officer, Bolt Biotherapeutics, Inc.Linda Liang, PhD, Project Leader, Antibody Generation & Protein Sciences, Pionyr Immunotherapeutics Inc.
3:45 End of Day
ENGINEERING CONTINUED
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UNDERSTANDING AND TARGETING SOLID TUMORS8:25 am Chairperson’s RemarksMitchell Ho, PhD, Senior Investigator; Deputy Chief, Laboratory of Molecular Biology; Director, Antibody Engineering Program, National Cancer Institute (NCI), NIH
8:30 Precision Engineered Multifunctional Therapeutics to Overcome Cancer Resistance to ImmunotherapyYan Chen, PhD, Founder & CEO, Elpis BiopharmaceuticalsWe have developed novel platforms for antibody discovery and protein engineering. Utilizing the technologies, we have discovered EPIM-001, an IL2Rb agonist/anti-PDL1 bispecifics. It demonstrated selective immune cell activation and potent anti-tumor growth activities against solid tumors in mice. We have incorporated the engineered IL2 as an armor in CAR T to enhance the efficacy for solid tumors.
9:05 IGM Antibodies with Very Potent Agonism to DR-5 Induced Apoptosis and as Anti-Tumor AgentsBruce Keyt, PhD, CSO, R&D, IGM Biosciences, Inc.We have engineered a multivalent IgM antibody IGM-8444 containing 10 binding sites for efficient DR5 multimerization and agonism. IGM-8444 was cytotoxic across cell lines from 18 solid and hematologic malignancies in vitro though did not induce
cytotoxicity of primary hepatocytes. In vivo, IGM-8444 induced complete and durable dose-dependent tumor regressions in a gastric PDX model and tumor growth inhibition in other CDX and PDX models.
9:40 KEYNOTE PRESENTATION: Elucidating Underlying Mechanisms of IO ResistanceMichaela W. Bowden, PhD, Executive Director, Solid Tumor Disease Team, Bristol-Myers
Squibb Co.As the field of cancer immunotherapy continues to advance at a fast pace, treatment approaches and drug development are evolving rapidly to maximize patient benefit. This presentations discusses our current understanding of solid tumor biology and mechanisms of IO resistance.
10:15 Talk Title to be AnnouncedSpeaker to be Announced
10:30 Session Break
10:50 KEYNOTE PRESENTATION: CAR T Cells Targeting GPC3 and GPC2 for Treating Liver Cancer and NeuroblastomaMitchell Ho, PhD, Senior Investigator; Deputy
Chief, Laboratory of Molecular Biology; Director, Antibody Engineering Program, National Cancer Institute (NCI), NIH
I will discuss the biology of cancer driven by heparan sulfate proteoglycans, in particular GPC3 and GPC2, and the generation of CAR T cells to treat solid tumors such as liver cancer and neuroblastoma. I will also describe new strategies using genomics and RNAseq techniques to improve and analyze the tumor specificity and persistence of CAR T cells.
11:25 The Role of NK Cells in Tackling Solid TumorsAlicja J. Copik, PhD, Associate Professor, Medicine Cancer Research Division, Burnett School of Biomedical Sciences, UCF College of MedicineImmuno-oncology is a treatment approach that works by augmenting the body’s own immune system. While immune checkpoint inhibitors enhance T cells’ antitumor response, NK cells also play crucial role in the efficacy of immunotherapies. This talk will highlight the advances made in development of NK cell therapeutics focusing on the NK cells, expanded with PM21 particle platform and evidence supporting combinatorial application with other immune-oncology approaches to improve outcomes.
12:00 pm INTERACTIVE LIVE PANEL DISCUSSION: Tools, Targets and Novel Approaches towards Solid TumorsModerator: Mitchell Ho, PhD, Senior Investigator; Deputy Chief, Laboratory of Molecular Biology; Director, Antibody Engineering Program, National Cancer Institute (NCI), NIHPanelists:Michaela W. Bowden, PhD, Executive Director, Solid Tumor Disease Team, Bristol-Myers Squibb Co
NEXT GENERATION TOOLS & FORMATS
VIRTUAL | JULY 19-22, 2021
Developing Immunotherapies for Solid TumorsImmunotherapy has proven itself to be a formidable weapon in the treatment of cancer; however, treating solid tumors remains a significant challenge due to issues around durability, efficacy and targeting. This track explores the recent advances and current challenges in the development of immunotherapies for patients with solid tumors, focusing on understanding and modulating the tumor microenvironment, new targets, novel engineering approaches, preclinical and clinical updates, as well as next-generation approaches for both cell-based and non cell-based immunotherapies.
ONCOLOGYDAY 2 | JULY 20, 2021 | EDT
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Yan Chen, PhD, Founder & CEO, Elpis BiopharmaceuticalsBruce Keyt, PhD, CSO, R&D, IGM Biosciences, Inc.Alicja J. Copik, PhD, Associate Professor, Medicine Cancer Research Division, Burnett School of Biomedical Sciences, UCF College of Medicine
12:20 Session Break
LATEST ENGINEERING STRATEGIES TO COMBAT SOLID TUMORS12:40 Chairperson’s RemarksNeil Sheppard, DPhil, Head, T Cell Engineering Laboratory, Centre for Cellular Immunotherapy, University of Pennsylvania
12:45 Engineering CARs for Solid TumorsPaul Neeson, PhD, Associate Professor, Cancer Immunoloy Research, Peter MacCallum Cancer CentreWe developed a new second generation CAR comprising a truncated human CD34, a scFV directed to Lewis Y, and endodomains CD28-CD3zeta in T cells that were enriched for ‘early’ T cells (stem cell and central memory-like). These “early” CAR T had enhanced proliferation, generating diverse progeny with increased cytotoxic function increased cytokine/chemokine secretion, and better in vivo therapy responses.
1:20 CAR T Signaling Optimization to Address the Challenges of Solid TumorsYi Wen, PhD, Postdoctoral, T Cell Engineering Lab, Centre for Cellular Immunotherapies, University of PennsylvaniaCAR design requires significant optimization to meet the challenges of solid tumors including the expression of target antigens at lower levels by healthy tissues, the suppressive tumor microenvironment, and the propensity of CARs to mediate tonic- or excessive signaling. We explored different designs for Signal 1 and show that the CAR activation threshold and consequently the in vitro and in vivo activity can be tuned to suit specific requirements.
1:55 Enhancing CAR T Cell Activity for Solid Tumors Using TurboCARTM TherapyRegina J. Lin, PhD, Principal Scientist, Allogene TherapeuticsChallenges surrounding solid tumors include a rarity of lineage-specific targets and the presence of immune-suppressive milieus. Here, we demonstrate that allogeneic CAR T cells directed towards CD70 and DLL3 show good preclinical activity against renal cell and small cell lung cancers, respectively. Coexpression of a Turbo domain that confers cell-intrinsic cytokine signaling further enhances CAR T cell activity.
2:30 Scalable Engineering of Cellular Therapies for Solid TumorsTheodore Roth, PhD, Graduate Student, Microbiology & Immunology, University of California, San Francisco; Co-Founder, Arsenal BioEffective cellular therapies for solid tumors have proved elusive. We present new platforms to rapidly assess the functional effects of large pools of T cell genetic modifications in parallel non-virally. Pooled knock-ins combined with single-cell sequencing also revealed high-dimensional cellular phenotypes associated with improved clearance of solid tumor xenografts. Scalable discovery and engineering of T cell therapies will enable more rapid clinical development of curative cell therapies for solid tumors.
3:05 INTERACTIVE LIVE PANEL DISCUSSION: Novel Engineering Approaches to Solid TumorsModerator: Neil Sheppard, DPhil, Head, T Cell Engineering Laboratory, Centre for Cellular Immunotherapy, University of PennsylvaniaPanelists:Paul Neeson, PhD, Associate Professor, Cancer Immunoloy Research, Peter MacCallum Cancer CentreYi Wen, PhD, Postdoctoral, T Cell Engineering Lab, Centre for Cellular Immunotherapies, University of PennsylvaniaRegina J. Lin, PhD, Principal Scientist, Allogene TherapeuticsTheodore Roth, PhD, Graduate Student, Microbiology & Immunology, University of California, San Francisco; Co-Founder, Arsenal Bio
3:25 End of Day
ONCOLOGY CONTINUED
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THE FUTURE COURSE OF MASS SPECTROMETRY9:00 am Organizer’s RemarksKent Simmons, Senior Conference Director, Cambridge Healthtech Institute
9:05 Industry Perspective on Emerging Tools and Technologies for Mass Spectrometric Characterization of BiologicsHarsha Gunawardena, PhD, Senior Scientist, Mass Spectrometry, Janssen Pharmaceutical Companies of Johnson & JohnsonOver the last two decades, rapid growth in biotherapeutics has led to an increasing need for technologies that will support the characterization of molecules that are increasing in complexity. We present several emerging mass spectrometry-based technologies that will dramatically improve data quality and throughput in biologics R&D. The development of new tools to tackle unique problems in biopharma characterization and finding new applications for existing technologies will be presented.
9:45 KEYNOTE PRESENTATION: Functional Analysis and Quality Control for Difficult ProteinsRoderick Chalk, PhD, Head, Mass Spectrometry, Structural Genomics Consortium, United Kingdom
Bottom-up approaches relying on sophisticated data analysis algorithms are not always able to meet the analytical challenges posed by membrane proteins, glycoproteins, IDPs and heteromultimers. Our work relies on combining bottom-up, top-down and native, alongside a thorough understanding of the proteins and methods used. We show that novel approaches to native mass spectrometry reveal the central role this technique will play in drug discovery, functional analysis and genuine quality control.
10:20 CO-PRESENTATION: Technology innovations to enable rapid, comprehensive intact and peptide map characterization of biotherapeuticsElliott Jones, Senior Director CE/Biopharma Applications Development, Americas, SCIEXMaggie Ostrowski, PhD, Senior Manager, Marketing, CE & Biopharma, SCIEXBiotherapeutics are a complex, heterogeneous class of drugs that require multiple analytical platforms to fully characterize them. Mass spectrometry holds promise for reducing timeline, investment, and risk associated with the characterization of a biotherapeutic. A new MS front-end iCIEF separation technology,
coupled with an innovative MS (ZenoTOF 7600 system, SCIEX) capable of enhanced fragmentation techniques, provides improved insights into PTM analysis, glycopeptide analysis, charge variant peak ID, & intact mass analysis.
10:55 Higher Resolution Native Ion Mobility Mass SpectrometryArthur Laganowsky, PhD, Associate Professor, Chemistry, Texas A&M UniversityAdvancements in ion mobility mass spectrometry (IM-MS) technology are opening new opportunities to investigate intact protein complexes. I will highlight our recent work resolving individual lipid binding events to human two-pore domain potassium channels leading to the identification of lipids that activate these channels. In addition, IM-MS reveals different molecular assemblies of the catalytic domain of Sons of Sevenless (SOS) in complex with wild-type and oncogenic mutants of KRas.
11:30 The Challenge of Structural Heterogeneity in the Intact-mass Analysis of Biopharmaceutical Products and their Complexes with Therapeutic TargetsIgor A. Kaltashov, PhD, Professor, Chemistry, University of Massachusetts AmherstIntact-mass MS measurements have become a popular tool in characterization of protein therapeutics, but their application to systems exhibiting high extent of structural heterogeneity remain challenging. In many cases this problem can be effectively addressed using cross-path reactive chromatography with MS detection and/or limited charge reduction in the gas phase.
NEXT GENERATION TOOLS & FORMATS
VIRTUAL | JULY 19-22, 2021
Future Directions in Mass Spectrometry and MAMThe PEGS Summer Symposium Analytical Track for 2021 will focus on best practices and emerging technologies that will impact the speed and quality of biopharmaceutical R&D in the coming years. An opening session takes a deep dive into the current trends in instruments, methods and applications for mass spectrometric analysis and their potential impacts in biopharmaceutical research and development. The afternoon session then considers how developments in new workflows (such as multi-attribute method “MAM”), software and instrument combinations will drive MS tools to replace legacy methods and enter the QC lab.
DAY 3 | JULY 21, 2021 | EDT
ANALYTICAL
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These approaches will be discussed using several examples, including extensively glycosylated proteins, synthetic vaccines, large immune complexes and heparin-related products.
12:05 INTERACTIVE LIVE PANEL DISCUSSION: Trends in Mass Spectrometry Instruments and ApplicationsModerator: Harsha Gunawardena, PhD, Senior Scientist, Mass Spectrometry, Janssen Pharmaceutical Companies of Johnson & JohnsonPanelists:Roderick Chalk, PhD, Head, Mass Spectrometry, Structural Genomics Consortium, United KingdomIgor A. Kaltashov, PhD, Professor, Chemistry, University of Massachusetts AmherstArthur Laganowsky, PhD, Associate Professor, Chemistry, Texas A&M UniversityElliott Jones, Senior Director CE/Biopharma Applications Development, Americas, SCIEXMaggie Ostrowski, PhD, Senior Manager, Marketing, CE & Biopharma, SCIEX
12:25 Session Break
MULTI-ATTRIBUTE METHOD (MAM) AND WORKFLOW COMBINATIONS12:40 Chairperson’s RemarksAlex Chen, PhD, Scientist, Protein Analytical Chemistry, Vir Biotechnology Inc.
12:45 Applying LC-MS MAM during QbD-Based Development of an AntibodyPatrick S. Merkle, PhD, Postdoctoral Researcher, Analytical Development & Characterization, Mass Spectrometry, Novartis Pharma AG, SwitzerlandThe LC-MS Multi-Attribute Method (MAM) is a peptide mapping-based approach that allows for end-to-end collection of unique and high-quality data during the Quality by Design-Based development of new biological entities. The presentation will highlight our vision for LC-MS MAM as a key technology for the risk assessment of product quality attributes and will summarize recent technical as well as project-related accomplishments with this approach.
1:20 USP Standards to Support Multi-Attribute MethodsDiane McCarthy, PhD, Director, Biologics Pipeline Development, Global Biologics, US PharmacopeiaUse of Multi-attribute Methods (MAM) for analytical testing of biotherapeutics is increasing due to their potential to improve efficiency and provide detailed information on quality attributes. Based on stakeholder input, USP has established an Expert Panel to develop a chapter on MAM and initiated studies to help enhance the robustness and consistency of MAM. This presentation will provide an update on these efforts and opportunities for stakeholders to provide feedback.
1:55 The Quantitation of PS80 with QDa-Based MSHe Meng, Senior Scientist, Analytical Development, SanofiPolysorbate 80 is a commonly used excipient for multiple Sanofi biotherapeutics, including antibodies, antibody-drug conjugates (ADCs), enzyme replacement therapies (ERTs), and gene therapies, to ensure their stability. Here we present a UPLC-QDa MAM method and explore its potential for replacing the current QC method by LC-CAD and the investigational method by 2D-LC-CAD.
2:30 Rapid Developability Assessment of COVID-19 mAb Candidates with an Extra Disulfide Bond Using Mass Spectrometry MAMAlex Chen, PhD, Scientist, Protein Analytical Chemistry, Vir Biotechnology Inc.During the pandemic, a rapid developability assessment method has been essential to support protein engineering design and the selection of lead therapeutic antibody candidates. Herein, we introduce the combination of forced degradation methods and peptide mapping MS to monitor several critical quality attributes, including labile residues and disulfide linkages. We will also show a good correlation between analytical assays, X-ray structures and their functional readout.
3:00 INTERACTIVE LIVE PANEL DISCUSSION: Trends in the Development and Application of Multi-Attribute Method (MAM)Moderator: Xiaoyan Guan, PhD, Senior Scientist, Process Development, Amgen Inc.Panelists:Alex Chen, PhD, Scientist, Protein Analytical Chemistry, Vir Biotechnology Inc.Diane McCarthy, PhD, Director, Biologics Pipeline Development, Global Biologics, US PharmacopeiaHe Meng, Senior Scientist, Analytical Development, SanofiPatrick S. Merkle, PhD, Postdoctoral Researcher, Analytical Development & Characterization, Mass Spectrometry, Novartis Pharma AG, Switzerland
3:20 End of Day
ANALYTICAL CONTINUED
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EXPANDING EXPRESSION TOOLS VIA SYNTHETIC BIOLOGY 9:00 am Chairperson’s RemarksChairperson’s Name
9:05 Assessing Optimal: Inequalities in Codon Optimization AlgorithmsMatthew J. Ranaghan, PhD, Research Scientist, Center for the Development of Therapeutics, Broad InstituteSynthetic DNA sequences have become a normalized resource in recombinant protein work, moving away from native cDNA. Despite the general acceptance of using synthetic DNAs, there is little guidance for what defines a codon optimized sequence and most commercial vendors offer a custom DNA optimization tool. We surveyed nine algorithms and found a high variability between optimized DNAs that led to a set of best practices when designing synthetic DNAs.
9:40 KEYNOTE PRESENTATION: A ‘Poly-Transfection’ Method for Rapid, One-Pot Characterization and Optimization of Genetic SystemsRon Weiss, PhD, Professor, Biological
Engineering, Massachusetts Institute of TechnologySynthetic biology is revolutionizing how we conceptualize
and approach the engineering of biological systems. Recent advances in the field are allowing us to expand beyond the construction and analysis of small gene networks towards the implementation of complex multicellular systems with a variety of applications. I will describe our integrated computational/experimental approach to engineering complex behavior in a variety of cells, with a focus on mammalian cells.
10:15 Talk Title to be AnnouncedSpeaker to be Announced
DEVELOPING A PRODUCTION PROGRAMMING LANGUAGE FOR E. COLI
10:50 Improving Soluble Expression in Escherichia coli Using Toolbox Elements and a Miniaturized Fed-Batch Fermentation Screening PlatformMartin Wagenknecht, PhD, Associate Director, Molecular Biology & Expression Systems, Boehringer IngelheimEscherichia coli represents an important workhorse for the manufacturing of a multitude of products, such as therapeutic proteins. As different target proteins place different demands on the expression system, the necessity for a broad spectrum of expression tools is created. This talk will focus on the soluble expression of biopharmaceuticals showing the potential of selected toolbox elements and their screening using an automated tailor-made mini bioreactor system.
11:25 Rational Tuning of Gene Expression Dynamics in Escherichia coliCasim A. Sarkar, PhD, Associate Professor, Biomedical Engineering, University of MinnesotaGene expression in Escherichia coli has traditionally been considered in the context of steady-state responses to small-molecule inducers. However, as more sophisticated genetic programs are created in these bacteria, new approaches are needed to control their gene expression. This talk will describe recent work in our lab to rationally shape inducible response dynamics in E. coli.
12:00 pm INTERACTIVE LIVE PANEL DISCUSSION: Exploring and Expanding Expression ToolsModerator: Martin Wagenknecht, PhD, Associate Director, Molecular Biology & Expression Systems, Boehringer IngelheimPanelists:Matthew J. Ranaghan, PhD, Research Scientist, Center for the Development of Therapeutics, Broad InstituteCasim A. Sarkar, PhD, Associate Professor, Biomedical Engineering, University of MinnesotaRon Weiss, PhD, Professor, Biological Engineering, Massachusetts Institute of TechnologySpeaker to be Announced
12:20 Session Break
NEXT GENERATION TOOLS & FORMATS
VIRTUAL | JULY 19-22, 2021
New Engineering Tools to Expand the Expression and Production of ToolboxesThe complexity of biotherapeutics and the increasing demands of “faster, better, less expensive” resonate with recombinant protein expression and production researchers. Many variables still must be considered during the development process, including verification and sequence analysis of the gene or protein of interest, codon optimization, vector construction and clone/host selection – a time-consuming and expensive process. To meet these demands, protein production scientists continue exploring new engineering tools to expand their expression and production toolbox. Ultimately, as with any new system, these tools must be weighed against traditional expression and production strategies to achieve the desired quantity and quality.
EXPRESSIONDAY 4 | JULY 24, 2021 | EDT
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SAMPLING THE DESIGN SPACE AND EXPRESSION STRATEGIES FOR BIOTHERAPEUTICS 1:00 Chairperson’s RemarksRaja Srinivas, PhD, Co-Founder, Asimov, Inc.
1:05 Accelerating Protein Design with Generative Machine LearningVykintas Jauniškis, CSO and Co-founder, Biomatter DesignsMachine learning driven protein design is a promising approach to accelerate protein engineering and is the main focus of Biomatter Designs. Our latest work shows that generated and experimentally tested enzymes are soluble when expressed in E. coli and display catalytic activity in vitro, including a variant with 106 amino acid substitutions. This work demonstrates the potential of AI to rapidly generate diverse, functional proteins within the allowed biological constraints.
1:40 Finding and Developing Therapeutic Cocktails Consisting of Multiple Nanobodies for CoVid TherapiesYi Shi, PhD, Assistant Professor, Cell Biology, University of PittsburghUsing a robust nanobody(Nb) pipeline, we have discovered > 8,000 multi-epitope, high-affinity SARS-CoV-2 Nbs including ultrapotent and stable Nbs that inhibit infection at sub-ng/ml concentrations. We bioengineered multivalent constructs with potency <0.1 ng/ml. Aerosol delivery of a lead construct decreases lung viral titers by 6-logs leading to drastically mitigated lung pathology and prevents pneumonia. Systematic structure-function analysis reveals that potent neutralizing Nbs are highly resistant to the convergent variants.
2:15 FEATURED PRESENTATION: Cell-Free Synthetic Glycobiology: Designing and Engineering Glycomolecules Outside of Living CellsMatthew P. DeLisa, PhD, William L. Lewis Professor
of Engineering, Chemical & Biomolecular Engineering, Cornell UniversityCell-based production of homogeneous glycoproteins remains a significant challenge. We have developed and optimized a first-of-its-kind cell-free glycoprotein synthesis (CFGpS) system that permits controllable biosynthesis and conjugation of customized glycans to target proteins of interest both in one-pot reaction vessels and microfluidic architectures. In this talk, I will discuss these CFGpS platforms and how they are being used for the creation of human therapeutic proteins and vaccines.
2:50 Novel Solutions for high throughput antibody and protein purification using magnetic beads.Sean Taylor, Field Application Scientist Manager, Catalog Products, GenScript Inc.With the ever-increasing demand for antibody and protein-based therapeutics, a flexible purification platform that can handle low to high sample volumes is critical. Magnetic beads-based purification permits the incubation of the beads directly into cell culture or crude lysates. This provides a simplified approach to direct target capture while eliminating much of the sample preparation steps. The tools and their application to simplify protein purification will be described.
3:25 Optimizing the Glycoform for Potent BiotherapeuticsNathan Lewis, PhD, Associate Professor, Pediatrics and Bioengineering, University of California, San Diego (UCSD)With most top blockbuster drugs being glycoproteins, there is a growing interest in engineering their glycan structures for improved safety, efficacy, and manufacturing. Using our systems biology and AI approaches, we can predict the modifications needed to effectively glycoengineer proteins. We further have explored the more global impacts glycoengineering has on the host cell and on drug efficacy, thus helping to define the design space for mammalian-cell-produced glycoproteins.
4:00 INTERACTIVE LIVE PANEL DISCUSSION: Sampling the Design Space and Expression Strategies for BiotherapeuticsModerator: Raja Srinivas, PhD, Co-Founder, Asimov, Inc.Panelists:Matthew P. DeLisa, PhD, William L. Lewis Professor of Engineering, Chemical & Biomolecular Engineering, Cornell UniversityVykintas Jauniškis, CSO and Co-founder, Biomatter DesignsNathan Lewis, PhD, Associate Professor, Pediatrics and Bioengineering, University of California, San Diego (UCSD)Yi Shi, PhD, Assistant Professor, Cell Biology, University of PittsburghSean Taylor, Field Application Scientist Manager, Catalog Products, GenScript Inc.
4:20 End of Day
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