短期課程

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2024年5月12日（日） 2:00 - 5:00 pm

SC2: How to Use and Improve Microbial Expression Systems for Recombinant Protein Production

Many different microbial expression systems are used for recombinant protein production. The choice of an expression system and the way it is used can greatly influence protein production yields. This raises some important questions: what is a suitable expression system for a particular application, how should it be used and can it be improved? This interactive course will address these questions by -i- going through the main bottlenecks hampering microbial-based protein production, -ii- providing a good understanding of how different microbial expression systems work and should be used, and, -iii- how to implement engineering approaches to improve expression systems for further enhancing production yields.

Choosing and Customizing Microbial Expression Systems for RPP

Jan-Willem de Gier, PhD, Professor, Biochemistry and Biophysics, Stockholm University

Microbial Expression Systems for RPP: The Anatomy Lesson

Alexandros Karyolaimos, PhD, Researcher, Department of Biochemistry & Biophysics, Stockholm University

Learning outcomes:

The course will provide an overview of different microbial expression systems, how they work and are best used.
This knowledge is critical to identify a suitable expression system for a certain application.
After the course attendees will be able to make an informed decision when selecting a microbial-based expression system for a certain application.
This course aims to assist anyone producing recombinant proteins in microbial systems from scientists that are at the bench working in discovery or early development and need to produce a variety of different proteins such drug targets and reagents to bioprocess engineers.

Agenda for the Short Course:

2:00 pm Welcome & Introduction

2:15 pm Microbial Expression Systems for RPP: The Anatomy Lesson Taught by Alexandros Karyolaimos

3:30 pm Q&A with attendees

3:15 pm Refreshment Break

3:30 pm Choosing and Customizing Microbial Expression Systems for RPP Taught by Jan-Willem de Gier

4:45 pm Q&A with attendees

5:00 pm Close of Short Course

INSTRUCTOR BIOGRAPHIES:

Jan-Willem de Gier, PhD, Professor, Biochemistry and Biophysics, Stockholm University

Jan-Willem de Gier is Professor of Biochemistry at Stockholm University. Main interest of his laboratory is the creation of E. coli recombinant protein production strains. To this end, both evolutionary and engineering approaches are used. In addition, he is Co-Founder of the biotechnology companies, Xbrane Biopharma AB and Abera Bioscience AB.

Alexandros Karyolaimos, PhD, Researcher, Department of Biochemistry & Biophysics, Stockholm University

Alexandros is a researcher working at the department of Biochemistry and Biophysics, Stockholm University. Since his Ph.D. and through-out his post-doc, Alexandros has focused on answering fundamental questions regarding protein quality control in the cell envelope of E. coli and how to use this information to enhance recombinant protein production. Part of his work is directed to identifying and solving the bottlenecks hampering protein production in E. coli and has resulted in the development of an easy-to-use and accessible platform to customize E. coli for protein production. Currently, the stage is being set to commercialize the platform.

SC3: In silico and Machine Learning Tools for Antibody Design and Developability Predictions

Given the exciting pace in the evolution of machine learning tools towards antibody design and developability predictions, we plan to present an overview in this field specificity geared towards antibody design and developability predictions. There will be a live demo as well of few ML tools.

Instructors:

Vinodh B. Kurella, PhD, Biotherapeutic Computational Modeler, Takeda Pharmaceuticals, Inc.

Tony Pham, Scientist, Biologics Engineering & Developability, AstraZeneca

Nele Quast, DPhil Candidate, Oxford Protein Informatics Group

Topics to be covered include:

Overview of Sequence, Structure-guided, ML (machine learning) tools for developability and designs

In-silico developability assessment and analyses of diverse sequences from diverse public sources (NGS, clinical)

Summary of high throughput experimental developability assessment.

In-silico structural feature generation

Overview and demo of various ML tools from Oxford Protein Informatics Group (OPIG) and others such as Rosetta based Protein MPNN and RF (RosettaFold) Diffusion models.

Antibody specific language models (Ablang - Olsen et al 2022, Ablang2 - Olsen et al 2024)

Antibody (and nanobody) structure prediction (ABodyBuilder2) Abanades et al 2023)

Therapeutic antibody profiling and developability evaluation (TAP - Raybould et al 2019, TAP2 - Raybould et al 2024)

Antibody sequence optimisation with inverse folding (AntiFold - Hummer et al 2023)

INSTRUCTOR BIOGRAPHIES:

Vinodh B. Kurella, PhD, Biotherapeutic Computational Modeler, Takeda Pharmaceuticals, Inc.

Vinodh Kurella is a Senior Scientist (Biologics computational modeler) in Biotherapeutic Engineering Group (BE) within Global Biologics at Takeda (Cambridge, USA). Experienced in structure-based antibody/protein design and optimization. Previously had range experiences at various biotech companies in different modalities such as gene therapy, biologics, and CAR T designs. Post-doctoral training at Harvard Medical School/Dana Farber in Dr. Wayne Marasco laboratory in antibody engineering and graduate training from Louisiana State University (LSU-HSC) in the field of protein X-ray crystallography in David Worthylake laboratory.

Tony Pham, Scientist, Biologics Engineering & Developability, AstraZeneca

At AstraZeneca’s Department of Biologics Engineering (Gaithersburg, MD), Tony Pham works on establishing new high-throughput experimental methods for developability assessment to support early-stage lead identification. With a background in biochemistry, computational biology, and data analytics he also works on implementing new in silico methods to predict developability properties of antibodies. Specific interests include developability of novel formats such as VHHs, ensemble-based structural analysis, and molecular dynamics. He studied biotechnology, earning his master’s degree at Boston University.

Nele Quast, DPhil Candidate, Oxford Protein Informatics Group

As a PhD student in the Oxford Protein Informatics Group (OPIG) Nele Quast develops and trains deep learning models for immune protein structures, supervised by Dr Matthew Raybould and Prof Charlotte Deane. Nele is interested in architectures that retain equivariance, merge sequence and structure information and can be injected with conditions or constraints. Specifically, her current research investigates T-cell receptor structures and their interface with peptide MHC antigen. As a researcher in OPIG she develops and uses the OPIG software suite, particularly ImmuneBuilder (Abanades et. al.) and various databases such as the Structural Antibody, Structural TCR and Observed Antibody Space databases. Previously Nele obtained a Masters degree in bioengineering at Imperial College London and worked in industry as a machine learning software developer.

SC4: Safety and Efficacy of Bispecifics and ADCs

Bispecific immunotherapies and ADCs are the two most rapidly advancing cancer therapeutics in the war against cancer. However, efficacy and safety challenges limit their therapeutic effectiveness in resistant and refractory cancers. The short course will discuss the translational aspects of bispecifics and ADCs; efficacy and safety challenges originating from poorly constructed ADCs; five rights of the targets, effector arms, and constructs for attaining the best therapeutic index for bispecifics and ADCs as well as strategies to minimize toxicities of bispecific and ADCs.

2:00 pm

Safety and Efficacy of Bispecifics and ADCs

Rakesh Dixit, PhD, President & CEO, Bionavigen

Bispecific and ADC landscape assessment and unmet medical needs
Efficacy and safety challenges originating from poorly constructed ADCs
Five rights of the targets, effector arms, and constructs for attaining the best therapeutic index for bispecifics and ADCs
Minimizing toxicities of bispecifics and ADCs
Translational aspects of bispecific and ADC development

INSTRUCTOR BIOGRAPHIES:

Rakesh Dixit, PhD, President & CEO, Bionavigen

Rakesh Dixit is an accomplished executive, inventor, and scientist with over 35 years of success with top biotechnology and pharmaceutical companies, including Merck, Johnson & Johnson, and Medimmune - AstraZeneca. Currently, he is President and CSO of Regio Biosciences and Bionavigen, LLC. He is a Board Member of Regio Biosciences and a key member of multiple scientific advisory boards. Rakesh is also a chief adviser and consultant for more than 20 companies worldwide. His biopharmaceutical peers selected Rakesh as one of the 100 Most Inspiring People in the Pharmaceutical Industry by PharmaVOICE in 2015. Rakesh received the Most Prestigious Award of Long-Standing Contribution to ADCs by World ADC (Hanson-Wade), 2020. From 2006 to 2019, Rakesh was a Global Vice President of the Biologics R&D at Medimmune - AstraZeneca. Rakesh has unique expertise in developing biologics (e.g., monoclonal antibodies, bispecific biologics, antibody-drug conjugates, fusion proteins, peptides, gene and cell therapies, etc.) and small-molecule biopharmaceuticals. His areas of expertise include discovery, early and late preclinical development, safety assessment, DMPK, and translational sciences. Dr. Dixit conducted extensive graduate and post-graduate training in Pharmacology/Toxicology-Biochemistry with both Indian and USA Institutions (e.g., Case Western Reserve University, Medical College of Ohio, University of Nebraska) and is a Diplomate and Board Certified in Toxicology from the American Board of Toxicology, Inc. since 1992.

SC5: Targeting Solid Tumors and Understanding the TME

The tumor microenvironment (TME) can significantly impact the efficacy of cancer treatments, especially against solid tumors. Solid tumors are typically surrounded by a dense network of stromal cells, blood vessels, and extracellular matrix, which can create a barrier to the delivery of drugs and other therapies. This short course discusses the latest immunology, strategies and targets driving solid tumor cancer therapies.

2:00 pm

Targeting Solid Tumors and Understanding the TME

Tony R. Arulanandam, DVM, PhD, Senior Vice President and Head R&D, Cytovia Therapeutics

Understanding the Tumor Microenvironment (TME)
TME's role in immuno-oncology
Solid tumor biology
Targeting solid tumors
Latest approaches to solid tumors

INSTRUCTOR BIOGRAPHIES:

Tony R. Arulanandam, DVM, PhD, Senior Vice President and Head R&D, Cytovia Therapeutics

Tony Arulanandam, DVM, PhD, Senior Vice President and Head of Preclinical Research and Development at Cytovia Therapeutics focused in developing NK Cell engager bispecific antibody and iPSC derived CAR-NK therapies for cancer. He is also the Co-Founder of NextPoint therapeutics, an MPM capital-funded IO checkpoint immunotherapy company. He is an immunologist with 20+ years of research and development experience developing multiple immunotherapies for autoimmune/inflammatory diseases and cancer (5 BLAs and multiple INDs). He is also currently a mentor for postdocs at the Dana-Farber Cancer Institute through the post-graduate association.

2024年5月14日（二） 6:30 - 9:00 pm

SC6: Best Practices for Targeting GPCRs, Ion Channels, and Transporters with Monoclonal Antibodies

Complex membrane proteins represent the majority of protein classes addressed by therapeutic drugs. Significant opportunities exist for targeting complex membrane proteins with antibodies, but it has been challenging. This course will examine emerging technologies and strategies for enabling the successful isolation of specific and functional antibodies against GPCRs, ion channels, and transporters, and highlight progress via case studies.

6:30 pm

Best Practices for Targeting GPCRs, Ion Channels, and Transporters with Monoclonal Antibodies

Ross Chambers, PhD, Vice President, Antibody Discovery, Integral Molecular, Inc.

Topics to be Covered:

Overview of different classes of membrane proteins, including structure, mechanism, and their role in disease
Membrane protein biochemistry and antigen preparation strategies
Use of mRNA and DNA for eliciting immune responses against membrane proteins
Antibody discovery and methods to enable isolation of functional antibodies
Review of mechanisms relevant to complex membrane proteins (GPCRs, ion channels, transporters), in vitro assays for measuring the detailed binding and function of antibodies
Review of promising membrane protein targets and antibodies in development

INSTRUCTOR BIOGRAPHIES:

Ross Chambers, PhD, Vice President, Antibody Discovery, Integral Molecular, Inc.

Ross Chambers is the Vice President of Antibody Discovery at Integral Molecular. He pioneered the use of DNA immunization for antibody production and developed Integral Molecular’s MPS system for isolating antibodies. Dr. Chambers earned his PhD from the University of Otago, New Zealand, and did post-doctoral studies at UC Davis and Berkeley. Before joining Integral Molecular, he was the Director of R&D at SDIX and directed the discovery of thousands of commercial antibodies.

SC7: The Use and Optimization of Eukaryotic Expression Systems to Support Therapeutic Generation and Structural Biology

The choice of a suitable eukaryotic expression system depends mainly on the biological and biochemical properties of an individual protein. The course will focus on insect and mammalian expression systems, which have demonstrated the ability to express complex proteins for a wide variety of applications. We will discuss the concepts, uses, and optimization of these systems. The course combines instruction and case studies in an interactive environment.

Implementing and Optimizing Eukaryotic Expression Workflows

Richard Altman, MS, Field Application Scientist, Life Science Solutions, Thermo Fisher Scientific

This presentation will describe protein expression laboratory challenges and methods to maintain an efficient expression facility. We will explore expression workflow optimization and then take a step back to first identify bottlenecks and then examine opportunities to increase workflow efficiency in the entire CEPA (Cloning, Expression, Purification, and Analytics) process. We will also share experimental troubleshooting lessons learned in this interactive session.

Transient Protein Production in Mammalian Cells

Henry C. Chiou, PhD, Senior Director General Manager, Biosciences, Thermo Fisher Scientific

Mammalian transient expression based on HEK293 or CHO cells are mainstay tools for rapid production of recombinant proteins for biotherapeutic drug development, production of recombinant viruses, viral vectors for CGT, and basic research. We will discuss key principles for optimizing and maintaining consistency of mammalian transient expression systems. We will also discuss best practices in scaling-out and -up these systems and considerations when expressing low-yielding proteins.

Producing Recombinant Proteins in Insect Cells

Dominic Esposito, PhD, Director, Protein Sciences, Frederick National Laboratory

In the past decade, insect cell based protein production has become a therapeutically viable system for generation of high-yield and high-quality recombinant proteins. Using a baculovirus vector, insect cell lines can produce well-folded proteins with proper post-translational modifications which have been used for structural biology, drug discovery, and recombinant protein or VLP vaccines. We will explore the basic processes needed to generate proteins in insect cells with attention to the molecular biology needed to generate baculovirus constructs, the options for optimization and small-scale screening, and technology developments to improve the production of challenging targets including multiprotein complexes.

Agenda

6:15: Dinner Buffet Served

6:25: Welcome Remarks Richard Altman, MS

6:30: Transient Protein Production in Mammalian Cells Henry C. Chiou, PhD

7:05: Producing Recombinant Proteins in Insect Cells Dominic Esposito, PhD

7:40: Dessert Break

7:55: Implementing and Optimizing Eukaryotic Expression Workflows Richard Altman, MS

8:30: Q& A and Wrap-up Discussion

INSTRUCTOR BIOGRAPHIES:

Richard Altman, MS, Field Application Scientist, Life Science Solutions, Thermo Fisher Scientific

Rich Altman has 30 years of experience in protein expression and production. In early 2019, he joined Thermo Fisher Scientific as a Field Application Scientist. Previously, he worked for several pharmaceutical companies, including Amgen, Alexion, Bayer, and Upjohn, on the cloning, expression, purification and characterization of recombinant proteins. This work supported both small-molecule high-throughput screening and protein therapeutic efforts. He received his MS degree from the University of Pittsburgh School of Medicine in the Department of Molecular Biology and Biochemistry.

Henry C. Chiou, PhD, Senior Director General Manager, Biosciences, Thermo Fisher Scientific

Henry Chiou is Senior Director and General Manager for the Delivery and Protein Expression business within Biosciences at Thermo Fisher Scientific. He and his teams have developed products such as the Expi family of 293, CHO and Sf9-based expression systems, Lipofectamine 3000, and other Lipofectamine-family transfection reagents, production systems for cell and gene therapy viral vectors such as AAV MAX system. Henry has authored multiple publications on mammalian transient expression and frequently teaches courses and lectures on this subject. Prior to joining Thermo Fisher, Henry worked in small to mid-sized biotech companies on non-viral gene therapy. Henry received his doctorate from Harvard University in Molecular Pharmacology, following which he completed a postdoctoral fellowship in viral expression systems at the University of Pennsylvania.

Dominic Esposito, PhD, Director, Protein Sciences, Frederick National Laboratory

Dr. Esposito is currently the Director of the Protein Expression Laboratory (PEL) and Project Lead for the RAS Reagents Core at the Frederick National Laboratory for Cancer Research in Frederick, Maryland. The 38 employees in the PEL clone, express, and purify proteins from a variety of host organisms in support of the NCI RAS Initiative and for investigators at the National Institutes of Health. In addition, the PEL invents and develops novel technologies for improving protein expression and production, focused heavily on baculovirus expression technology and combinatorial cloning. Prior to his role as director, Dr. Esposito led the Clone Optimization Group in the PEL for nine years and was responsible for the generation of over 15,000 expression clones, 400 new expression vectors, and several technological innovations in protein expression. Dr. Esposito received his B.A. in Chemistry at La Salle University in Philadelphia, and his Ph.D. in Biochemistry in the laboratory of Dr. John Scocca at the Johns Hopkins University Bloomberg School where he studied bacteriophage site-specific recombination. Dr. Esposito then worked as a postdoctoral fellow in the laboratory of Dr. Robert Craigie at the NIDDK, where he studied the protein-DNA interactions involved in the HIV integration reaction. Prior to joining the FNL in 2001, Dr. Esposito worked for three years as a Staff Scientist in the Protein Engineering group at Life Technologies, where he helped to develop the Gateway recombinational cloning system. Dr. Esposito has published over 100 peer-reviewed manuscripts in the fields of protein expression and DNA recombination.

SC8: Developability of Bispecific Antibodies

Bispecific antibodies are a rapidly growing and clinically validated class of antibodies with marketed drugs and multiple candidates in clinical trials. Targeting multiple antigens in a synergistic manner can confer enhanced therapeutic benefit and potentially uncover novel biological mechanisms. However, multiple formats and a tedious candidate selection process to select functional and developable bispecific antibodies makes such programs cumbersome. This short course highlights the rapid growth in the field, therapeutic applications, and focuses on challenges with discovery and development of bispecific antibodies. We will use an approved bispecific antibody as a case study to understand the varied aspects of discovery and development of bispecific antibody programs

6:30 pm

Developability of Bispecific Antibodies: Formats and Applications

Nimish Gera, PhD, Vice President, Biologics, Mythic Therapeutics

Topics to be covered

Introduction to bispecifics and bispecific formats

Therapeutic applications of bispecific antibodies

Developability of bispecifics

Case study: discovery and development of an FDA-approved bispecific antibody

INSTRUCTOR BIOGRAPHIES:

Nimish Gera, PhD, Vice President, Biologics, Mythic Therapeutics

Nimish Gera is the Vice President of Biologics at Mythic Therapeutics leading multiple projects to engineer and develop novel antibody and antibody-based drugs in oncology and immuno-oncology. Prior to Mythic, Nimish has over fifteen years of experience in antibody and protein engineering with five years leading bispecific antibody programs in several disease areas such as rare diseases, oncology, and immunology at Alexion Pharmaceuticals and Oncobiologics. Nimish received his PhD degree in Chemical and Biomolecular Engineering from North Carolina State University and a B.Tech degree in Chemical Engineering from Indian Institute of Technology, Guwahati.

* 活動內容有可能不事先告知作更動及調整。

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