09:00 - 12:00 | MORNING
SC1: Advanced Introductory Course on Making Antibody Libraries in Phage and Yeast
( ショートコース1：ファージディスプレイと酵母ディスプレイでの抗体ライブラリー作製に関する基礎講座 )
Andrew R.M. Bradbury, MB BS, PhD, CSO, Specifica, Inc.
This course will provide an advanced introduction to antibody engineering. Students will learn about antibody background, including structure, genetics and the generation of diversity, as well as the creation of naïve antibody libraries in the phage and yeast display formats. This will include a description of phage and yeast display technologies, the creation of naïve libraries from natural and synthetic sources, and the use of next-generation sequencing. The seminar will be fully interactive with students provided ample opportunities to discuss technology with the instructor.
SC2: The Tumour Microenvironment and Response to Cancer Immunotherapy
( ショートコース2：腫瘍微小環境とがん免疫療法への反応 )
Stephen Beers, PhD, Professor, Immunology and Immunotherapy, Centre for Cancer Immunology, Cancer Sciences Unit, University of Southampton
Björn Frendéus, PhD, CSO, BioInvent International AB
The tumour microenvironment (TME) is a complex, dynamic environment containing tumour cells, extracellular matrix (ECM), cytokines, immune cells, and stromal cells. These cell populations interact and influence each other to help the tumour grow and suppress immune responses. As well as propagating tumour growth and spread, the TME may also influence the response to immunotherapy. In this short course we will discuss the nature of the TME and the multiple ways in which it promotes an immunosuppressive environment. Opportunities to alter the TME in order to more effectively deliver immunotherapy will also be discussed. Finally, we will present and discuss emerging therapeutic approaches and consider how they might be used to enhance patient outcomes.
SC3: Mutation and Selection Strategies beyond Affinity Optimisation
( ショートコース3：親和性最適化以外の分野における変異と選択の戦略 )
Orla Cunningham, PhD, Senior Director, BioMedicine Design, Pfizer
Jonny Finlay, PhD, CEO, Ultrahuman
In therapeutic antibody discovery, few lead molecules meet all the demands required of a truly manufacturable drug. Most lead candidates require some form of engineering and optimization. This course will begin with an introduction to the multiple display technology platforms, mutagenesis strategies and library generation options that exist to enable antibody optimization. In the simplest application, generated libraries can be selected for improved antigen binding. However, increasingly these strategies are being used for more complex applications from humanization to ortholog cross-reactivity, stability, solubility and specificity optimizations. This workshop will use case studies to help attendees navigate the complex workflows and technological options available to ensure success.
SC4: Surfactants in Biotherapeutics: Can’t Live with Them, Can’t Live without Them
( ショートコース4：生物学的製剤のなかの界面活性剤：共存不能だが、不可欠な存在 )
Atanas Koulov, PhD, Head, Drug Product Analytical Development and Quality Control, Drug Product Services, Lonza Pharma and Biotech
Hanns-Christian Mahler, PhD, Head, Drug Product Services, Lonza Pharma and Biotech
Additional Instructor to be Announced
Surfactants are excipients critical to the stability of most biopharmaceutical parenteral formulations. They stabilize proteins in solutions by mitigating potential adsorption and interfacial stress-induced aggregation or precipitation encountered during many stages of production, shipment and use. The most commonly used surfactants are the non-ionic excipients, Polysorbate 20 and 80. However, the use of these surfactants can also lead to a number of liabilities related to stability (of the surfactant and of the active protein) as well as potential for pseudoallergenic reactions. Regulatory authorities are therefore also paying increasing attention to this critical excipient. This workshop will provide a complete perspective on the use and control of polysorbates in biotherapeutic products.
SC5: Use and Troubleshooting of Eukaryotic Expression Systems
( ショートコース5：真核生物の発現系の利用とトラブルシューティング )
Richard Altman, MS, Field Application Scientist, Protein Expression, Biosciences Division, Life Sciences Solutions Group, Thermo Fisher Scientific
Henry C. Chiou, PhD, Director, Cell Biology, Life Science Solutions, Thermo Fisher Scientific
Dominic Esposito, PhD, Director, Protein Expression Laboratory, Frederick National Laboratory for Cancer Research
Eukaryotic expression systems are extensively used for the generation of recombinant proteins thereby becoming an essential protein engineering tool. 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 both the 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 along with sharing experimental troubleshooting lessons learned. The course combines instruction and case studies in an interactive environment.
17:30 - 20:30 | dinner
SC6: Selection, Screening and Engineering for Affinity Reagents
( ショートコース6：親和性試薬の選択、スクリーニング、開発 )
Nathalie George, PhD, Investigator III, NIBR Biologics Center, Discovery Technologies, Novartis Pharma AG
Christoph Erkel, PhD, Associate Director, Discovery Alliances & Technologies, MorphoSys AG
Biologics such as recombinant antibodies and alternative binding scaffolds are routinely used in a wide variety of applications from basic research to clinical indications. This success has led to the development of a vast number of different selection, screening and engineering technologies for these molecules. This short course will give a comprehensive overview on different display technologies as well as screening approaches for the selection of specific binders. In addition, it will discuss engineering strategies including affinity maturation and how to implement these strategies. Classical antibodies and antibody fragments as well alternative binding scaffolds will be covered.
SC7: Protein Aggregation: Mechanism, Characterization and Consequences
( ショートコース7：タンパク質凝集：機構、特性評価、結果 )
Thomas Laue, PhD, Professor Emeritus, Molecular, Cellular and Biomedical Sciences, University of New Hampshire
Speaker to be announced, Malvern Panalytical, Inc.
Protein aggregation is recognized by regulatory agencies and the biopharmaceutical industry as a key quality attribute of biotherapeutics. Various aggregates hold the potential for adversely impacting production and patients in a variety of ways. This in-depth course reviews the origins and consequences of aggregation in biotherapeutics, and then examines strategies for predicting and quantifying aggregation in biopharmaceuticals. It benefits scientists engaged in the development, production, analytical characterization and approval of biotherapeutics and who require a good working knowledge of protein aggregation.
SC8: Advanced Analytical Technologies for Developability and Early Formulation Assessments
( ショートコース8：発展性評価と早期製剤設計評価のための先進的な分析技術 )
Danny K. Chou, PharmD, PhD, President, Compassion BioSolution, LLC
For biopharmaceuticals, drug design, lead selection and formulation/manufacturing process development constitute significant areas of risk because of their decisive influence on product quality, biological activity and safety, as well as cost of goods. The purpose of this short course is to introduce how a range of advanced analytical technologies, along with the concept of Quality by Design (QbD) may be incorporated at the interface of drug discovery and development in order to both select drug candidates with the best inherent stability and deliver the most suitable formulation for these molecules. Part of the course will be focused on the practical tools (both conceptual tools and analytical tools) one can use to achieve this objective.
SC9: T Cell Therapies: Current Field, Challenges and Future Directions
( ショートコース9：T細胞療法：現在の適応領域、課題、今後の方向性 )
Reno Debets, PhD, Associate Professor, Laboratory of Tumor Immunology, PI, Medical Oncology, Erasmus MC-Cancer Institute
The field of Adoptive T cell therapy (AT) is advancing rapidly and with the FDA approval of T cell products expressing CD19-specific Chimeric Antigen Receptor (CAR) to treat B cell leukemias (Kymriah and Yescarta), it has entered a new era. However, significant challenges remain and need to be addressed to keep the momentum. These include safety assessment of target antigen and corresponding CARs or T cell receptors (TCRs), optimisation of T cell fitness, and the search for combinatorial approaches to enable T cells to target solid tumors. In addition to the preclinical trajectory, it is important to roll out these therapies in the clinical setting, which includes steps such as the manufacture and testing of clinical grade vector, development of efficient and reliable manufacturing methods, and delivering the therapies to patients safely, effectively and at a cost that is considered reasonable. This workshop will explore these important issues as we look to transition AT from the laboratory into mainstream medicine.
SC10: Engineering of Bispecific Antibodies and Multi-Specific Non-Antibody Scaffolds
( ショートコース10：二重特異性抗体と多特異性非抗体スキャフォールドの開発 )
Part 1: Engineering of Bispecific Antibodies
( パート1：二重特異性抗体の改変 )
Simon Brack, PhD, Director External Innovation DPDS, Janssen Pharmaceutical Companies of Johnson & Johnson
Over the last decade, the field of bispecific antibodies (BiAbs) has significantly matured. Today, BiAbs represent a clinically validated class of therapeutic molecule as several products have been approved for different therapeutic indications and many others BiAbs are in clinical trials. Protein engineers have been incredibly active and inventive, providing numerous solutions to the fundamental problem of how to effectively combine two antibody specificities into a single molecule. These efforts resulted in the vast array of formats that is currently available. Different BiAb formats have distinct characteristics, supporting the unique modes of action that are enabled by BiAb. Beyond biology and therapeutic activity, manufacturing and stability of these innovative molecules has been and remains an important factor that can limit progression of BiAb towards the clinic.
By attending this interactive workshop, you will learn about the various approaches used for the engineering of bispecific antibodies. Different technologies will be compared and examples for applications of bispecific antibodies in drug development will be presented. Opportunities and challenges in the field of bispecific antibodies will be discussed, highlighting pros and cons of different approaches.
Part 2: Non-Antibody Multi-Functional Scaffolds
( パート2：非抗体多機能スキャフォールド )
Mathieu Cinier, PhD, Scientific Director, Affilogic
Non-antibody scaffolds represent a new class of therapeutic molecules that fill a molecular weight gap between antibodies and peptides. While sharing the high specificity and potency of antibodies, their low molecular weight and simple structure make them amenable to peptide-like properties such as high tissue penetration. They are also easy to assemble, providing a straightforward “plug and play” approach to combine active modules into a single molecule that displays the desired druglike properties. At this age of multi-functional therapeutic molecules, non-antibody scaffolds continue to rise with an increasing number in ongoing clinical phases, making them valuable assets in the landscape of next generation biologics. In this interactive workshop, you will be provided with an overview on existing non-antibody scaffold technologies. Challenges in their development will be discussed together with their pros and cons regarding antibody-based therapeutics. Applications and therapeutic needs that are targeted with non-antibody scaffolds will be also addressed, highlighting the diversity of formats currently in development. Eventually, take home messages will be given over the review of several case studies.
*Separate registration required