トレーニングセミナー | 24th Annual PepTalk 2025: The Protein Science and Production Week 公式サイト

Cambridge Healthtech Instituteのトレーニングセミナーでは、実際のケーススタディ、遭遇した問題、適用された解決策、学術的な理論や背景の広範な説明が提供されます。各トレーニングセミナーでは、学習体験を最大限に高めるために、正式な講義とインタラクティブなディスカッションやアクティビティが組み合わされています。これらのトレーニングセミナーは、経験豊富な講師陣が担当し、現在の研究に応用できる内容に焦点を当てるとともに、各分野の初心者には重要なガイダンスを提供します。

トレーニングセミナーは、対面式でのみ開催予定
一貫性のある集中的な学習環境を確保するため、
会議セッションとトレーニングセミナー間の移動は禁止されています。

2025年1月14日（火） 8:30 am - 6:30 pm | 2025年1月15日（水） 8:30 - 11:00 am

TS5B: Introduction to Antibody Engineering
抗体エンジニアリング入門

In this training seminar, students will learn about antibody basics, including structure, genetics, and the generation of diversity, as well as the generation of potential therapeutic antibodies. This latter part will include antibody humanization, affinity and specificity maturation, display technologies, creation of naive libraries, and antibody characterization. The seminar will be fully interactive with students providing ample opportunities to discuss technology with instructors.

Antibody Background

Structure
Genes
Generation of diversity (recombination, somatic hypermutations)

Antibody Humanization

Closest human gene approach
Minimal modification approach
Veneering

Display Technologies Overview

Phage
Yeast
Combining phage and yeast display
Ribosome
Others

Generation of Naive Antibody Libraries

Natural libraries (methods, quality control)
Synthetic libraries (including strategies for generation diversity)

Affinity Maturation

Error-prone PCR
Chain shuffling
CDR-targeted mutations

Next-Generation Sequencing in Antibody Engineering

Platforms: advantages and disadvantages
Error rates and why they are important
Naive library diversity analysis
Selection analysis

Antibody Characterization and Developability

Expression
Specificity
Aggregation
Solubility

INSTRUCTOR BIOGRAPHIES:

Andrew R.M. Bradbury, MD, PhD, CSO, Specifica, an IQVIA business

Andrew Bradbury is Chief Scientific Officer of Specifica. He trained in medicine at the universities of Oxford and London and received his PhD from the university of Cambridge at the MRC Laboratory of Molecular Biology under the guidance of Nobel Laureate, Cesar Milstein. He has worked in the fields of phage and yeast display, library generation, antibody engineering and Next Generation Sequencing for over thirty years. He was a Group Leader at Los Alamos National Laboratory before founding Specifica. Specifica's mission is to enable companies developing therapeutic antibodies with the world’s best antibody discovery platform.

James D. Marks, MD, PhD

Dr. Marks is Professor and Vice-Chairman of the Department of Anesthesia and Perioperative Care at the University of California, San Francisco (UCSF) and Chief of Performance Excellence at Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG). Dr. Marks received his medical degree from UCSF where he also completed residencies in Internal Medicine and Anesthesia and a fellowship in Critical Care Medicine. He received his Ph.D. in molecular biology from the Medical Research Council Laboratory of Molecular Biology in Cambridge, England. Dr. Marks is an internationally recognized pioneer in the field of antibody engineering, has had constant federal funding for 27 years and has authored more than 200 publications and 100 patents. In recognition of these scholarly achievements, he was elected to the National Academy of Medicine. As an entrepreneur, he has co-founded four biotechnology companies and currently serves on three biotechnology corporate boards.

TS6B: Advanced Purification of Engineered Biologics and Research Protein Tools
エンジニアリングバイオロジクスにおける高度な精製と研究用タンパク質ツール

Nominating engineered biologics lead drug candidates for treating diseases with complex metabolic pathways is a challenging endeavor. This is attributable to a plethora of Achilles heels along the production process for these molecules. The production pitfalls of engineered biologics include immunogenicity, toxicity, poor manufacturability, low potency, long production cycle-time, the high cost of production, and labor intensity. Screening out these detrimental attributes requires production, purification, and characterizing thousands of molecules through a battery of robust low protein consumptive HT-assays. This course presents two high-throughput (HT) “plug-and-play” single-cycle protein purification strategies. From crude cell cultures with cells, the first strategy delivers ample high-quality proteins at low cycle time, cost, and labor intensity for lead nomination. Parallel to the above strategy is a second high-HT pneumatic purification strategy for biologics or tagged protein panels from filtered cell cultures.

Learning points:

Surface chemistry of proteins and their behaviors in aqueous buffers
Protein-monodispersing elements for “sticky” proteins and clearance of low abundance product degrading and destabilizing impurities
Protein aggregates and aggregate clearance strategies
Old semi-automated robots for 24/96-format HT-panel protein purification
A novel hybrid HT-magnetic bead/resin-based purification robot for 6(x50ml), 24(x4ml), and 96(x1ml) formats
Side products clearance from biologics using purification promoting mutations
Protein purification tags and traceless engineering/purification tags for generating mutation-free bispecific molecules
High-speed HT-low protein consumptive analytics for protein panels

Who should attend?

Although this course is directed towards protein purification experts in the fields of biologics and proteomics, biologics engineers and experienced scientists in general protein purification will find it very useful.

INSTRUCTOR BIOGRAPHIES:

John K. Kawooya, PhD, Private Consultant of Robotics-Plate-Based-Ultra-HT Biologics Purification

Director, Biologics Optimization, Discovery Research, Amgen, Inc.; PhD, University of Illinois at Urbana-Champaign; Postdoctoral at the University of Chicago and University of Arizona, Tucson; Visiting Scientist, University of Rio de Janeiro; over 20 years of industrial experience in column protein purification and high-throughput magnetic protein purification technologies.

TS7B: Bridging the Gap from R&D to Bioprocessing
R&Dからバイオプロセシングへの橋渡し

Do you seek to better understand end-to-end operations in drug development; gain clarity of biotech-pharma functions, cross-functional teams, and phase-appropriate analytics; and improve quantitative go/no-go decisions in order to accelerate therapies to patients? This 1.5 day course will focus on discovery & drug development processes and operations-providing an overview of the drug pipeline and key milestones towards IND filings, detailed assessments of cross-functional strategies, and in-depth learnings in R&D spanning therapeutic candidate selection, developability assessments, risks & mitigations, and analytical & process development considerations for regulatory submissions. This interactive course is designed for scientists and engineers in discovery, nonclinical development, and CMC, with a desire to increase the probability of success of therapeutic candidates across multiple modalities (biologics, small molecules, cell and gene therapies). Instructors will share best practices, key pitfalls, translational guidelines, data-driven strategies, and regulatory considerations through case studies, course materials, and supplemental information.

Topics to be covered:

Drug pipeline overview and key milestones towards IND filings
Key elements of therapeutic candidate selection
Developability assessments
Process and analytical and development considerations for regulatory submissions
Regulatory considerations, Quality-by-Design (QbD)
Cross-functional strategies: drug discovery & development data integration, mathematical models, & utility

Who should attend:

Scientists and engineers in discovery, nonclinical development, and CMC, with a desire to facilitate and accelerate successful development of clinical therapeutic candidates across multiple modalities (biologics, small molecules, cell and gene therapies).

INSTRUCTOR BIOGRAPHIES:

Carissa L. Young, PhD, Senior Director, Development Asset Lead, Biogen

Carissa has 18+ years in pharma-biotech spanning nonclinical, CMC, and clinical development across multiple modalities (cell therapies, biologics, small molecules) and disease indications. She has built and managed cross-functional teams in Drug Development and Data Sciences to maximize the value of therapeutic pipelines, portfolio, and platforms. Her versatility enables her to engage across the diversity of translational sciences, process-product development life cycle, clinical/nonclinical study designs to regulatory filings, data quality oversight and compliance. Previous industry experience includes Intellia Therapeutics, Takeda, Applied Biomath, and Johnson & Johnson. Teaching experience as Instructor at Harvard Medical School and the University of Delaware. Carissa received her Chemical Engineer degrees at Georgia Tech (BS) and the University of Delaware (PhD), completing her post-doctoral training in Biological Engineering at MIT.

Marieke Koedood Zhao, PhD, Independent Consultant, Bioprocess Development

Marieke has 20+ years experience in bio-therapeutic development, facilitating collaboration of research, preclinical, CMC, and clinical development teams and had a track record of ushering novel Biologics from pre-development to first-in-human clinical trials with aggressive timelines. She has hands-on experience in drug substance process development, technology transfer, process scale-up, selection and management of Contract Manufacturing Organizations (CMOs), CMC strategy, and regulatory filings for antibody-drug conjugates and mRNA products entering the clinic. Previous industry experience includes Kudo Biotechnology, GreenLight Biosciences, Mersana Therapeutics, ImmunoGen and Wyeth Biopharma. Marieke received her PhD from the University of Zurich in Switzerland and completed post-doctoral training at Boston University.

2025年1月15日（水） 3:15 - 5:50 pm | 2025年1月16日（木） 8:15 am - 4:15 pm

TS5C: Antibody Drug Discovery: From Target to Lead
抗体創薬：ターゲットからリードまで

At least 100 antibody therapies have been approved for the treatment of cancer, immune disorders, metabolic, cardiovascular, and infectious diseases, and among the top 20 bestselling prescription medicines in 2020, 14 are antibody-based. This trend will continue as about 50% of the new drugs in various stages of clinical development are antibodies. This course will review state-of-the-art concepts, methodologies, and current trends in therapeutic antibody discovery and development.

Topics to be covered include:

Different Sources of Antibodies

- Animals: mouse, rat, rabbit, chicken, llama, etc.

- Libraries: immune, synthetic, native, fully human, etc.

- B cells: memory B cells, plasma B cells, human, and animals

Antibody-Based Drug Modalities

- IgGs, IgA, IgM, Bites, nanobody, antibody fragments, etc.

- Naked antibody

-ADC

- Bispecific/multispecific

- CAR T

Antibody Engineering

- Affinity maturation

- Humanization

- Fc-engineering: half-life, immune effector function, etc.

Target Selection and Validation

Antibodies Targeting Complex Membrane Proteins

- GPCRs

- Ion channels

- Transporters and membrane-bound enzymes

Delivery of Antibodies

Crossing the Brain-Blood Barrier (BBB)

Case Studies

INSTRUCTOR BIOGRAPHIES:

Zhiqiang An, PhD, Professor, Robert A. Welch Distinguished University Chair in Chemistry; Director, Texas Therapeutics Institute; Director, CPRIT Core for Antibody Drug Discovery; Vice President, Drug Discovery, University of Texas Health Science Center at Houston

Dr. Zhiqiang An is Professor of Molecular Medicine, the Robert A. Welch Distinguished University Chair in Chemistry, Director of the Texas Therapeutics Institute, and Vice President of Drug Discovery at the University of Texas Health Science Center at Houston. His laboratory focuses on antibody drug resistance mechanisms, biomarkers for therapeutic antibodies, and antibody drug discovery targeting human diseases. During the last five years, more than 12 novel antibody drug leads discovered in his laboratory were licensed to eight biotechnology companies, and six (6) have advanced to clinical trials for diseases ranging from acute myeloid leukemia (IO-202), breast cancer bone metastasis (ALMB-0168), solid tumor (IO-108), spinal cord injury (ALMB-0166), COVID-19 (IGM6268), and solid tumor (PRTH-101). Previously, he served as Chief Scientific Officer at Epitomics, Inc. and was Director of Biologics Research at Merck Research Laboratories. He has authored over 200 journal articles including more than 30 papers in Nature, Science, and Cell journal series; and two books including the award-winning “Therapeutic Monoclonal Antibodies: from Bench to Clinic.” He is an elected fellow of Society for Industrial Microbiology and Biotechnology (SIMB), the American Academy of Microbiology (ASM), American Association for the Advancement of Science (AAAS), and the National Academy of Inventors (NAI). Dr. An received his PhD from the University of Kentucky and his postdoctoral training at the University of Wisconsin-Madison.

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