Cambridge Healthtech Institute (CHI) の研修セミナーは、実際のプロジェクトのケーススタディ、これまでに遭遇した問題と用いられた対策などに加え、学術的理論やその背景となっている研究なども幅広く網羅します。それぞれのセミナーは、講義、双方向の討論、学習効果を高める各種の活動などを組み合わせたものとなっており、個々の専門分野に精通した経験豊富な講師が、現在手掛けている研究に応用可能な知識を提供し、初学者にとって重要な助言を行います。
1月19日(日) | PRE-CONFERENCE REGISTRATION 4:00 - 6:00 PM
1月20日(月) - 1月21日(火)
Day 1: 9:00 am - 6:00 pm | Day 2: 8:45 am - 12:30 pm
TS8A: Protein Aggregation and Formulation Optimization
( タンパク質凝集と処方の最適化 )
Molecular interactions are central to protein discovery, development, and formulation. This training seminar allows a fundamental, but very practical, understanding of protein interactions, solution behavior, aggregate formation, and its application to formulation optimization. Building on a review of central energy concepts, the framework allows a deeper understanding of protein structural stability, interactions with small molecules, surfaces, itself, other proteins, and other macromolecules. A deeper insight is afforded into the binding, solubility, viscosity, detection, and characterization of protein aggregates.
Thomas Laue, PhD, Professor Emeritus, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire
Kevin Mattison, PhD, Principal Scientist, Malvern Pananalytical, Inc.
Matthew Brown, PhD, Applications Manager, Bioscience, Malvern Panalytical, Inc.
TS9A: Introduction to Antibody Engineering
( 抗体工学入門 )
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 naïve libraries, and antibody characterization. The seminar will be fully interactive, providing students with ample opportunities to discuss technology with instructors.
Andrew R.M. Bradbury, MB BS, PhD, CSO, Specifica, Inc.
James D. Marks, MD, PhD, Chief of Performance Excellence, Zuckerberg San Francisco General Hospital and Trauma Center; Professor of Anesthesia, UCSF Department of Anesthesia and Perioperative Care
1月21日(火) - 1月22日(水)
Day 1: 2:00 - 5:30 pm | Day 2: 8:15 am - 6:05 pm
TS8B: Next-Generation Approaches to Antibody Screening and Discovery
( 抗体のスクリーニングと創薬のための次世代の手法 )
Over the space of a few years, DNA sequencing and data analysis, DNA synthesis, single-cell isolation, and genome engineering using CRISPR/Cas9 have improved greatly in both capability and affordability, and have now been adapted to enhance the discovery and development of antibodies and other immunotherapies. This training seminar will evaluate these new developments and their applications in antibody and immunotherapy discovery and development.
David Bramhill, PhD, Founder, Bramhill Biological Consulting, LLC
TS9B: GMP and Validation Requirements for Biologics Processes – Phase I through to Commercial Manufacturing
( 生物製剤のプロセスに対応するGMPとバリデーションの要件−第1相臨床試験から商業生産へ )
This seminar looks at the current requirements and expectations for GMP manufacturing and testing at all stages of the product lifecycle from Phase I through all clinical phases to commercial manufacturing and maintaining validated status. It will cover phase-appropriate GMP and the evolution of the pharmaceutical quality system to address the requirements at different phases of development and of the commercial product lifecycle. It will also look at how the challenges can vary for different types of biological products. Topics covered will include the regulatory background, process and analytical development, process knowledge, and the impact of single-use systems, process qualification, continuous process verification, and specific considerations for challenging and/or unusual processes, including live vaccines and cell therapy products.
Trevor Deeks, PhD, QA/QC and GMP Consultant, Deeks Pharmaceutical Consulting Services, LLC
1月23日(木) - 1月24日(金)
Day 1: 8:10 am - 5:15 pm | Day 2: 9:00 am - 12:30 pm
TS7C: Introduction to Analytical Characterization and Method Validation for Protein Therapeutic Drugs
( タンパク質治療薬のための解析評価とメソッドバリデーション入門 )
This seminar will review analytical method development and validation in the context of IND regulatory filing of therapeutic proteins, including monoclonal antibodies and recombinant proteins. The curriculum will provide a broad overview of biologics analytical and characterization methods and is beneficial to individuals involved in biologics drug development, analytical development, quality control, quality assurance, regulatory affairs, project management, process development, formulation development, or related functional areas. Attendees will learn the practical aspects of the commonly used analytical panel not only for DS/DP release and stability but also for monitoring the manufacturing process and facilitating formulation development. New real-world case studies and common pitfalls will be presented.
Kevin Zen, PhD, Executive Director, Analytical Characterization, Formulation Development and Biologics Manufacturing, AnaptysBio Inc.
What is a Training Seminar?
Each CHI Training Seminar offers 1.5 days of instruction with start and stop times for each day shown above and on the Event-at-a-Glance published in the onsite Program & Event Guide. Training Seminars will include morning and afternoon refreshment breaks, as applicable, and lunch will be provided to all registered attendees on the full day of the class.
Each person registered specifically for the Training Seminar will be provided with a hard copy handbook for the seminar in which they are registered. A limited number of additional handbooks will be available for other delegates who wish to attend the seminar, but after these have been distributed, no additional books will be available.
Though CHI encourages track hopping between conference programs, we ask that Training Seminars not be disturbed once they have begun. In the interest of maintaining the highest quality learning environment for Training Seminar attendees, and because seminars are conducted differently than conference programming, we ask that attendees commit to attending the entire program, and not engage in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.