2017年11月13日(月) 9:00 - 12:00 | 午前のショートコース
Mark Cragg, Ph.D., Professor, Experimental Cancer Research, Antibody & Vaccine Group, Cancer Sciences, University of Southampton
Fred Arce Vargas, Ph.D., University College London Cancer Institute
Recently, a number of different approaches have demonstrated unprecedented clinical responses and long-term benefit in patients diagnosed with several types of malignancy. In addition to T-cell modulation and anti-PD-1 and anti-CTLA-4, additional pathways and therapeutic agents are rapidly being translated to clinical practice alone or in combination approaches.
Orla Cunningham, Ph.D., Director, Global Biotherapeutic Technologies, Pfizer, Inc.
Matthew Lambert, Ph.D., Principal Scientist, Global Biotherapeutic Technologies, Pfizer, Inc.
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.
Richard Altman, MS, Scientist V, Protein Technologies, Amgen
Henry C. Chiou, Ph.D., Associate Director, Cell Biology, Life Science Solutions, Thermo Fisher Scientific
Dominic Esposito, Ph.D., Director, Protein Expression Laboratory, Frederick National Laboratory for Cancer Research
This short course introduces both the fundamental concepts and technologies needed to establish transient protein production in mammalian cells, which has become an essential tool to enable rapid protein engineering. Transient expression allows for the rapid generation, purification and characterization of milligram-to-gram quantities of secreted or intracellular recombinant proteins for therapeutic, functional and structural studies. The course combines instruction and case studies in an interactive environment.
SC5: 製品とプロセスの開発を改善するための多属性法 (MAM)
Richard Rogers, Ph.D., Scientist 4, Just Biotherapeutics
The course offers hands on training on how to apply the Multi-Attribute Method (MAM) to mass spectrometry data. We will be performing attribute analytics (quantifying product quality attributes) and new peak detection (purity test) on mass spec data. During the course we will discuss the uses of the MAM in process development and in a QC lab.
2017年11月16日(木)17:30 - 20:30 | ディナーショートコース
Nicolas Fischer, Ph.D., Head, Research, Novimmune SA
Michela Silacci, Ph.D., Director, Discovery Research, Covagen AG, part of Johnson & Johnson
You will learn about approaches for engineering bispecific antibodies and bispecific scaffold-based binding proteins. Different technologies will be compared, and examples for applications of bispecific antibodies in drug development will be presented with a focus on candidates currently being evaluated in clinical trials. Opportunities and challenges will be discussed.
Mario Lebendiker, Ph.D., Head, Protein Purification Facility, Wolfson Center for Applied Structural Biology, Hebrew University
This course will provide a comprehensive and detailed outline of hands-on issues for purifying proteins. First we will address considerations about the protein we want to produce, including issues of activity, solubility, homogeneity, purity, and proper oligomeric conformation. In addition, we will address ways to monitor and avoid aggregation, as well as how to set up protein concentration and storage.
Jonas Schaefer, Ph.D., Head, High-Throughput Binder Selection Facility, Biochemistry, University of Zurich
Julia Neugebauer, Ph.D., Associate Director, MorphoSys AG
A comprehensive overview of 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 as alternative binding scaffolds such as DARPins will be covered.
SC9: タンパク質凝集：機序、特性化 結果
Thomas Laue, Ph.D., Professor, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire
Protein aggregation is recognized by regulatory agencies and the biopharmaceutical industry as a key quality attribute of biotherapeutic products. Various aggregates hold the potential for adversely impacting production and patients in a variety of ways. This in-depth workshop reviews the origins and consequences of aggregation in biotherapeutics, and then examines strategies for predicting and quantifying aggregation in biopharmaceuticals.
Hans-Martin Mueller, Ph.D., Director, BioProcess Development, Biologics and Vaccines, MSD Merck
David Wylie, Ph.D., Principal Scientist, Sterile Process and Analytical Development, Merck Research Labs
For a proper planning of novel or biosimilar development programs, it is important to understand the development costs, timelines and the authoring of CMC regulatory sections. The analytical characterization of comparability and similarity studies will form the cornerstone for each successful marketing authorization application of these products. This short course discusses analytical development and its challenges, technical hurdles, BLA authoring, timelines and costs.
*separate registration required for short courses