Cambridge Healthtech Training Seminars offer real-life case studies, problems encountered and solutions applied, and extensive coverage of the basic science underlying each topic. Experienced Training Seminar instructors offer a mix of formal lectures, interactive discussions and activities to help attendees maximize their learning experiences. These immersive trainings will be of value to scientists from industry and academic research groups who are entering new fields - and to those working in supporting roles that will benefit from an in-depth briefing on a specific aspect of the industry.
MONDAY, JANUARY 8 - TUESDAY, JANUARY 9
DAY 1 - 9:00 AM - 6:00 PM | DAY 2 - 8:30 AM - 12:30 PM
TS8A: Introduction to Bioprocessing
CHI's Introduction to Bioprocessing training seminar offers a comprehensive survey of the steps needed to produce today's complex biopharmaceuticals, from early development through commercial. The seminar steps through the stages of bioprocessing, beginning with cell line development and ending at scaling up for commercial production. The seminar also explores emerging process technologies, facility design considerations and the regulatory and quality standards that govern our industry throughout development. The important roles of analytical methods and formulation development are also examined. The class is directed to attendees working in any aspect of industry, including scientific, technical, business, marketing or support functions, who would benefit from a detailed overview of this field.
Sheila G. Magil, Ph.D., Senior Consultant, BioProcess Technology Consultants, Inc.
Frank J. Riske, Ph.D., Senior Consultant, BioProcess Technology Consultants, Inc.
TS9A: Introduction to Antibody Engineering
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 provided ample opportunities to discuss technology with instructors.
Andrew M. Bradbury, Ph.D., MB, CSO, Specifica, Inc.
James D. Marks, M.D., Ph.D., Chief of Staff, Chief of Anesthesia, San Francisco General Hospital; Professor & Vice Chairman of Anesthesia, University of California, San Francisco
TS10A: Introduction to Cell Culture
The seminar will describe the basic requirements for establishing and maintaining mammalian cell cultures both in the laboratory and in large-scale operations. The objective of the seminar is to provide detailed information of the scientific principles behind the use of mammalian cell culture techniques at either a laboratory scale or at a large scale for the production of biopharmaceuticals, which include monoclonal antibodies, recombinant proteins, viral vaccines as well as cell-based therapies. Some attention will also be given to the quality of the increasing list of biopharmaceuticals that have been licensed and are in large-scale manufacture.
Michael Butler, Ph.D., CSO, National Institute of Bioprocessing Research & Training (NIBRT), Ireland
TUESDAY, JANUARY 9 - WEDNESDAY, JANUARY 10
DAY 1 - 2:00 - 5:30 PM | DAY 2 - 8:30 AM - 5:30 PM
TS3B: Next-Generation Approaches to Antibody Screening and Discovery - Detailed Agenda
Over the space of a few years, a series of technologies have improved greatly in both capability and affordability, and have been adapted to enhance the discovery and development of antibodies and other immunotherapies. Among these technologies, DNA sequencing and data analysis, DNA synthesis, single-cell isolation, and genome engineering using CRISPR/Cas9 combine to give significant advances in how we can engineer antibodies and cell lines. This training seminar will evaluate these new developments and their applications in antibody and immunotherapy discovery and development.
David Bramhill, Ph.D., Founder, Bramhill Biological Consulting, LLC
TS10B: Introduction to Biologics Formulation Development
CHI's Introduction to Biologics Formulation Development training seminar focuses on strategies to plan and execute preformulation and formulation development studies for biologics. The seminar begins with an overview of biophysical and biochemical properties of proteins and protein structure, setting the stage for the concepts and goals at the core of protein formulation. The seminar then continues with an exploration into the theory and application of the relevant analytical and biophysical techniques that support preformulation and formulation development studies. The seminar provides an in-depth discussion of typical formulation development workflows, including statistical analysis and use of DoE, and an examination of real-world case studies.
Donald E. Kerkow, Ph.D., Associate Director, Biopharmaceutical Development, KBI Biopharma, Inc.
TS11B: Introduction to Biologics Analytical Development and Characterization
This training 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 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 commonly used analytical panel not only for DS/DP release and stability but also for monitoring manufacturing process and facilitating formulation development: product purity and impurity analysis, product strength and potency, plus matrix verification of the most common process-related impurities. The characterization panel specifically emphasizes structure elucidation by mass spectroscopy, posttranslational modification, biophysical characterization of higher order structure (HOS), and protein aggregates. Real-world case studies and common pitfalls will be presented.
Kevin Zen, Ph.D., Senior Director, Analytical Development, CMC Biologics, AnaptysBio, Inc.
THURSDAY, JANUARY 11 - FRIDAY, JANUARY 12
DAY 1 - 8:15 AM - 5:45 PM | DAY 2 - 8:00 AM - 12:45 PM
TS3C: Introduction to Immunogenicity
All protein drugs generate an immunogenic response. This 1.5-day training seminar provides a practical, comprehensive overview of immunogenicity - the causes, how to assess, predict and prevent, and what to do if you observe immunogenicity during preclinical, clinical and post-market approval. The seminar begins by detailing the science behind immunogenicity, the latest international Guidances, followed by assay and bioanalytical assessment strategies for traditional and emerging biologics. Other topics include predictive models and how to report immunogenicity incidents both internally and externally.
Arno Kromminga, Ph.D., Member, European Immunogenicity Platform, Senior Vice President and European CSO, BioAgilytix
TS9C: Basic Technologies in a Protein Production Lab
This seminar introduces basic technologies, strategies and considerations in recombinant protein expression and purification in E. coli, insect and mammalian cells for multiple research and development applications. It supplies a basic toolbox for management of multiple and diverse projects. It also addresses common problems when translating academic ideas and IP to biotech startup companies, how to avoid those problems, and how to better facilitate this translation, focusing on protein production processes.
Tsafi Danieli, Ph.D., Director, BioGiv Excubator & Head, Protein Expression Facility, Wolfson Centre for Applied Structural Biology, Alexander Silberman Institute of Life Sciences, The Hebrew University of Jerusalem
Mario Lebendiker, Ph.D., Head, Protein Purification Facility, Wolfson Centre for Applied Structural Biology, Alexander Silberman Institute of Life Sciences, The Hebrew University of Jerusalem
TS10C: Managing Risks Associated with Manufacture, Storage and Delivery of Traditional and Novel Biotherapeutics
This training seminar will provide a background on the sensitivities of various modalities such as therapeutic proteins, stem cells and gene therapies in conjunction with the materials used in the manufacture, storage and delivery to patients. There are performance expectations for systems in contact with biologics and each component should be considered based on the unique characteristics of diverse modalities and intended use. At this seminar, you will learn about identification and evaluation of risks related to particulates, container closure integrity, functional performance and leachables/extractables. This knowledge will put the current regulations into perspective and provide a basis for applying science and risk-based approaches into the biologic development cycle.
Diane Paskiet, MS, Director of Scientific Affairs, Scientific Affairs and Technical Services, West Pharmaceutical Services
Fran DeGrazio, Vice President, Global Scientific Affairs and Technical Services, West Pharmaceutical Services
Training Seminar Information
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.