Cambridge Healthtech Institute Training Seminars offer real-life case studies, problems encountered and solutions applied, along with extensive coverage of the academic theory and background. Each Training Seminar offers a mix of formal lecture and interactive discussions and activities to maximize the learning experience. These Training Seminars are led by experienced instructors who will focus on content applicable to your current research and provide important guidance for those new to their fields.
SUNDAY, JANUARY 13
4:00 - 6:00 pm Pre-Conference Registration
MONDAY, JANUARY 14 - TUESDAY, JANUARY 15
DAY 1: MONDAY
9:00 am - 6:00 pm Seminar Sessions
12:30 - 2:00 pm Lunch Provided
3:15 - 4:30 pm BuzZ Sessions
6:00 - 7:15 pm Welcome Reception
DAY 2: TUESDAY
8:30 am - 12:30 pm Seminar Sessions
Exhibit Hall Refreshment Breaks also provided.
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.
Sheila G. Magil, PhD, Senior Consultant, BioProcess Technology Consultants, Inc.
Frank J. Riske, PhD, 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 naïve libraries and antibody characterization. The seminar will be fully interactive with students provided with ample opportunities to discuss technology with instructors.
Andrew M. Bradbury, PhD, MB BS, CSO, Specifica, Inc.
James D. Marks, MD, PhD, Chief of Staff, Chief of Performance Excellence, Zuckerberg San Francisco General Hospital and Trauma Center; Professor of Anesthesia, UCSF Department of Anesthesia and Perioperative Care
TS10A: Fundamentals of Proteins and Protein Solutions
A simple energy framework is presented that allows a fundamental, but very practical, understanding of protein structure, folding, stability, interactions and solution behavior. The seminar focuses on the practical understanding and application of the energy framework. Building on a review of basic biochemistry and central energy concepts, the framework is used to build up a deeper understanding of how protein folding and structure arise from the properties of its constituent atoms and amino acids. This same energy framework is used to understand protein interactions with small molecules, surfaces, other proteins, and other macromolecules. The importance of cooperativity to biological processes is discussed.
Thomas Laue, PhD, Professor Emeritus, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire
TUESDAY, JANUARY 15 - WEDNESDAY, JANUARY 16
DAY 1: TUESDAY
2:00 - 5:30 pm Seminar Sessions
DAY 2: WEDNESDAY
8:15 am - 6:05 pm Seminar Sessions
12:15 - 1:30 pm Lunch Provided
6:05 - 7:00 pm Networking Reception
Exhibit Hall Refreshment Breaks also provided.
TS2B: Next-Generation Approaches to Antibody Screening and Discovery
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
TS10B: Introduction to Biologics Formulation Development
In this training, you will learn strategies to plan and execute preformulation and formulation development studies for biologics. The seminar offers an overview of biophysical and biochemical properties of proteins and protein structure, 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, PhD, Director, Biopharmaceutical Development, KBI Biopharma, Inc.
TS11B: GMP and Validation Requirements for Biologics Processes – Phase I through to Commercial Manufacturing
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
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.