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 19 | PRE-CONFERENCE REGISTRATION 4:00 - 6:00 PM
MONDAY, JANUARY 20 - TUESDAY, JANUARY 21
Day 1: 9:00 am - 6:00 pm | Day 2: 8:45 am - 12:30 pm
TS8A: Protein Aggregation and Formulation Optimization - Detailed Agenda
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 - Detailed Agenda
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
TUESDAY, JANUARY 21 - WEDNESDAY, JANUARY 22
Day 1: 2:00 - 5:30 pm | Day 2: 8:15 am - 6:05 pm
TS8B: Next-Generation Approaches to Antibody Screening and Discovery - Detailed Agenda
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 - Detailed Agenda
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
thursday, JANUARY 23 - friday, JANUARY 24
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 - Detailed Agenda
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 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 manufacturing process and facilitating formulation
development: product purity and impurity analysis, product strength and potency assay, process-related impurities such as identification and quantitation of host cell proteins. The characterization panel specifically emphasizes structure elucidation
by mass spectroscopy, post-translational modification, biophysical characterization of higher-order structure (HOS), and protein aggregates. New real-world case studies and common pitfalls will be presented during the presentation.
Kevin Zen, PhD, Executive Director, Analytical Characterization, Formulation Development and Biologics Manufacturing, AnaptysBio Inc.