Cambridge Healthtech Institute’s Inaugural
CMC Strategies for Antibody-Drug Conjugates
Linking Process, Methods and Assays for the Manufacture of ADCs
Part of CHI's 6th Annual The Bioprocessing Summit
August 18-19, 2014 | Renaissance Waterfront Hotel | Boston, Massachusetts
Conjugates are, as experts put it, “conceptually very simple, but in practice,
extremely complicated.” The complexity of the ADC, which combines an antibody
and a drug via a linker, means that it requires triple the amount of control
and characterization to achieve the right formulation, stability and
consistency for effective scale up and manufacturing that meets the regulatory
requirements. As more and more ADCs come
down the pipeline, it becomes imperative for companies to consider the
manufacturability of the ADCs, and to incorporate process design and CMC
strategies early on in the development stage.
CHI’s CMC Strategies for Antibody-Drug Conjugates
conference offers a platform for scientists and engineers to come together to
outline the challenges, share creative strategies, methods and solutions for
the safe and efficient manufacture of these highly potent and complex
Enhance your learning objectives by
attending a Short Course on ADC
Developability: Critical Quality Attributes Inform Formulation and Process
Development. This short course is conducted by Dr. Janet Wolfe of Wolfe
Laboratories, and is aimed at providing a molecular understanding of ADC CQAs,
and developing an array of analytical and biophysical techniques that you can
use to characterize these attributes for formulation and process design.
Innovations, Challenges and Opportunities in Antibody-Drug Conjugates
Janet L. Wolfe, Ph.D., President, Wolfe Laboratories
Druggable Extracellular Targets
Prudent, Ph.D., President & CEO, Centrose
Site-Specific Conjugation Approaches
– Comparison to Current Techniques
Laurent, Ph.D., Vice President, CMC, Ambrx, Inc.
Generation of ADCs 2.0 Using Novel
Toxins and Site-Specific Coupling
Pahl, Ph.D., CSO, Heidelberg Pharma
Carbohydrate-Mediated Site-Specific Antibody-Drug
Zhou, Ph.D., Principal Scientist, Protein Engineering, Genzyme
Characterization of Conformational Stability of Antibody Drug
Machinani Rao, Ph.D., MBA, Executive
Director, Analytical Sciences/Quality Control, Progenics Pharmaceuticals
Reactions of Antibodies and Antibody-Drug Conjugates
Christian Schöneich, Ph.D., Takeru
Higuchi Distinguished Professor and Chair, Pharmaceutical Chemistry, University
The Heterogeneity of ADCs and Its
Impact on Analytical Method Development and Characterization
Lily Liu, BS, Principal Associate, Formulation and Analytical
Development, Agensys, Inc.
Challenges and Considerations for Clinical
Development and Manufacturing of ADCs
Max, Ph.D., Associate Research Fellow, Biotherapeutics Pharmaceutical Sciences,
CQA Based Approaches to Formulation Development of an ADC Program
Aditya Wakankar, Ph.D., Associate Director,
Formulation & Analytical Development, Stem CentRx LLC.
of ADCs in High Ionic Strength Solution
Yilma Adem, Ph.D., Formulation Scientist,
Pharmaceutical Development, Genentech, Inc.
Development and Comparative Stability of Liquid and Lyophilized
Formulations for a Developmental Maytansinoid ADC
to be Announced, Immunogen
Challenges of an Antibody-Drug
Conjugate Drug Product Tech Transfer
Kristin Chan, BSc, Engineer, Pharmaceutical Processing & Technology
Development, Genentech, Inc.
Process Development of Scalable
Antibody Drug Conjugate Manufacturing Processes
Schwartz, Ph.D., Senior Engineer, Process Development, Agensys, Inc.
CMC Considerations for ADC Clinical
Tardie, Senior Regulatory Manager, Global CMC, Pfizer, Inc.
Externalization of ADC
Manufacturing: Challenges and Triumphs
Turula, Ph.D., MBA, Director, Biotherapeutics Pharmaceutical Sciences, Pfizer,
Breakout Discussions are facilitated, small-group discussions which
encourage interactive participation leading to problem-solving and future
collaborations around focused topics. Topics range from novel technologies, new
concepts or exciting strategies that relate to CMC challenges for ADCs. Each
breakout discussion will be facilitated by a moderator. Attendees can choose to
sit on any table they prefer.