Cambridge Healthtech Institute’s Seventh Annual

Optimizing Biologics Formulation and Stability  
( 生物製劑處方的最佳化 )

New Tools, Technologies, Case Studies, and Research Updates on Development of Novel Biologics

2019年8月14-15日


The seventh annual Optimizing Biologics Formulation and Stability conference will cover the latest trends and challenges in formulations development of novel biologic formats, process optimization, manufacturing, and device and packaging considerations for existing and emerging protein therapeutics. We are seeking case studies, especially unpublished and innovative work on co-formulation, formulation of novel biologics, development and delivery of high-concentration protein formulations, effective scale-up strategies, excipient induced instability, process challenges, fill-finish challenges, and predictive tools for rapid formulation and stability screening.

Preliminary Agenda

FORMULATION AND DELIVERY OF NOVEL THERAPEUTICS

KEYNOTE PRESENTATION: Combinatorial Development of Biomaterials for Islet Cell Therapy

Daniel G. Anderson, PhD, Associate Professor, Chemical Engineering and Institute for Medical Engineering and Science, Harvard-MIT Division of Health Sciences & Technology, Massachusetts Institute of Technology

Turning the Wheel: Implementation of Platform Technologies to Develop AAV-Based Gene Therapies

Pratik Jaluria, PhD, Executive Director, Process Development & Manufacturing, Adverum Biotechnologies, Inc.

EXCIPIENTS AND STABILITY

New Excipients to Prevent Particle Formation in Antibody Formulations

Philip Wuthrich, Senior Scientist, Research & Development, ReForm Biologics

Early Stage High-Throughput Formulation Analysis to More Extended Stability Studies

Brittney J. Mills, PhD, Senior Scientist II, Drug Product Development, AbbVie, Inc

HIGH CONCENTRATION PROTEINS FORMULATIONS

Excipients Modulate Viscosity of High Concentration Proteins in a Concentration Dependent Manner: Experimental and Computational Approaches

Danika Rodrigues, Associate Scientist, BioTherapeutics Drug Product Development, Janssen Research & Development

Predicting High-Concentration mAb Behavior from Measured Parameters

Thomas Laue, PhD, Professor Emeritus, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire

Advanced Strategies for Formulating High Concentration Antibody Products

Vishal Toprani, PhD, Development Scientist-I, Pharmaceutical Development, Alexion Pharmaceuticals

 

LOW CONCENTRATION FORMULATIONS, CO-FORMULATION & COMBINATION PRODUCTS

CMC Perspective on Clinical Trial Preparation for Low Concentration Potent Bispecifics; a Case Study of Glenmark’s BEAT

Sachin Dubey, PhD, Deputy Director, Formulation, Analytical and drug product development, Glenmark

Challenges and Strategies for Co-Formulation Development of Biologics in Combination Products

Mitra Mosharraf, Ph.D. M.Sc., EMBA Candidate, Consultant

 

* 活動內容有可能不事先告知作更動及調整。