Cambridge Healthtech Institute’s Fifth Annual
Rapid Methods to Assess Quality & Stability of Biologics:
Improving Prediction and Screening
Part of CHI's Ninth Annual The Bioprocessing Summit
August 21-22, 2017 | Westin Copley Place | Boston, MA
Assurance of quality and stability of biologic formulations over the course of intended usage is critical in developing safe and efficacious biopharmaceutical products. Increasing regulatory expectations and aggressive development timelines calls for rapid methodologies to predict and assess the quality and stability of biologics. The fifth annual Rapid Methods to Assess Quality & Stability of Biologics conference will bring together experts in analytical and formulation development to discuss regulatory expectations, prediction and manipulation for protein stability and instabilities caused by particles, higher order structures and impurities. We are seeking case studies and strategies, especially unpublished and innovative work on methods employed in real time and accelerated stability studies, protein aggregates and effective use of DoE for assessment and data comparability from early to late stage development.
KEYNOTE PRESENTATION: Talk Title to be Announced
Yatin Gokarn, Ph.D., Head, Global Pharmaceutical Development Biologics, Sanofi Genzyme
Critical Considerations in the Characterization of Protein Higher Order Structure (HOS) and Its Relationship with Stability and Function
Haripada Maity, Ph.D., Research Advisor, Formulation Development, CMC Development, Eli Lilly and Company
Application of Spectral Similarity Analysis for Product Comparability Exercises
Thomas F. Lerch, Ph.D., Principal Scientist, BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc.
Using Endoglycosidase and High Resolution Mass Spectrometry to Estimate the Level of MAN-5 and Afucosylation in Monoclonal Antibodies
Ming-Ching Hsieh, Ph.D., Research Advisor, BioAnalytical Science, Eli Lilly and Company
How Well Can We Predict Protein-Protein Interactions and Aggregation Propensity Using Molecular Models during Candidate and Formulation Assessment?
Christopher J. Roberts, Ph.D., Professor, Chemical & Biomolecular Engineering, University of Delaware
Understanding & Verifying Flow Imaging Particle Counters
Dean Ripple, Ph.D., Leader, Bioprocess Measurements Group, National Institute of Standards and Technology
Rapid Minor Variants Identification in Therapeutic Antibodies by 2D-LC/Q Exactive System
Jin Li, Ph.D., Senior Research Associate, Analytical Development and Quality Control, Genentech, Inc.
High-Throughput Analytics from RoboColumn Purification to Product Quality Screening
Sonia Taktak, Ph.D., Development Scientist III, Analytical and Pharmaceutical Sciences, ImmunoGen, Inc.
Novel Approach towards the Evaluation of Critical Quality Attributes and Stability of Proteins
Belinda Pastrana, Ph.D., Faculty, Chemistry, University of Puerto Rico
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