Cambridge Healthtech Institute’s Seventh Annual

Rapid Methods to Assess Quality & Stability of Biologics
( 生物製劑的品質與穩定性 )

Improving and Accelerating Prediction and Screening 

2019年8月12-13日


The seventh annual Rapid Methods to Assess Quality & Stability of Biologics conference will bring together experts in analytical and formulation development to discuss regulatory expectations, prediction, measurement and manipulation for protein stability and instabilities in early and late-stage development. We are seeking case studies, unpublished work on new methods and tools employed in real time, and accelerated stability studies for proteins, cell and gene therapy products, high-throughput analytics, multi-attribute methods, biophysicals methods, HOS, use of DOE and QbB and immunogenicity.

Preliminary Agenda

NEW AND RAPID METHODS FOR FORMULATION SCREENING

Use of Affinity Capture - Self Interaction Nanoparticle Spectroscopy (AC-SINS) For Clone Ranking and Formulation Screen During Antibody Early Discovery

Tingwan Sun, PhD, Senior Scientist, Protein Analytics, Adimab LLC

Developing a Bio-Layer Interferometry Based Platform for Formulation Screening

Subhashchandra Naik, PhD, Senior Scientist, Reform Biologics

High Throughput Approaches to Enable Robust Early Stage Formulation Development

Laura Tanenbaum, PhD, Scientist, BioTherapeutics Drug Product Development, Janssen R&D

PHYSICAL AND CHEMICAL STABILITY

Protein Physical Stability: A Pre-Formulation Screening Based on Colloidal and Configurational Biophysical Properties

Cesar Calero-Rubio, PhD, Scientist, Biologics Drug Product Development, Sanofi

Predicting Physiochemical Stability of New ADCs Modalities from Discovery to Development

Kara Huang, PhD, Senior Scientist, Drug Product Development, AbbVie

Use of 2D NMR based HOS Fingerprinting to Probe Molecular Basis of Viscosity of Monoclonal Antibodies

Subhabrata Majumder, PhD, Postdoctoral Fellow, Pfizer, Inc.

Stability Study Design for Biologics

Dale R. Schmidt, MS, Senior Scientific Liaison, US Pharmacopeia

PARTICLES, PROTEIN AGGREGATES AND IMMUNOGENICITY

Qualification and Validation Methods for New Particle Counting Instruments

Dean Ripple, PhD, Leader, Bioprocess Measurements Group, NIST

Understanding and Mitigating Risk Due to Naturally Occurring Aggregates in Protein Based Formulations

Michael Swanson, Senior Scientist, Merck

Backgrounded Membrane Imaging (BMI) for High-Throughput Subvisible Particle Characterization During Biopharmaceutical Drug Product Development

Constanze Helbig, PhD, Postdoctoral Scientist, Coriolis Pharma Research GmbH


* 活動內容有可能不事先告知作更動及調整。