Cambridge Healthtech Institute's Fourth Annual

Detection and Characterization of Particulates and Impurities

( 微粒子与杂质的检验及特性评估 )

Rapid Tools for Risk Assessment, Prediction and Characterization of Impurities from Products, Excipients, Processes and Packaging

2018年1月9日 - 10日

 

Particles and impurities can arise from the products and/or during any stage of bioprocessing or from the delivery devices and primary packaging. These impurities have the potential to impact stability, safety, efficacy of the biomolecules and biologic products. Therefore, early understanding, detection and characterization of the impurities are critical to ensure safety and efficacy of the drug product for its intended duration of use. The Fourth Annual Detection and Characterization of Particulates and Impurities conference provides a platform to explore novel tools and strategies to detect, characterize and carry out risk assessment of particles and impurities such as sub visible particles, host cell proteins, extractables and leachables, impurities from excipients and raw materials, glass and other particles etc. We are looking for cutting edge tools, research findings and unpublished data to be featured at this forum.

We invite you to present a poster and attend to join with colleagues in this discussion of the key challenges and solutions for prediction, characterization, risk assessment of particles and impurities from products and processes.

Preliminary Agenda


REGULATORY REQUIREMENTS AND GUIDANCE FOR EARLY AND LATE STAGE SUBMISSIONS

Anticipating Aggregation Propensity of Proteins at Early Formulation Development Stage: How to Support a Data-Based Approach for Immunogenicity Risk Assessment

Joel Richard, Ph.D., Vice President, Peptides, CMC & Engineering, Ipsen


PARTICLES, AGGREGATES AND IMMUNOGENICITY

Assessment of Immunogenic Risk Posed by Biologic Aggregation

Michael Swanson, Ph.D., Senior Scientist, Merck

Detection and Characterization for Sub-Visible and Sub-Micron Particles

Miguel Saggu, Scientist, Late Stage Pharmaceutical Development, Genentech

Identification of Micro Steel Particles Using Energy Dispersive X-Ray Spectroscopy Coupled with Multivariate Statistics

Jonas Hoeg Thygesen, Ph.D., Area Specialist, R&D - Microanalysis Centre, Novo Nordisk Pharmatech


HOST CELL PROTEINS AND PROCESS IMPURITIES

Host Cell Proteins, What We Know, What We Don't and How to Control

Judy Shimoni, Ph.D., Principal Scientist and Group Leader, Protein Analytical Chemistry, Genentech, Inc. A member of the Roche Group

Quantitation of Affinity Ligand Leachate in Processing Samples - Why Commercial Kits Fail and What You Can Do About It?

Xiaohui Lu, Ph.D., Senior Scientist, BioPharma Development, Biogen


FORMULATION COMPONENTS, RAW MATERIALS AND EXCIPIENT RELATED IMPURITIES

USP Standards to Monitor and Characterize Impurities in Biologics

Maura C. Kibbey, Ph.D., Director, Science & Standards, Global Biologics, U.S. Pharmacopeia


EXTRACTABLE AND LEACHABLE AND ANALYTICAL TOOLS

New NMR Methods for Fast and Efficient Analysis of Trace Leachables and Impurities in Biologics

Ken Skidmore, Technical Development Scientist, Protein Analytical Chemistry, Genentech, Inc. A member of the Roche Group


* 活动内容有可能不事先告知作更动及调整。