Cambridge Healthtech Institute’s 3rd Annual

Detection, Characterization and Control of Impurities in Biologics

Hot Topics, Emerging Contaminants and Impurities, Case Studies and New Technologies

August 27-28, 2020

 

CHI's conference on Detection, Characterization and Control of Impurities in Biologics will bring together leading experts to discuss hot topics, emerging contaminants, and impurities and new characterization tools for impurities that may come from various sources and stages of product development. Through new presentations, high-level poster presentations and interactive breakout discussions, top scientists will share new insights into characterization and control of various impurities. Some of the hot topics for this year will be impurities in cell and gene therapy products, new and novel technologies for virus and pathogen detection, host cell proteins, lipases and enzymatic degradation, aggregations, leachables, and chemistry and manufacturing controls (CMC) strategy for regulatory filings.

Preliminary Agenda

REGULATIONS AND GUIDELINES

Control of Impurities for Different Biological Products

Audrey Jia, PhD, Principal Consultant, Regulatory and CMC, DataRevive USA LLC

Impurity Identification and Characterization – A Regulatory Approach

Speaker to be Announced

PRODUCT AND FORMULATION-RELATED IMPURITIES

Detect, Characterize and Control Impurities During Biologics Manufacture and in the Final Product

Kevin Zen, PhD, Executive Director, Analytical Characterization, Formulation Development and Biologics Manufacturing, AnaptysBio Inc.

Detecting Product-Related Impurities during Method Transfer

Bryant Yan, PhD, Senior Director, Analytical Development and Quality Control, Acceleron Pharma

Impact of Silicone Oil on Fatty Acid Solubility and Polysorbate-Related Particle Formation

Raphael Fish, Engineer I, Process Development, Genentech

Managing Impurities in Cell and Gene Therapy Products

Speaker to be Announced

PROCESS-RELATED IMPURITIES

Characterization of Host Cell Proteins

Speaker to be Announced

Polysorbate Degradation due to Process and Product Impurities

Speaker to be Announced




For more details on the conference, please contact:
Nandini Kashyap, MPharm
Conference Director
Cambridge Healthtech Institute

Phone: (+1) 781-972-5406
Email: nkashyap@healthtech.com

 

For partnering and sponsorship information, please contact:

Companies A-K
Sherry Johnson
Senior Manager, Business Development
Cambridge Healthtech Institute
Phone: (+1) 781-972-1359
Email: sjohnson@healthtech.com

Companies L-Z
Carolyn Cooke
Manager, Business Development
Cambridge Healthtech Institute
Phone: (+1) 781-972-5412
Email: ccooke@healthtech.com



Premier Sponsors:

Fujifilm-Diosynth-Logo

NanotemperTechnologies

Samsung_Biologics

UnchainedLabs
Vironova