PepTalk 2017
PepTalk 2017

Pipeline Five Header

Cambridge Healthtech Institute’s Third Annual
Detection and Characterization of Particulates and Impurities
Rapid Tools and Strategies for Risk Assessment, Prediction and Characterization of Particles and Impurities
from Products, Excipients and Processes

January 10-11, 2017 | Hilton San Diego Bayfront | San Diego, CA


Particles and impurities can come from the products, any stage of bioprocessing, or the delivery devices and primary packaging, and they have potential to impact stability, safety, and 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 Third 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.

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

Preliminary Agenda


REGULATORY GUIDANCE, REFERENCE STANDARDS AND CONTROL

Detection of Impurities: Use of Reference Standards

Fouad Atouf, Ph.D., Director, Global Biologics, United States Pharmacopeia

 

CHARACTERIZATION AND CONTROL
OF SUBVISIBLE AND OTHER PARTICLES

 

Subvisible Particles: Rapid and High-Throughput Tools for Prediction, Detection and Characterization of Subvisible Particles and Other Aggregates

Andrea Hawe, Ph.D., CSO, Coriolis Pharma

Forced Degradation and Impurity Characterization and Their Effect on Stability of Formulation

Anthony Tomlinson, Senior Research Associate, Late Stage Pharmaceutical Development, Genentech


DETECTION AND CHARACTERIZATION
OF PROCESS-RELATED IMPURITIES

LCMS Detection of the Residual Peptides from Yeast Extract and Hypep in In-Process Samples of Biotherapeutical Drug Substance

Guifeng Jiang, Ph.D., Senior Manager, Analytical Science, Boehringer Ingelheim


STRATEGY FOR ANALYZING AND MANAGING
HOST CELL PROTEIN IMPURITIES

Specific Immune Response to a Host Cell Protein Impurity

Sally Fischer, Ph.D., Principal Scientist, BioAnalytical Sciences, Assay Development and Technology, Development Sciences, Genentech

Reassessment of the Host Cell Protein Control Strategy for a Commercial Protein Product

John Rolf, Ph.D., Director, Corporate Quality, Product Quality Leader, Amgen

What We learned from MS-based HCP Analysis

Qingchun Zhang, Ph.D., Senior Scientist, Amgen


LEACHABLE AND RELATED IMPURITIES

Generic Approaches of Extractable Assessment of Ancillary Devices for Parenteral Dosing

Ping Wang, Ph.D., Principal Scientist, Material Sciences, Janssen R&D

New Studies on Leachables in Protein Production Lines

Gerhard Winter, Ph.D., Professor, Chair, Pharmaceutical Technology and Biopharmaceutics, LMU Munchen

New Tools and Improved in vitro/in vivo Models to Study Biocompatibility and Product Contact Assessment

Douglas E. Kiehl, Ph.D., Principal Research Scientist, Team Leader, Spectroscopy, Raw Materials and Extractables & Leachables, Bioproduct Research & Development, Eli Lilly and Company




For questions about the meeting, please contact:

Nandini Kashyap
Conference Director
Cambridge Healthtech Institute
Phone: 781-972-5406
Email: nkashyap@healthtech.com

For partnering & sponsorship information, please contact:

Companies A-K
Jason Gerardi
Manager, Business Development
Cambridge Healthtech Institute
Phone: 781-972-5452
Fax: 781-972-5470
Email: jgerardi@healthtech.com

Companies L-Z
Carol Dinerstein
Director, Business Development
Cambridge Healthtech Institute
Phone: 781-972-5471
Fax: 781-972-5470
Email: dinerstein@healthtech.com