Cambridge Healthtech Institute’s Inaugural

Detection, Characterization and Control of Impurities in Biologics

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

August 16-17, 2018


Cambridge Healthtech Institute’s Inaugural Detection, Characterization and Control of Impurities in Biologics conference will bring together leading scientists from biopharmaceutical industry, academia and government 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 and manufacturing. Through new presentations, informative panel discussions, 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 new and novel technologies for virus and pathogen detection, host cell proteins, lipases and enzymatic degradation, aggregations, leachable, chemistry and manufacturing controls (CMC) strategy for regulatory filings.


Preliminary Agenda


DETECTION, CHARACTERIZATION AND CONTROL OF VIRUSES AND PATHOGENS

TSE and Virus Control Framework for the Development and Manufacture of Biopharmaceuticals

Anne Stokes, PhD, GSK Fellow and Director, TSE and Virus Control, GMP Operations, Biopharmaceutical Development and Supply, GlaxoSmithKline

Next-Generation Sequencing: A New Approach to Adventitious Virus Detection

Cassandra Braxton, PhD, Scientist II, Quality Technology & Development, Biogen

Second Generation Reference Materials for Adventitious Virus Detection by Metagenomics

Edward Mee, DPhil, Senior Scientist, Live Viral Vaccines, Virology, National Institute for Biological Standards and Control

Predicting MVM Clearance by Nanofiltration and Anion Exchange Chromatography Using a Non-Infectious “Mock Virus Particle

David Cetlin, Founder & CEO, MockV Solutions LLC


REGULATORY PERSPECTIVE, REFERENCE STANDARDS AND OTHER CONSIDERATIONS

Control of Impurities for Novel Biologic and Biosimilars from Regulatory Perspective

Audrey Jia, PhD, Principal Consultant, Regulatory Affairs, DataRevive LLC, Ex-FDA Office of Biotechnology

New Reference Standards for Monitoring Proteinaceous Particles in Biotherapeutics

Srivalli Telikepalli, PhD, Research Chemist, Biomolecular Measurement Division, National Institute of Standards and Technology

Sources of Particles in Biologic Products: Considering Assessment of Packaging Materials

Diane Paskiet, MS, Director of Scientific Affairs, Scientific Affairs and Technical Services, West Pharmaceutical Services


DETECTION, CHARACTERIZATION AND CONTROL OF PRODUCT-RELATED IMPURITIES

Continuing Advances in Risk Mitigation in the Use of Fetal Bovine and Other Sera

Rosemary J. Versteegen, PhD, CEO, International Serum Industry Association

Appearance of a Novel Basic Charge Variant during Redevelopment of a Monoclonal Antibody Production Process: The Path to Identification and Control

Jeremy Pike, MS, Development Scientist, Early Stage Process Development, Alexion Pharmaceuticals

Control of Host Cell Proteins and Host Cell DNA

Jamie Valeich, Senior Research Associate II, Gilead Sciences




For more details on the conference, please contact:

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


For partnering and sponsorship information, please contact:

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

Companies L-Z
Carolyn Benton
Business Development Manager
Cambridge Healthtech Institute
Phone: 781-972-5412
Email: cbenton@healthtech.com


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Premier Sponsors:

Millipore Sigma
Unchained Labs