January 18-22, 2016 | Town and Country Resort Hotel | SAN DIEGO, CA 
January 18-22, 2016 | Town and Country Resort Hotel | SAN DIEGO, CA 

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Cambridge Healthtech Institute’s 4th Annual
Extractables and Leachables
Protecting Quality of Biologics by Ensuring Safety and Compatibility
January 21-22, 2016


In biopharmaceutical development and manufacturing, containers, drug combination products, and even disposable equipment may leach chemicals into the product that can pose significant risks to product quality and potentially compromise the stability, safety and efficacy of the biotherapeutics. The 4th Annual Extractables and Leachables (E&L) conference brings together industry experts and thought leaders to share their insights on latest updates and guidelines, how to design analytical testing strategies for E&L, case studies on identification and risk assessment E&L in single-use system, container closure system and delivery devices, and impact of leachables on biologics safety.

We invite you to present a poster and join colleagues from around the world in this discussion of the key challenges and solutions for E&L testing in biologics. .

Preliminary Agenda 


REGULATORY EXPECTATIONS AND UPDATES FROM WORKING GROUPS

The PQRI Parenteral and Ophthalmic (PODP) Leachable and Extractable Working Group: Outcomes and Practical Applications

Diane Paskiet, MS, Director of Scientific Affairs, West Pharmaceutical


FEATURED PRESENTATIONS

BPOG’s Extractable & Leachable Best Practice Protocol for Single-Use Components

Ken Wong, Deputy Director, MTech/AP&T - Extractables & Leachables, Sanofi Pasteur

BPOG’s Best Practice Guide for SUS Leachables Testing: Leachables Study Design for Single-Use Components

Kathryn A. McGohan, MS, Associate Scientist II, Manufacturing Sciences and Technology, Materials Science, Bristol-Myers Squibb


MATERIAL CHARACTERIZATION AND ANALYTICAL STRATEGY

Experimental Design Considerations for Extractables Simulation Studies

Dennis Jenke, Ph.D., Baxter Distinguished Scientist, Technology Resources, Baxter Healthcare Corp.

Extractables and Leachables Strategy for Parenteral Drug Products

Meera Agarkhed, Manager, Formulation Development, Eli Lilly and Company

Reaction Chemistry of Leachables in Pharmaceutical Drug Products

Carsten Worsøe, Principal Scientist, Novo Nordisk A/S

A Vision of Understanding Extractables and Leachables: Impact on Drug and Device Combination and their Manufacturing Processes

Yasser Nashed-Samuel, Ph.D., Principal Scientist, Process and Product Development, Amgen, Inc.


E&L TESTING FOR SINGLE-USE MANUFACTURING SYSTEMS

CMO Tech Transfer Material Control Strategies: A Case Study

Michael DiFiore, Scientist I, Materials Science, Bristol-Myers Squibb


PROCESS AND PACKAGING FACTORS AFFECTING AGGREGATION, SAFETY AND EFFICACY OF BIOLOGICS

Predicting the Risk of Extractables and Leachables (E&L) Interacting with Therapeutic Proteins

Kim Li, Ph.D., DABT, MPH, Senior Manager, Environment, Health, Safety and Sustainability, Amgen, Inc.

Extractables & Leachables in Liquid Formulations of Proteins: Impact on Stability, Aggregation, Potency and Immunogenicity of Drug Product

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

Talk Title to be Announced

Marisa K. Joubert, Ph.D., Senior Scientist, Process & Product Development, Amgen, Inc.

Investigation of Reversible Self-Association during Early-Stage Development of a Low-Concentration Antibody-Drug Conjugate

Elizabeth Bartlett, Scientist II, Analytical & Pharmaceutical Sciences, ImmunoGen, Inc.

Characterizing Changes in Protein Quality Attributes to Assess Leachable Risks from Single-Use Bioprocess Containers

Nina Xiao, Ph.D., Senior Research Associate, Late Stage Pharmaceutical Development, Genentech, Inc.




For questions about the meeting, please contact:

Kip Harry
Conference Director
Cambridge Healthtech Institute
Phone: 781-972-5454
Email: kharry@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