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Viral Safety for Biologicals

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Strategies, Technologies and Regulatory Perspectives for Detection, Prevention and Remediation in Upstream, Downstream and Manufacturing Operations

Alternate Language Options:

  • Japanese
  • Korean
  • Taiwanese
  • Chinese
  • English

February 27 - 28, 2012 · Hilton San Diego Bayfront Hotel · San Diego, CA

Event Overview

Event Overview

Recent adventitious agent incidents have resulted in increased regulatory scrutiny and the need for new technologies and risk mitigation strategies to detect, prevent and remediate viral contaminations in raw materials, cell culture processes and facilities throughout the entire supply chain.

Attend this conference to learn about:

  • Risk-based measures and strategies for mAbs, proteins and vaccine products
  • Novel strategies and technologies to establish effective viral barriers: How to detect adventitious agents we don't know about?
  • Nanofiltration and pre-filtration: new technologies, validation and regulatory guidance
  • Virus spike and ultrapure virus preparations: What is the process and regulatory impact?
  • Contamination case studies and facility protection strategies: lessons learned, corrective actions
  • Cell banks, cell lines, cell substrates and media: Is there value in raw material testing?

Featured Presentations

MMV Contamination: Detection, Root Cause Determination, and Corrective Actions
Mark D. Moody, Ph.D.
Vice President of Analytical Services
Merrimack Pharmaceuticals

Intelligent Process Design for Reducing Parvovirus Filter Costs
Jerome Bill Jr.
Engineer II, Purification Development
Genentech, Inc.

Applying a Risk-based Product Protection Strategy to a New Mammalian Cell Culture Bioprocessing Facility
Marie Murphy, Ph.D.
Microbiologist, Biotechnology Operations
Eli Lilly, Ireland

Testing Raw Materials for Adventitious Agents Prior to Use in Manufacturing
Sridhar Pennathur, Ph.D.
Senior Director, Biosafety Testing, Department of Quality Control
MedImmune, Inc.