IBC Announces The 11th Annual Well Characterized Biologicals Conference
IBC Life Sciences announced the dates for the eleventh annual Well Characterized Biologicals conference, set to take place November 12-14 in Reston, Virginia. The conference is designed for thought leaders and decision makers within the protein characterization industry. This year's program will assist companies of all sizes and at various levels of development to overcome the technical and regulatory hurdles of characterization through coverage of emerging analytical techniques and technologies to improve process and product understanding.
The program includes eleven sessions, six case studies, four regulatory presentations and a keynote address. There will also be a panel discussion titled "Extractables and Leachables - Perspectives from the Suppliers" which will allow attendees to assess end-user and suppliers' analyses of the effects of extractables and leachables on well characterized protein products.
Attendees will learn the root causes of product aggregation and techniques for accurate detection and assessment. They will have the opportunity to hear the latest FDA perspectives on potency assay formats, analytical methods limitations, qualifying impurity levels, and evaluating extractables and leachables.
Keynote and Featured Presentations include:
Keynote Address
Current and Future Challenges of Bringing Biopharmaceuticals to Market
Louise E. Duffy, Ph.D., GlaxoSmithKline
Featured Regulatory Presentations
Potency Issues - Cell-Based Functional Assays vs. Binding Assays
Emily Shacter, Ph.D., CDER, US FDA
Problems and Limitations with Current Analytical Methods - A
Regulator's Perspective
Malcolm Moos, M.D., Ph.D., CBER, US FDA
Assessing Impurities in Biotherapeutics
Kathleen Clouse, Ph.D., CDER, US FDA
Regulatory Considerations for Evaluating the Impact of Extractables and
Leachables - A Risk-Based Approach
Ingrid Markovic, Ph.D., CDER, US FDA
Complete conference information can be found at www.IBCLifeSciences.com/WCB.
About IBC Life Sciences
IBC Life Sciences is the worldwide leader in scientific, technological and business summits and courses for the life science industry. To develop its programs, IBC actively researches the advancements, technologies and trends impacting and driving the race for new drugs and therapies. No other organization can make claim to the breadth and quality that IBC Life Sciences delivers in each event giving the company recognition around the globe for quality, service and value. For more information, visit: www.IBCLifeSciences.com.
SOURCE: IBC Life Sciences