Regulatory Speakers Provide Expectations for Protein Characterization

We are just two weeks away from IBC's Well Characterized Biologicals and co-located Product and Process Variants & Impurities conferences, taking place October 21-23, 2013 in Washington DC. Attending this event allows you to network with analytical scientists, process developers and executives from over 100 academic and industry organizations across North America, Europe and Asia all under one roof in this comprehensive three day forum. Gain exclusive insight on how to meet regulatory expectations for a wide range of molecules by hearing practical strategies and new techniques from experts at FDA, Health Canada, US Pharmacopeia and National Institute of Standards and Technology.

Strengthen your procedures to support the identity, strength, quality, purity and potency of your drug product and drug substances from FDA Team Leader Alfred Del Grosso's Top 10 List of Analytical Inadequacies for IND or BLA Submissions. Gain a thorough understanding of FDA expectations for analytical procedures and validations in this must-attend presentation for those currently working in analytical development/science.

Effectively remove product and process impurities and monitor your product quality by hearing FDA Principal Investigator Mikhail V. Ovanesov present his strategies to control the levels of implicated impurities by changing the manufacturing process. Details on how to properly monitor product quality using relevant lot release assays will also be discussed.

Want to learn more? Download our agenda.

As a reader of this blog, you’ll receive 15% off the standard rate when using code XB13193BLOG to register. If you have questions about the event, contact Kate Devery (Kdevery@iirusa.com), or visit our webpage.

We look forward to seeing you October 21-23 in Washington, D.C!

Cheers,
The WCB Team

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P.S. When you register for Well Characterized Biologicals, you’ll also have access to all sessions for our co-located event, Produce and Process Variants & Impurities conference.

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