Regulatory Agencies Gather to Overcome Product Variance & Impurities

IBC's Product and Process Variants & Impurities addresses the approaches, methods, and technologies used to identify and effectively control variants and impurities. Learn about best practices and expectations directly from multiple regulatory agencies including FDA, US Pharmacopeia, NIST, and Health Canada. Get the answers and direction you need to comply with the current regulatory guidelines. Discuss your current challenges in our panel discussions, where you can talk directly with many of the conference speakers

FDA Advice on Removing Impurities and Monitoring Product Quality 

Reduce the risk of process- and product-related impurities in therapeutic products. Hear Mikhail Ovanesov, Ph.D., Visiting Scientist and Principal Investigator of the Laboratory of Hemostatis/Division of Hematology from CBER FDA's discuss how to control the levels of implicated impurities through changes in the manufacturing process. Dr. Ovanesov also discusses how to monitor product quality using relevant lot release assays.

Best Practices of US Pharmacopeia

Hear Fouad Atouf, Ph.D., Director of Biologics and Biotechnology of US Pharmacopeia discuss recommended practices for identifying and controlling product and process variants and impurities during the lifecycle of a biologic product. Obtain best practices for development, validation and use of residual HCP testing methods in Maura Kibbey, Ph.D., Senior Scientific Liaison in Biologics & Biotechnology of US Pharmacopeia's presentation covering the new chapter for measurement of residual host cell protein and DNA impurities in Biotherapeutics.

Lessons Learned from National Institute of Standards and Technology

Hear results and lessons learned in the NIST round-robin comparison for sizing and counting sub-visible particles from from Dean Ripple, Ph.D., Leader of Bioprocess Measurements Group , NIST. Geta snapshot of the level of agreement between different laboratories and for different particle counting instruments. New data on how particle detection instruments respond to non-spherical products (such as aggregated protein particles) is covered by Michael Carrier, Bioprocess Measurements Group of NIST.

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 PPVI Team

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

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