Biological Assay Development & Validation
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Event Wrap Up
In May, over 150 technical and regulatory professionals who are tasked with developing bioassays to support biopharmaceutical product development participated in IBC's 20th Biological Assay Development & Production Conference.
This year's conference was a unique blend of mini-tutorial talks, hands-on workshops and case studies that provided attendees the perfect mixture to help them return to the office/lab and be able to perform their job more efficiently.
Conference Highlights, Included:
- Keynote Presentation: Bioassays for Pharmaceutical Testing: Benefits and Limitations
Included a not-to-be-missed film giving a cell's eye view of a potency assay
Thomas Waerner, Ph.D., Head of Cell & Molecular Biology, Quality & Compliance, Boehringer Ingelheim RCV GmbH & Co KG, Germany - A Case Study on why selecting and maintaining critical rare reagents is difficult, and provided insights into what you needed to know before you get into trouble.
- Attendees found out how to move faster during development by using quality by design with a case study and update of EU approaches.
- How to avoid the common trap of poor modeling with practical suggestions from Amgen and Precision Bioassay, Inc.
- Mini-tutorial on statistical approaches to comparing bioassay that helped attendees to better understand critical requirements before they submit their proposal to the regulators.
- Learning how to keep up with evolving new trends from the chair of the USP bioassay committee. Update will cover chapters released in May 2010
Plus, this year the pre-conference workshop that included tough topics other conferences can't or won't address, including:
- Outlier analyses for bioassays
- Determining limit of quantitation
- Assay monitoring using Statistical Process Control (SPC)
- Bland-Altman approaches to demonstrate assay comparability
Attendee Testimonials
"The best thing is the variety and the opportunity of contact with the different "sides" of this area (regulators, manufacturers) CRO" - Alicia Jiminez, Researcher, CBER/FDA, LRSP/DBPAP
"Each time I attend this conference, I broaden my understanding of the challenges and solutions in this industry." - L. McNeill
"The best and most directly applicable information for our industry presented by industry leaders and newcomers alike. A most valuable resource." - R. Lowe
"An interesting and entertaining interface between biologists and statisticians. I would have loved to have all this information six months ago, and I greatly appreciate having it now." - M. Woodrow
"The information presented was illuminating, entertaining and informative so that even a statistician with almost no biological background could understand it." - R. Eyben
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