Join us for to discuss the validation of NGS-based adventitious agent testing (AAT) assays. Learn about the advantages of NGS for adventitious agent detection, key validation challenges, and recent regulatory updates — including ICH Q5A (R2) and European Pharmacopeia Chapter 2.6.41 — that are shaping the future of biosafety testing.

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Program

12:00 p.m. – 12:05 p.m.  Welcome and Introductions 
12:05 p.m. – 12:40 p.m.  Presentation 
12:40 p.m. – 12:55 p.m.  Q&A and Discussion
12:55 p.m. – 1:00 p.m.  Closing Remarks

Speaker Bio

Maggie Luce, NGS Scientist at MilliporeSigma

Maggie is a versatile scientist specializing in developing, optimizing, and validating next-generation sequencing (NGS) workflows across a range of applications. After earning her Bachelor of Science in Chemistry with a minor in biology from SUNY Geneseo, Maggie began her professional career at GeneDx, a leading clinical genetics testing laboratory. She also served as an Immunochemistry Scientist at PPD, where she focused on developing and validating pharmacokinetic and immunogenicity assays. Currently, she works at MilliporeSigma, where she develops and validates NGS assay workflows for identity testing, adventitious agent testing, and genetic stability testing of biopharmaceutical products.

Pricing Information

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• Non-Members*: $15

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