Navigating the Changes in USP <621>Chromatography: Key Updates, Implications,and Best Practices Challenges and Opportunities in the Implementation ICH Q2(R2) and ICH Q141
Guest Speakers:
Amanda Guiraldelli,Ph.D.
Senior Scientist RIC Group, BelgiumTimothy
Title: Navigating the Changes in USP <621>Chromatography: Key Updates,Implications, and Best Practices
Abstract: This presentation will provide an independent expert perspective on the major changes introduced inUSP General Chapter <621> Chromatography, which was harmonized with Ph. Eur. and JP andbecame official in the USP-NF on December 1, 2022. We will explore key updates, their implications,and practical considerations, with a focus on allowances for adjusting chromatographic conditionsin gradient elution. Through case studies, we will discuss best practices for implementing thesechanges, addressing challenges, and ensuring compliance. Additionally, we will provide an overviewof the latest updates regarding the new section on system suitability requirements for sensitivity andtailing factor, including the upcoming amended proposal to be published in Pharmacopeial Forum51(2) (March 3, 2025), with a targeted official date in USP-NF of June 1, 2026.
Bio: Amanda Guiraldelli, Ph.D. Senior Scientist, Proteins and Oligonucleotides Analytics RIC Group, BelgiumNavigating the Changes in USP <621>Chromatography: Key Updates,Implications, and Best Practices BiographyAmanda is a Senior Scientist specialized in proteins and oligonucleotides analytics at the CROResearch Institute on Chromatography Group (RIC Group) in Belgium. As a Subject Matter Expert inbiopharmaceutical analysis, she provides technical guidance on the development and validation ofanalytical procedures for release testing, stability studies, and characterization of biologicalproducts, while supporting ICH Q14 and AQbD-driven strategies to enhance procedure performanceand collaborating with key biopharma partners.With over a decade of experience at the United States Pharmacopeia (USP), Amanda served asscientific affairs manager and scientific liaison contributing to the development of USP standards,including USP <1220> on analytical procedure lifecycle, and led cross-functional initiatives toimplement AQbD-driven procedure development strategies, DoE, predictive modeling, andgenotoxic trace impurities analysis, collaborating with USP’s labs, industry partners, and globalregulatory bodies. Previously, Amanda worked for 8 years as a Senior Scientist at the USP ReferenceStandard Laboratory and as visiting scientist at TU Berlin and Leiden University focusing on LC-HRMS-based protein characterization and method development.She is an expert in chromatography and mass spectrometry (MS) applied to small and large moleculecharacterization, a frequent conference speaker, and mentors students on AQbD-related projects atthe University of Campinas (UNICAMP), Brazil. Amanda holds a Ph.D. in Analytical Chemistry fromthe University of São Paulo with a focus on MS-based metabolomics and chemometrics, and a B.Sc.in Pharmacy and Biochemistry.
Guest Speaker:
Timothy W. Graul, Ph.D.
Director Pfizer, CT
Title: Challenges and Opportunities in the Implementation ICH Q2 (R2) and ICH Q14
Abstract: ICH has recently adopted (step 4) two important guidelines on analytical procedures used for theassessment of the quality of drug substances and drug products, i.e., the revised guideline Q2(R2)“Validation of Analytical Procedures” and the new guideline Q14 “Analytical ProcedureDevelopment”. Q14 describes the scientific principles of development and lifecycle management ofanalytical procedures, and documentation of development knowledge for regulatory submissions.The revised Q2(R2) expands the scope to include validation principles for more advanced analyticalprocedures, as well as analytical procedures for biotechnological/biological Products. The purposeof this presentation is to share new concepts in ICH Q2(R2) and an approach to the lifecyclemanagement of analytical procedures based on performance, consistent with ICH Q14. Theapproach based on performance utilizes science and risk management principles described in ICHQ8-Q12, by following enhanced development practices to ensure the quality of the measured result.
Bio: Timothy W. Graul is a Director in the CMC Advisory Office within Pfizer at the Groton, CT site. Hereceived his B.S. Degree in Chemistry at James Madison University and then Ph.D. in AnalyticalChemistry at The Florida State University. After completing studies, Tim joined Pfizer AnalyticalR&D and supported the development of drug product formulations and drug substance syntheticroutes. During his time at Pfizer, Tim has been recognized as a leader in Enhanced Development foranalytical procedures. He has collaborated on publications that have been at the forefront ofindustry in this area. Tim served as the PhRMA Deputy Topic lead on the ICH Q2/Q14 ExpertWorking Group and is now an Industry Expert on the Implementation Working Group for the revisedQ2 Guideline and new guideline, Q14. He has been a member of industry groups including Land O’Lakes Pharmaceutical Analysis Conference Planning Committee and AAPS Summer ScientificForum since 2010, IQ groups such as Analytical Leadership, AQbD, Dissolution, Control StrategyHarmonization Metrics, and Worldwide Specification Harmonization; and is the co-lead of the ISPEPQLI group on Analytical Methods.
