Ruth Frenkel

•Analytical program lead for 3 gene therapy programs, ensuring method readiness for separations and biophysical characterization methods for AAV capsid purity and residual impurities. • Established cross-functional collaborations to enhance process efficiency and accelerate product development. • Implemented mass photometry and a cost-effective TEM quantitation model for AAV empty capsids, driving a 400% increase in sample testing capacity.

• Analytical program lead on a cross-functional CMC team for a Ph III AAV gene therapy program, managing method development and qualification to strengthen the analytical control strategy for impurity assessments. • Authored BLA Module 3 sections S.2.3 and S.2.4, and contributed to impurity characterization section, ensuring FDA compliance, and meeting submission timelines. • Designed and managed the execution of experiments internally and at external CRO and CDMO partners to generate robust analytical data to support OOS and OOT investigations, Drug Product development objectives, and manufacturing timelines.

• Developed a QC-friendly platform approach for measuring AAV empty capsids in multiple serotypes, suitable for process characterization and release testing, enabling an end-to-end control strategy. • Led investigations and designed analytical studies to elucidate root cause of OOT assay results and implement effective mitigation strategies, leading to improvement in upstream processes.

• Managed a team of 4 scientists and associates, resulting in streamlined chromatography and physicochemical method development, qualification, and method transfer processes for biologics. • Analytical program lead on cross-functional product development teams for early-stage complex biologics, including Fc-fusion and conjugated hemophilia therapies. • Led cross-functional initiative to streamline platform method qualification, resulting in 300% shorter timelines, faster on-boarding of in-licensed and R-to-D programs, and expedited method transfers to QC.

• Developed release and characterization methods for early- and late-stage biologics programs including HPLC, UPLC, LC-MS/MS, and GC-MS based methods. • Qualified analytical methods used to monitor product quality attributes for in-process samples, drug substance, and drug product; supported analytical investigations for clinical and commercial stage programs, and authored SOPs and technical reports.

• Characterized early and late-stage clinical candidates using LC-MS/MS methods for protein posttranslational modifications, N-glycan identification, sequence confirmation, disulfide connectivity, and structure-activity relationship studies. • Developed novel LC-MS/MS and GC-MS metabolomics approaches for characterizing raw materials and cell culture processes contributing to enhanced upstream process understanding and control.

• Developed platform methods and optimized method qualification protocols for SEC, icIEF, CE-SDS, and N-glycans assays, leading to more consistent method qualifications and enhancing overall data quality and compliance.

•Product quality and compendial testing for mAbs •Enhanced company-wide data integrity by establishing uniform nomenclature for N-glycans and standardized appearance color and clarity terminology, ensuring regulatory compliance and improved product quality. Engaged with key stakeholders in quality and regulatory to develop a change management plan for legacy commercial products.