Elise Levi

• Leads the Bioassay and Potency Groups' analytics for all programs and defines science-driven, phase appropriate, and risk-based analytical development strategies to support the development candidate during advancing clinical development stages
• Determines timelines and priorities for analytical activities such as method development, qualification, and validation
• Fosters collaborative relationships with, and manages, contract research and contract manufacturing organizations (CROs and CMOs), aligning with ICH guidance documents, and collaborating with quality control and quality assurance
• Works closely with process development to ensure that an analytical strategy is developed for testing based on CQA identification, process control strategies as well as process development and characterization needs
• Works closely with, and supports quality control on technical investigations OOS, OOTs and release assay trouble shooting
• Provides primary technical expertise for analytical sections for regulatory filings
• Authors CMC analytical sections of regulatory submissions

• Built and led an in-house analytical development bioassay function comprised of more than 10 employees
• Provided strong knowledge, mentorship and technical leadership of analytical development processes to train junior staff and continuation of in-house analytical capability build
• Oversees the development, qualification and validation of analytical test methods and technology transfer at outsourced Contract Research and Contract Manufacturing Organizations (CROs/CMOs), in accordance with ICH guidance documents, including management of associated deliverables and timelines
• Lead the establishment of in-house systems and procedures to ensure adequate rigorous laboratory practices & regulatory requirements for analytical activities at its in-house facility
• Oversaw the establishment of in-house infrastructure (Analytical equipment procurement/qualifications, preparation and maintenance of SOPs, determination and control of critical reagents etc)
• Represented the Analytical Development function on matrixed CMC and other development teams

• Developed Guide RNA rAAV Vector Genome Titer Method
• Worked on cross-functional team to automate titer method on the Hamilton Star

Group Leader

• Head of the PCR and Immunoassay Development and Testing group in Analytical Development for gene therapy
• Managed a team of 4 Associate Scientists and a Scientist (all full time)
• Responsible for managing sample testing, method development, and product characterization of residual impurities in SGT-001 rAAV9 product to support Process Development
• Contributed to authorship of regulatory filing
• Authored section on method change justifications for product titer and residual DNA methods
• Collaborated on cross-functional teams focused on manufacturing and process development strategies
• Reviewed and approved method protocols and development reports
• Implemented 10+ assays in-house to support Process Development in less than 1.5 years
• Guided and supported GMP investigations at CDMO

CRO/CDMO Method Transfer Lead

• Completed transfer of 10+ methods to CRO for release testing
  Provided technical support to troubleshoot and optimize AAV9 ligand leachate immunoassay
• Transferred Solid's vector genome titer method to CDMO for in-process testing
• Team lead of AD method transfer to and qualification in QC
• Trained analysts on ddPCR method at CRO

Product Characterization Support

• Spearheaded project to characterize and quantitate residual DNA impurity fragments
• Developed residual HSV-1 protein assay on MSD platform
• Tested drug product samples for residual protein impurities using different commercial kits

Method Development

• Developed residual HSV-1 DNA method to characterize packaged and unpackaged DNA on ddPCR platform
• Assay was crucial in characterizing the clearance of unpackaged DNA through purification process
• Improved accuracy of measuring residual HSV-1 DNA in drug product

• Established an Analytical Development team with Supervisor in support of developing a gene therapy vector
• Sourced and purchased small and large lab equipment; scheduled IQOQs
• Provided regulatory support by developing new methods for residual impurity characterization in response to Agency comments and authored a report

AAV Vector Genome Titer

• Established and optimized qPCR AAV GOI titer assay in-house to support strategic decisions in Process Development and Manufacturing
• Transferred optimized titer assay to CDMO
• Implemented reference control and control charts to trend assay performance
• Supported sample testing and trained additional analysts
• Lead the development of AAV vector genome titer on ddPCR platform

Residual DNA

• Established residual HSV-1 qPCR method in-house from CDMO
• Supported in-house process development sample testing

Managing skills

• Managed a Postdoc in the Analytical Development Bioassay group

Bioassay Support and Troubleshooting

• Coordinated projects between cross-functional teams, such as Research
• Chemistry, and Bioassay, to meet milestones
• Supported protein and gene therapy projects
• Sourced reagents for assay development and qualifications
• Participated in a temporary work assignment in Cell Culture Development to support product stability investigation
• Troubleshooted and optimized sampling procedure for chromogenic titer method to increase robustness and to provide meaningful data to Process Development groups

Host Cell Proteins (HCP)

• Managed the production of in-house HCP reagents for numerous platform processes of three different cell lines in collaboration with Cell Culture and Purification teams
• Introduced 2-Dimensional gels and western blot methods on late stage products to include in the Biologic License Application (BLA) filing for the FDA
• Performed qualification work on process intermediates and drug substance for the testing of residual HCPs in a Meso Scale Discovery (MSD)-based immunoassay
• Performed regulatory response experiments and response writing for HCP reagent justification
• Developed and implemented immunoaffinity chromatography and 2D-DIGE to assess coverage of HCP reagents

Blood Brain Barrier Model

• Developed department’s first static in-vitro blood brain barrier (BBB) model using human endothelial cells to assess transport of products across the barrier
• Optimized sample purification method and sample prep for mass spectrometry analysis to assess product quality attributes of a biologic by peptide mapping

Bioassay Development, Qualification, and Testing

• Wrote protocols and qualification reports for binding assays developed on the
• MSD, TR-FRET, and Alphascreen platforms
• Developed an FcRn binding assay on the Octet Platform to assess relative potency of drug substance batches
• Tested drug substance samples in a flow cytometry-based antibody- dependent cellular phagocytosis cell-based assay

Reagent Inventory Support

• Supported Reagent Inventory transition from Freezerworks to the Laboratory Information Management System
• Performed user acceptance testing and provided feedback to the IT project team for enhancements

• Antibody Screening and Production
• Hybridoma Generation and Characterization
• Performed cDNA sequencing of candidate antibodies to determine variable- region/CDR sequences; analyzed data with DNAMAN and SeqMan
• Generated hybridomas using proprietary B-cell culture technology and using large-scale electrofusion
• Utilized ELISA-based screening techniques to identify hybridomas of interest
• Established protocols for large-scale electrofusion using the Cytopulse electrofusion apparatus

• Purified PCR samples.
• Performed Cycle Sequencing on the purified DNA products
• Purified sequenced DNA products after cycle sequencing
• Increased the efficiency of the sequencing team by turning out a significant amount of 96 well plates per day

• Applied important techniques such as differentiating NT2 cells into neurons as well as stimulating macrophages with CD40L
• Transfected macrophages with TRAF6 siRNA and confirmed TRAF6 silencing of macrophages with western blots and RT-PCR
• Completed a thesis on macrophage signaling inducing the release of neurotoxins