Scott Frazee Email and Phone Number

Subject Matter Expertise on Autologous T-Cell Manufacturing, Statistical Design of Experiments (DOE), and Statistical Process Control (SPC)Process Characterization – Afamitresgene autoleucel (afami-cel)o Design BLA-enabling process characterization and comparability studieso Lead team and manage resources for study executiono Train new employees in laboratory methods and manufacturing processesAutologous T Cell Manufacturing Process Monitoringo Lead and formalize biweekly meetings on manufacturing data trending (SPC)o Establish data trending SOP, initiate quarterly manufacturing trend reports, and formalize process version numbering standardso Lead lot failure investigationsSubject Matter Expertise in CMCo Review clinical manufacturing batch records, SOPs, deviations, and investigationso Provide technical analysis to support impact assessments and investigationso Support Regulatory submissions and Quality Assuranceo Lead change controls for process changes

Autologous T Cell Platform-Designed and executed studies to optimize non-viral gene transfer methods-Coordinated tech transfer of non-viral gene transfer technologies Lentiviral Vector Platform-Developed and scaled-up in-house RUO lentiviral vector production platform-Developed and optimized TFF methods for viral concentration-Author SOPs and standardized lentiviral analytical methods-Trained new employees on manufacturing and analytical process

Support translational research by serving as a subject matter expert in the areas of cell therapies and large scale cell culture. Develop and execute cell culture and upstream manufacturing processes that support the production of clinical trial materials for Waisman Biomanufacturing and its clients.

Process Optimization and Improvement:• Designed, performed, and analyzed studies utilizing DOE (Minitab & JMP)• Screened multiple factors for main effects, curvature, and two-factor interaction during T cell activation, electroporation, and viral transduction (AAV)Pilot Scale Runs:• Performed key unit ops for end-to-end pilot scale runs in preparation of tech transfer to CMO.Technical Documentation:• Authored Equipment SOPs, Process SOPs, and Production Batch Records

Subject Matter Expertise on human Stem Cell Culture, Flow Cytometery, and BioAssays Stem Cell Culture:• Maintained, expanded, and characterized multiple human induced pluripotent stem cell (iPSC) lines without antibiotics for all in house experiments• Authored and updated SOPs for stem cell culture and passaging• SME for investigation of methods for seeding, expanding, and passaging hPSCs on microcarriers for suspension cultureStem Cell Cardiac Developmental Toxicity Screen:• Translated 6-week manual cell culture (6-well) method to semi-automated high throughput (96-well) method utilizing Eppendorf epMotion platformFlow Cytometry:• Responsible for maintenance and operation of flow cytometer (Guava easyCyte)• Authored and updated SOPs for instrument operation and sample preparationQuality Control - StemAdhere™ and Vitronectin XF™ lot release: • Verified protein functionally by maintenance of phenotype in stem cells expanded on recombinant protein substrates for multiple passages (flow cytometry)• Verified protein identity and purity (SDS-PAGE, Western, LAL-endotoxin)SBIR Grants:• Collaborated in writing successfully funded Department of Health and Human Services SBIR phase I grant, “A Novel Defined Xenobiotic Free Substrate that Mimics Natural Extracellular Matrix” (Contract #: 1R43GM113484-01)