Cassie Wolffis

Cell Culture & Bioprocessing• Upstream development in adherent and suspension systems, seed train expansion in T-flasks, cell stacks, shake flasks, Ambr250, and bioreactors (3–50L, scale-X Carbo and Hydro).• Viral vector (AAV, LVV, RVV), recombinant protein, and monoclonal antibody production with transfection and optimization. Experience across mammalian, bacterial, and yeast systems (HEK293, CHO, HeLa, A549, hybridomas, primary neurons).• Bioreactor monitoring and control using Flex2, Cedex HiRes, ViCell, Sartorius B-DCU, and BioPAT for batch, fed-batch, and perfusion.• Bench-scale process development, scale-down modeling, and optimization of media, feeds, and transfection reagents.Downstream Processing & Purification• Protein and viral vector purification on ÄKTA systems using affinity, ion exchange, size exclusion, and membrane chromatography.• TFF, UF/DF, SPTFF, depth/sterile filtration, clarification, centrifugation, and viral filtration.• Filtration and purification technology evaluation (Vmax, Pmax, Tmax) and development of scalable workflows.Analytical & Characterization• ELISA, Octet, SDS-PAGE, Western blot, PCR, IP1 HTRF, and high-throughput plate assays.• Media analysis (Rebel), spectroscopy (CD, fluorescence, UV/Vis), and advanced microscopy.• Process performance analysis including yield, recovery, impurity clearance, and fouling.Tech Transfer & GMP Documentation• Author SOPs, batch records, risk assessments, and process designs to support GMP readiness.• Transfer processes from development to GMP and support comparability studies and new technology implementation.• Deliver detailed process documentation for client and internal knowledge transfer.Project Leadership & Software• Lead scientific projects and manage onboarding, training, and mentorship.• Cross-functional collaboration and customer-facing technical leadership.• DoE and statistical analysis (JMP), GMP/cGMP systems, Veeva, BMRAM, Unicorn, Microsoft 365, Google Workspace, Teams, SharePoint, Salesforce.PUBLICATIONS (Under Miller CL)1. Miller CL*, Zhang C*, Zhang T*, Zou J*, et al., PMID: 27386547. 2. Miller CL*, Reddish FN*, Deng X*, et al., PMID: 336655523. Zhang C, Miller CL, et al., PMID: 27746744.4. Zhang C, Miller CL, et al., PMID: 25576451.5. Reddish FN, Miller CL, et al., PMID: 28570539.6. Reddish FN, Miller CL, et al., PMID: 28489021.7. Deng X, Xin Y, Miller CL, et al., PMID: 33709045.8. Deng X, Yu W, Li M, Miller CL, et al., 9. Ghane MA,… Miller CL, et al., PMID: 36998269*Authors contributed to work equally as co-first authors.