Middletown, New York, United States
rAAV vector production and purification. Lab-scale process development and optimization for adherent and suspension cell platforms. Vector analysis and characterization. Manager Viral Production & Innovation (VPI) Team for AAV Production/Process Development & Continuous Improvement
Viral Delivery Technologies- Regeneron Genetic Medicines High Throughput AAV Production/Continuous Improvement Team Process Development Analytics Development New Technologies
Regeneron Genetic Medicines High Throughput AAV Production/Continuous Improvement Process Development Analytics Development New Technologies
Viral Vector Technologies
• SME/Analyst for Total & Free Polysaccharide Quantitation of Men Quad-TT Conjugate Vaccine by High Performance Anion Exchange Chromatography with Pulsed Amperometric Detection (HPAEC-PAD) ◦ Operation of Dionex HPLC System, includes system setup, method writing, scheduling, and troubleshooting • Supported transfer of Men Quad-TT vaccine testing from Analytical Process & Technology to QC • Support routine release and stability testing for Men Quad-TT Conjugate Vaccine • Analytical tests; Dionex HPAEC-PAD, Multi-Angle Light Scattering (MALS), Sialic Acid, Phosphorus, BCA, Free Protein, Reducing Sugar Activity
Analytical Process & Technology (AP&T), Analytical Immunology • SME for quantification of Influenza Hemagglutinin (HA) protein by RP-HPLC ◦ Responsible for review and approval of HA testing for in-process flu production samples and Flu Support Lab samples ◦ Responsible for testing of seed samples from Operational Seed Team ◦ Review and approval of seed sample testing after training analyst to execute testing ◦ Execution of strain qualifications for new seasonal and pandemic flu strains ◦ System owner of Waters HPLCs used for HA testing, includes system setup, method writing, scheduling, and troubleshooting • Preparation of bromelain-cleaved purified HA (pHA) from flu virus strains using size exclusion chromatography (SEC) • SME for AKTA FPLC Chromatography systems, includes system setup, method writing, scheduling, and troubleshooting • Creation and Evaluation of method to allow for testing of Harvest Fluids by RP-HPLC utilizing modified Seed sample preparation technique • Co-Developed an improved RP-HPLC instrument method and sample preparation for HA analysis for the Operational Seed Team • Co-Lead in the organization and coordination of critical quick-turn-around testing to support season flu production ◦ Developed scheduling system, and sample preparation/HPLC management routine to ensure on-time delivery of results
• Chromatography Development Lead for Pneumo and Men Quad-TT Conjugate vaccines, Meninge B and C. difficile vaccines, and ADAPT monoclonal antibody biosimilar project • Development, Optimization, Scale-up and Transfer of Chromatography Processes • Biomolecule Separation and Purification; small and large-scale ◦ Extensive experience with HIC, IEX, and Protein A Affinity Chromatography; and Tangential Flow Filtration Techniques ◦ Proficient in use of AKTA chromatography systems and Unicorn software ◦ SME and system owner of AKTA systems, includes method writing, scheduling, and troubleshooting ◦ Design and Execution of DOEs for Chromatography Optimization • Production and purification of Phase I and II vaccine related polysaccharides, proteins, and conjugates in cGMP and non-cGMP environments • Prepared numerous reports and documents to support Phase I and II vaccine development • Designed and completed screening studies and optimization of chromatography media for use in purification of vaccine conjugates and proteins ◦ Recommendations implemented in the production of Men Quad-TT monovalent conjugates • Evaluation of prototype pre-packed chromatography columns for use in cGMP campaigns, ongoing collaboration with Merck EMD • Lead contact in collaborative development of novel, disposable membrane chromatography units with Sartorius and Millipore ◦ Authored report and prepared slides presented at annual Millipore conference • Analytical Tests and Techniques to characterize proteins, polysaccharides, and conjugates; SDS-PAGE, Silver Stain, Western Blot, BCA, Anthrone
• Production and purification of recombinant gene transfer vectors, including adenovirus, adeno-associated virus, and plasmid vectors for use in non-human and human trials; small and large-scale • Cell Culture and Viral Purification Lead and Trainer ◦ Isolation, Purification and Restriction Enzyme Digest of Plasmid DNA ◦ Cell Culture and Transfection of HEK293, CHO, PER.C6, and A549 cell lines ◦ Viral Purification via Gradient Ultracentrifugation • Development of fermentation and purification process for plasmid DNA production in E. coli; Stbl2 and DH5α ◦ Development and Optimization of Defined Media for plasmid DNA production ◦ Operation of Biostat C Fermentor ◦ Operation of AKTA Explorer and Pilot Chromatography Systems ◦ Reversed Phase and Ion Exchange Chromatography ◦ Tangential Flow Filtration; Hollow Fiber and Flat Sheet ◦ ELISA, UV-VIS Spectroscopy, SDS-PAGE
• Analysis of anti-HIV-1 antisense RNA drug product for phase I clinical trials • RT-PCR, PCR amplification of expressed RNA drug product from patient samples • Characterization of amplicon via Restriction Enzyme Digest and Gel Electrophoresis • Maintenance of HeLa and CHO cell lines