Katy Barglow Email & Phone Number

Emeryville, California, Us

Emeryville, California, Us

Functions:-Clinical Manufacturing and Supply Chain-Process Development-Analytical Development-Clinical QC-CMC Project Management

Emeryville, California, Us

Emeryville, California, Us

Director of Process Development (upstream, downstream, and analytical) for gene therapy (AAV) products. Responsible for team engaged in key IND-enabling process development studies, including DOE-based optimization of upstream and downstream unit operations (cell expansion, transfection, harvest, clarification, column chromatography, TFF) and development, qualification, and transfer of IND-enabling assays (purity, potency, safety, identity)

Sant Cugat Del Vallès, Barcelona, Es

Analytical Group LeaderSubject Matter Expert in Analytical Methods Duties include:-Management of group of 6-8 associates performing analytical testing in support of small scale work-Directing assay development/improvement projects-Support QC validation/re-validation, assay improvements, and new assay implementations. -Lead and assist in investigations relating to Manufacturing or QC deviations and Out of Specifications (OOSs) and develop studies to determine their root causes. Identify and implement appropriate CAPAs. -Support process and product characterization, validation, and continuous verification, and cleaning validation studies. Support assay and process transfers.-Author technical documents including reports, protocols, product impact investigations, risk assessments, change controls, and deviation reports.

Deerfield, Illinois, Us

Research scientist II in the Process Analytical Development group, (Promoted from Research Scientist I Sept 2013. Interim Acting Manager of Analytical Group from March-July, 2014). -Assay development, qualification, and QC transfer for protein therapeutics -HPLC, UPLC, ELISA, Mass Spec, Glycan assays -degradation and stability studies -protein analytics and micro-heterogeneity assays-Analytical SME for multiple projects-OOS and OOT investigations-Worked in a GLP/GMP environment -Led a team of 3 research associates-Worked closely with quality, validation, regulatory, and QC groups-Authored sections of IND and BLA submissions (3.2.S. sections, including Elucididation of Structure and Other Characteristics, Impurities, Analytical Procedures, Specifications, and Control of Materials Sections). -Led and participated in FMEAs and risk assessments. Authored multiple technical documents (Memos, Technical Reports, Assay Qualification Reports, Comparability and Stability protocols and reports)

Developed bioanalytical assays for modified recombinant proteins-Generated and characterized protein conjugation products-Developed MALDI and LC-MALDI assays to determine the selectivity of PEG-modified proteins-Provided mass spec and analytical support for protein purification-Trained others in the use of MALDI for protein characterization

South San Francisco, Ca, Us

Provided bioanalytical and mass spectrometry support for Protein Science and Assay Development groups. Designed and implemented analytical assays for recombinant proteins. Developed novel degradomics capabilities.-Implemented new N-glycan assays which reduced turnaround time from one week to three hours while increasing sensitivity and reproducibility and reducing sample requirements. Allowed protein quality to be quickly assessed prior to in vivo studies, leading to an increase in screening efficiency.-Designed novel isotope and chemical labeling techniques for monitoring protease selectivity (degradomics). Improved characterization of therapeutic protease candidates in purified and complex systems, giving essential information for future design rounds.-Analyzed recombinant protein quality (sequence, N- and O-glycan identity, site occupancy and sialic acid content, proteolytic processing, and post-translational modification) and correlated this information with plasmid design, allowing optimization of therapeutic candidates.

Berkeley, Ca, Us

Postdoctoral Fellow of the American Cancer Society, in the laboratory of Michael A. Marletta. Working on elucidating mechanisms of specificity of S-nitrosation.-Developed a mass-spec based method allowing the first kinetic measurements of nitrosation on whole proteins, leading to rate data for nitrosation of specific cysteines on a protein involved in cellular nitrosation.-Performed proteomics experiments that provided strong evidence for cellular signaling via transnitrosation.-Coordinated a two-lab, bicoastal collaboration (Steve Tannenbaum lab, MIT) leading to peer-reviewed publications.

La Jolla, California, Us

Graduate student in the laboratory of Benjamin Cravatt, department of Chemical Physiology, working to expand proteome coverage of activity-based protein profiling technologies and their application to enzyme annotation.-Designed, synthesized, and utilized new classes of activity-based chemical probes for proteomics, and used these probes to discover novel biomarkers for obesity and diabetes.-Utilized chemical proteomics for substrate discovery in uncharacterized enzymes. Used molecular docking studies and mutagenesis for confirmation.-Produced protein crystals leading to the first structure of a mammalian nitrilase enzyme (1.4 Å resolution).

Doctor Of Philosophy (Phd), Biochemistry

Postdoctoral Fellow

B.S, Chemistry