Katherine Calhoun Email & Phone Number

Chapel Hill, Nc, Us

Boston, Massachusetts, Us

New York, New York, Us

- Lead bioprocess development and scale-up of plasmid DNA production for AAV gene therapy programs.- Direct team responsible for supplying plasmid DNA for in-vitro transfection and AAV production.- Optimize downstream purification processes including chromatography, TFF, ultrafiltration, cell lysis, depth filtration, and final fill.- Develop microbial fermentation process and provide scale-up models of cell productivity using bench-scale bioreactor systems.- Proficient in DNA capsid design, sequencing, and analytical assay development.

New York, New York, Us

- Led teams throughout technology transfer, process development, and clinical trial phases of multiple mRNA vaccine and biologic projects.- Achieved cGMP status within a compressed timeline, enabling ahead-of-schedule launch of a new clinical mRNA vaccine production facility. - Improved mRNA downstream process robustness to meet desired titers and yields.- Streamlined production operations for mRNA vaccines, resulting in increased manufacturing efficiency.- Developed, implemented, and validated new process control systems (DeltaV) for clinical scale bioreactors, reducing validation time by 20%.- Developed SOPs, batch records, and process validation documents to ensure safety, consistency and reproducibility of the manufacturing process.

Lawrence, Ks, Us

- Optimized protein characterization and purification assays resulting in increased product quality and throughput of samples.- Designed and conducted experiments for the isolation and purification of novel proteins, which resulted in successful isolation of two target proteins.

Leverkusen, North Rhine-Westphalia, De

- Leveraged DeltaV database automation to create programs to simplify processes and increase efficiency. - Utilized system controls development and implementation to streamline operations and reduce process downtime.

St. Louis, Missouri, Us

- Developed downstream protein purification processes for manufacturing scale-up.

Libourne, Fr

- Led validation effort of two manufacturing process steps through the completion of field studies and cGMP risk assessment, reducing validation time for pilot-scale cell-based technologies.

Libourne, Fr

Developed new process automation initiatives to support continuous manufacturing improvement

Kansas City, Ks, Us

- Utilized analytical methods to characterize the produced bioproducts. - Monitored upstream/downstream process parameters and characterized proteins. —Department of Biochemistry and Molecular Biology

Bachelor Of Science (B.S.), Chemical Engineering

High School Diploma, Overland Park, Ks