Kevin Yi

Responsibilities & Achievements：Responsibilities & Achievements Led the establishment of the company’s R&D platform and the development of high-performance molecular diagnostic enzymes for IVD applications. As project leader, built an enzyme product development platform covering specialized PCR amplification enzymes and enzymes for mRNA therapeutics, including plasmid sequence design, fermentation process development, chromatography process development, and analytical assay development. Developed IVD enzyme products (e.g., Taq DNA polymerase). 2023/02-To Present Multiplex PCR Mix Development Designed and screened multiple Taq DNA polymerase mutants via literature research and rational protein engineering, identifying two inhibitor-resistant variants for downstream amplification testing. Developed and validated qPCR mix products, including performance evaluation and functional assays: Enzyme QC: purity, concentration, nucleic acid contamination, host protein residues, enzyme activity. qPCR Mix QC: limit of detection (LOD), specificity, precision, linear range, antibody hot-start efficiency. Stability studies: 37 °C accelerated testing, freeze–thaw stability, inhibitor tolerance (e.g., heparin, EDTA, whole blood). RPA Product Development Developed processes and formulations for recombinase polymerase amplification (RPA) enzymes, including UvsX, UvsY, and DNA polymerases. mRNA Enzyme Raw Material Development Initiated projects targeting the growing demand for mRNA therapeutic enzymes. Established process development and activity assays for T7 RNA polymerase, inorganic pyrophosphatase, capping enzyme, and 2'-O-methyltransferase. Intellectual Property Filed multiple patents, including: Polymerase Chain Reaction Kit (CN222934371U) Anti-contamination storage device for mRNA enzyme raw materials (CN222794042U)

Responsible for the development and routine operation of the mRNA process platform, covering key steps including plasmid fermentation, plasmid purification, plasmid linearization, IVT (in vitro transcription), and capping, as well as intermediate and final product quality control (QC) testing. Established comprehensive QC schemes, including literature research, method development, raw material procurement and testing, reference standard establishment, preliminary method validation, critical step testing, and stability studies. Gained solid expertise in mRNA and plasmid quality control methodologies, and developed key assays such as HPLC-based capping analysis and capillary electrophoresis detection using FA5200 for plasmid/mRNA purification and quality assessment.

Responsibilities & Achievements：Led team in developing PCR enzymes (Taq DNA polymerase & reverse transcriptase) from plasmid construction through strain preparation, purification, and QC, achieving project milestones on time. Established full QC system for Taq polymerase (purity, nucleic acid residues, exo-/endonuclease activity) and validated performance assays for sensitivity, efficiency, specificity, and precision. Built and managed PCR laboratory operations, standardizing workflows from reagent preparation to amplification analysis. Directed QC function under ISO13485, including method validation, personnel training, system design, and continuous optimization of quality testing.

Responsibilities & Achievements：Led testing operations and daily safety management of the China AN Application Laboratory (2019 H2), evaluating the impact of operators, reagents, and instruments on processes to ensure SOP compliance and reliability of testing results. 2022/08-2023/01 2021/01-2022/07 2017/11-2021/01 Conducted activity analysis and catalytic performance evaluation of in-house enzyme products (xylanase, phytase, protease, amylase, β-glucanase, etc.) and competitor products, including substrate specificity, enzyme purity, thermostability, and long-term storage stability. Coordinated with DuPont laboratories in Denmark, India, and Brazil for regular technical exchanges; organized and executed EQA result evaluations and facilitated the transfer and validation of newly developed analytical methods.

Responsibilities & Achievements：Led the establishment of a comprehensive management system for molecular diagnostic reagent laboratories and oversaw daily operations. Built an R&D and production system based on bioreactors, covering seed culture preparation, fermentation induction, cell harvest and clarification, homogenization and cell disruption, clarification filtration, chromatographic purification (capture, intermediate, polishing), and buffer exchange via ultrafiltration/diafiltration. Defined quality standards for molecular diagnostic enzyme raw materials and developed corresponding analytical methods. Transferred products to the genetic analysis department, enabling replacement of imported enzymes and achieving domestic substitution for key reagents such as Taq DNA polymerase, Taq DNA ligase, T4 DNA polymerase, KlenTaq, and phi29 DNA polymerase. Developed product application systems, including hot-start modification of Taq DNA polymerase for use in PCR, qPCR, multiplex SNP detection, copy number analysis, and Sanger sequencing. Applied Quality by Design (QbD) and Design of Experiments (DoE) principles to optimize existing diagnostic enzyme production and reaction systems, successfully meeting both internal and external requirements of the company

Graduated from the State Key Laboratory of Cellular Stress Biology, Xiamen University. Contributed as a core member to multiple National Science Foundation projects, focusing on the biochemical characterization and structural biology of enzymes. Demonstrated expertise in HPLC chromatography, dynamic light scattering (DLS), and enzyme activity assays, with hands-on experience in both research and method development. Collaborated closely with interdisciplinary teams to advance understanding of enzyme mechanisms and structure–function relationships.