Joongwon Park

A biotechnology company focused on identifying neoantigens through genomic analysis and developing personalized cancer vaccines and therapeutics. [English] mRNA & LNP Analytical Development — Associated Research (2024.08 ~ Present) A. mRNA Drug Substance (DS) Analytical Method Development - Integrity Testing: Established mRNA integrity assays using Agilent TapeStation and Bioanalyzer platforms. - dsRNA Quantification & Qualification: Developed qualitative dot blot assays for dsRNA detection.; Established quantitative ELISA-based dsRNA assays. - Residual Protein Testing: Set up residual protein assays using the NanoOrange Protein Quantitation Kit. - Endotoxin Testing: Established LAL endotoxin testing (Thermo Fisher reagents) for DS materials. B. mRNA–LNP Drug Product (DP) Analytical Method Development - Concentration & Encapsulation Efficiency: Developed Ribogreen-based assays for mRNA quantification and encapsulation efficiency. - Endotoxin Testing for DP: Set up LAL endotoxin assays for DP-level testing. (Thermofiser kit) C. In Vitro & In Vivo Functional Assays - In Vitro Evaluation: Assessed DP functionality by transfecting DC2.4 and HEK293T cells to confirm protein expression (Luciferase assay, OVA presentation via flow cytometry). - In Vivo Immunogenicity: Conducted mouse studies to evaluate immune responses using ELISpot assays. D. Production System Establishment - Built an in-house DS synthesis platform suitable for small-scale research environments. - Established LNP formulation workflows using NanoAssemblr Ignite. - Authored production development reports and SOPs, enabling a reproducible and stable manufacturing system. E. Documentation & Reporting - Prepared analytical method development reports, DS/DP process development documents, and SOPs for internal implementation.

A company developing mRNA-based NK engager treatment - mRNA platform development [English] Process & Analytical Development Team — mRNA Synthesis and Characterization A. mRNA Drug Substance (DS) Analytical Testing - Integrity Analysis: Performed mRNA integrity evaluations using the Agilent Fragment Analyzer. - Residual Protein Testing: Established a DS residual protein assay using the NanoOrange Protein Quantitation Kit. - Endotoxin Testing: Set up and executed LAL endotoxin assays (Lonza). - Residual DNA Testing: Performed residual DNA quantification using RT-qPCR. B. mRNA Drug Substance (DS) Synthesis & Purification - Conducted DS synthesis using various raw materials and optimized reaction conditions. - Performed purification studies using FPLC (ÄKTA Avant), including manual methods and Oligo-dT affinity chromatography. C. mRNA DS Stability Studies - Conducted long-term stability studies of mRNA DS. - Evaluated degradation via integrity assays. - Performed in-vitro protein expression assays to assess functional stability. D. Documentation & Reporting - Authored research reports, analytical method development documents, and protocols related to DS synthesis and purification. [Korean (한글)] * 기초 및 공정 개발팀: mRNA 합성 및 분석 담당 [DS (mRNA) 분석법 수행] • Integrity 확인 시험 - 분석기기Fragment analyzer를 이용한 분석법 수행 • 잔류 단백질 확인 시험 - NanoOrange kit를 이용한 DS 내 잔류 단백질 확인 시험법 셋업 • 엔도톡신 확인 시험 - LAL assay (Lonza 제공)를 통한 DS 엔도톡신 확인 시험법 셋업 • 잔류 DNA 확인 시험 - RT-qPCR을 이용한 잔류 DNA 확신 시험 수행 [DS 합성 및 정제 공정 수행] • Raw material을 이용한 DS 합성 연구 수행 • FPLC를 이용한 DS 정제 연구 수행 - AKTA Avant 기기를 이용한 Manual 및 Oligo-dT column을 이용한 정제 연구 수행 [DS (mRNA) 안정성 확인 시험 수행] • DS에 대한 장기 안정성 확인 시험 - Integrity 확인 시험을 통한 degradation 확인 - In vitro에서 단백질 발현을 통한 기능 검증 시험 수행 [연구자료 작성] • DS 합성 및 정제에 대한 연구 및 분석법 개발 보고서 및 protocol 작성

A biotechnology company focused on developing therapeutics for diabetic retinopathy and wound/pressure ulcer treatment, and conducting vaccine research using liposome-based delivery systems. The company developed an mRNA COVID-19 vaccine, which advanced to Phase 1/2 clinical trials in Australia. - I was participated in the internal development of an mRNA-based COVID19 vaccine. [English] mRNA Process & Platform Development — Associate Researcher (Jan 2020 – Sep 2022) I worked across both the Basic Research Team (COVID-19 Vaccine TF) and the Process Development Team, contributing end-to-end to the development of mRNA drug substance (DS), drug product (DP), and delivery systems. My role covered platform development, analytical method establishment, process scale-up, and technology transfer to CDMOs. * Key Responsibilities & Achievements A. mRNA DS Process Development: - Developed and optimized purification workflows using FPLC (ÄKTA Pure/Avant) and manual columns. - Performed in-process controls including pH, conductivity, and mRNA integrity (Fragment Analyzer). B. mRNA–Liposome DP Development: - Conducted formulation and scale-up studies; optimized lyophilization sequences for DP stability. C. mRNA Delivery System Development: - Designed cationic lipid–based liposomal carriers via thin-film hydration. - Evaluated delivery efficiency across multiple cell lines using luciferase assays. D. Vaccine-Related QC Method Establishment: - DS: mRNA integrity testing. - DP: Size and zeta-potential (DLS), and cell-based potency assays via flow cytometry. E. mRNA Platform Research: - Executed lab-scale mRNA synthesis and evaluation. F. Documentation & Tech Transfer: - Authored SOPs, BPRs, and development reports. - Successfully transferred DS and DP processes to CDMOs (BMI Korea, Microbial Validation Center) and provided troubleshooting support.