전통적인 신약 개발 과정.

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전통적인 신약 개발 과정

신약개발과정에서 HCS 시스템의 필요성 신규 타겟 발굴 및 검증 분야의 국제 경쟁력이 매우 취약함. Target Target Lead Lead Development Development Pre Pre - - Clinical Clinical Identification Identification Generation Generation Candidate Candidate Clinical Clinical High Innovative Genomics Substance Strategic New Drug Proteomics Outsourcing Candidate Alliance World World - - wide wide 경쟁력 경쟁력 Development Development Novel Novel Target identification Target identification & Validation & Validation Low 신규 타겟 발굴 및 검증 분야의 국제 경쟁력이 매우 취약함. Cell-based assay system 기술 분야의 경쟁력이 뒤쳐지기 때문임. 세계 각국에서는 새로운 assay system을 개발하여 HCS와 연계시키고 있음. 고유의 HCS 시스템기술을 개발하여 신약개발 경쟁력을 높여야 할 때임.

하이컨텐트 스크리닝(High Content Screening)이란? “살아있는 세포 또는 생체 내의 다양한 표적을 시간적, 공간적으로 분해능이 높은 고감도 형광 이미징을 기반으로 해서 복합적이고 기능적으로 스크리닝하는 기술” “Cell-Based Assay (세포기반분석)” Localization of an EGFP-Forkhead construct in Human osteosarcoma cell line, U2OS Green : EGFP-Forkhead constructure - Red : the cells counterstained with DRAQ5

HCS의 중요성 : 신약개발과정의 문제점 높은 Compound 탈락율 2,500,000 : 1 높은 신약개발 비용 Assay Development 2,500,000 Screening 10,000 Lead Optimization 250 높은 Compound 탈락율 2,500,000 : 1 Preclinical 10 높은 신약개발 비용 = $1.7 billion 긴 신약개발 기간 = 13년 Clinical 1 Drug

Cell-based Asaay/Screening HCS의 중요성 : 새로운 분석 기술의 필요성 HTS (High Throughput Screening) Driven by NUMBER Screening하는 Compound의 숫자를 극대화 In-vitro Single component 스크리닝 HCS (High Content Screening) Driven by DATA Screening을 통해 얻어지는 각 Compound의 바이오 데이터/정보의 극대화 In-vivo Multiplexing Cell-based Asaay/Screening

Multiplex, Live Cell-based Assay HCS의 궁극적인 목표 Assay Development Multiplex, Live Cell-based Assay And Screening Find Early to Save Time and Money !! Screening Lead Optimization Preclinical Clinical Drug

HCS Examples Intensity Module Translocation Module Granularity Module Colocalization Assays Protein Expression Reporter Gene Assays Viability Assays Nuclear Translocation Membrane Translocation Membrane Ruffling Cell Signaling Assays Cell Movement Assays Receptor Internalization CypHer Technology Transfluor Technology Endosome Trafficking Toxicity Assays

HCS용 바이오컨텐트 요소기술 핵심 요소기술 세포기반 분석법 시약 및 세포주 바이오 에세이 이미징 소프트웨어 Drug candidate Ligands/Receptors/Cells 세포기반 분석법 Cell line Fluorescence labels/Chemicals 시약 및 세포주 Real-time Live Cell/Organism Imaging 바이오 에세이 이미징 Image Processing Software Image Database Informatics 소프트웨어

HCS 시스템 Layout (예시) Detection System Liquid Handling System Cell Imaging & Analysis Control System HCS Well Stage HCS Well Loading System

선진 HCS 시스템 관련 주요 기업체 회사명 제품명 및 주요기능 판매가 (US$) 30-100만$ 40-50만$ 20-25만$ Amersham Biosciences (USA) IN Cell Analyzer 1000/3000 multiparameter, laser-based cellular imaging system 30-100만$ Cellomics ArrayScan:  high-throughput cell screening system, flourescent reagents and assays,co-marketed Carl Zeiss Ultra High Throughput Screening System 40-50만$ Atto Biosciences Pathway HT is an automated, confocal, real-time, single cell kinetic and endpoint imaging system 20-25만$ Molecular Devices (USA) Discovery-1:  visualize and analyze cell populations. Discovery TMA: for tissue microarrays, FLIPR: fluorescence imaging plate reader 20-30만$ Perkin Elmer Biosystems The ImageTrak™ is a versatile cellular imaging platform, for both kinetic and end-point read assays, and can be used for assay development, primary and secondary screening within the Drug Discovery process. 30-40만$