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바이젠셀, 세포치료제 ‘신규 GMP 시설’ 착공 - 바이오스펙테이터

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바이젠셀, 세포치료제 ‘신규 GMP 시설’ 착공

입력 2021-10-22 10:22 수정 2021-10-22 10:22

바이오스펙테이터 서윤석 기자

2644㎡(약 800평) 규모 GMP 시설..약 220억원 투입해 2022년 상반기 완공 목표

보령제약 관계사인 바이젠셀은 22일 세포치료제의 임상 가속화 및 상업용 대량생산을 위한 GMP시설을 착공했다고 밝혔다.

바이젠셀은 가산디지털단지내 더 리즌밸리 지식산업센터에 자리잡은 신규 GMP 시설은 2644㎡(약 800평) 규모로 조성되며 약 220억원이 투입될 예정이다. 연구시설까지 포함하면 4539㎡(약 1400평)에 이르는 규모다. 바이젠셀은 GMP시설을 오는 2022년 상반기 완공을 목표로 하고 있으며 첨단바이오의약품 제조업 허가, 세포처리시설 구축, 인체세포 등 관리업 허가까지 함께 완료할 예정이다.

바이젠셀에 따르면 신규 GMP 시설은 7개의 클린룸을 갖추고 있으며 자동화공정시스템을 도입해 대량생산이 가능한 것이 특징이다. 특히 유전자 치료제 연구를 위한 LMO(Living Modified Organisms, 유전자변형생물체) 시설도 함께 설계해 세포치료제를 연구 및 생산할 수 있다. 신규 GMP 시설은 면역항암제와 면역억제제를 비롯해 바이젠셀에서 개발 중인 모든 면역세포 기반의 임상시험용 의약품과 상업용 의약품 생산이 전부 가능하다는 설명이다.

김태규 바이젠셀 대표는 “세개의 플랫폼을 기반으로 한 다양한 파이프라인과 최첨단 GMP시설을 통해 세계 최고의 면역세포치료 전문기업으로 성장해 나갈 것"이라고 말했다.

한편 바이젠셀은 맞춤형 T세포 면역항암치료제 ‘바이티어’(ViTier)’, 범용 감마델타T세포 면역항암치료제 ‘바이레인저’(VR)’, 범용 면역억제치료제 ‘바이메디어’(ViMedier)’라는 세포치료제 플랫폼 기술을 보유하고 있으며 이를 바탕으로 6종의 세포치료제를 개발하고 있다.

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