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SK 세포배양 독감백신 '스카이셀플루' 올해 첫 출하 - 바이오스펙테이터

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SK 세포배양 독감백신 '스카이셀플루' 올해 첫 출하

입력 2019-08-30 08:22 수정 2019-08-30 09:07

바이오스펙테이터 장종원 기자

SK바이오사이언스, 안동 L하우스에서 본격 출하..바이러스 변이가능성 낮아 예방효과↑

▲SK바이오사이언스 직원이 생산이 완료된 스카이셀플루를 검수하고 있다. SK바이오사이언스 제공.

SK바이오사이언스의 세포배양 독감백신 '스카이셀플루'가 올해 첫 물량 출하를 마쳤다.

SK바이오사이언스는 스카이셀플루가 시판을 위한 마지막 관문인 국가출하승인을 받고 경북 안동 백신공장 L하우스에서 본격적인 출하에 들어갔다고 30일 밝혔다.

SK바이오사이언스가 올 연말과 내년 초 국내에 공급할 독감백신은 약 500만 도즈(1도즈=1회 접종량) 물량으로 내달부터 전국 병의원으로 공급이 시작될 예정이다.

스카이셀플루는 국내 유일 세포배양 독감백신으로 최첨단 무균 배양기를 통해 생산돼 항생제나 보존제의 투여가 불필요하다. 또 기존 백신 대비 생산 기간이 짧고 효율이 우수해 신종플루와 같은 독감 대유행 상황에 신속하게 대처하는 것이 가능하다.

최근엔 세포배양 독감백신이 유정란배양 백신에 비해 배양과정에서 발생할 수 있는 바이러스 변이 가능성이 낮아 더 높은 예방효과를 제공한다는 조사결과가 국내외에서 잇따라 발표되기도 했다.

미국 FDA(식품의약품)와 CDC(질병관리본부)가 2017-2018 시즌 독감백신의 상대적 효과를 분석한 자료에 따르면 세포배양 4가 독감백신은 유정란 4가 독감백신보다 11% 높은 예방효과를 보였다. WHO(세계보건기구)가 지난해 2월 실제 유행하는 A형 H3N2 독감 바이러스와 배양된 백신 바이러스를 비교해 조사한 결과에서도 세포배양 바이러스는 91%, 유정란배양 바이러스는 44%의 일치율을 보인 것으로 확인됐다.

SK바이오사이언스는 이 같은 장점을 바탕으로 지난해 2월 스카이셀플루의 세포배양 생산 기술을 글로벌 백신 기업 사노피에 수출한 바 있다. 올해 4월엔 세포배양 독감백신으로는 세계 최초로 WHO(세계보건기구) PQ(Pre-qualification, 사전적격성평가) 인증을 획득하기도 했다.

SK바이오사이언스의 이상균 안동공장장은 "본격적인 독감예방접종 시즌을 앞두고 시장에 제품을 공급하기 위한 모든 채비를 마쳤다"며 "국내 유일 세포배양 독감백신의 특장점을 앞세워 시장에서의 경쟁우위를 높여갈 것"이라고 말했다.

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