제목 :  마이크로바이옴 연구 기반 장내 세균 의료제품에 대한 고려사항   - 생균치료제(LBP)의 개발 및 평가 시 고려사항

 

금회는 "마이크로바이옴 연구 기반 장내 세균 의료제품에 대한 고려사항   - 생균치료제(LBP)의 개발 및 평가 시 고려사항"을  

전송드립니다.

 

목차와 서론을  소개합니다.

 

 마이크로바이옴 연구 기반 장내 세균 의료제품에 대한 고려사항 - 생균치료제(LBP)의 개발 및 평가 시 고려사항 -

Points to Consider for Gut Bacterial Products

Based on Microbiome Research

- Considerations for the Development and Evaluation of Live Biotherapeutic Products -

머리말···············································································································································7

서론··················································································································································9

1. 감염성 면역 질환 및 비면역 질환용 LBP의 개발 현황·············································································11

1.1. LBP가 개발 중인 주요 질환 분야(5~7)·······························································································13

1.2. FMT······································································································································13

1.3. LBP 개발시 애로사항···················································································································13

2. LBP 평가용 신기술·························································································································15

2.1. 분류 및 동정 기법의 최근 동향·········································································································15

2.2. 미생물 복합균주(microbial consortia) 특성분석 방법론의 동향·································································19

2.3. in silico 안전성 평가····················································································································25

2.4. 생체 외 분석법···························································································································29

3. 비임상시험····································································································································35

3.1. 약리시험(유효성 뒷받침 시험 등)······································································································35

3.2. 약동학시험·······························································································································35

3.3. 비임상 안전성시험·······················································································································37

4. LBP 제조(은행 구축) 및 품질 관리·····································································································41

4.1. 원료의약품 제조 및 세포은행 운영 방식·······························································································43

4.2. LBP의 특성분석·························································································································49

4.3. LBP의 규격 시험 및 허용 기준·········································································································51

4.4. 제형화 공정 개발························································································································53

5. 임상시험 시 고려 사항······················································································································55

  ▶서론은  다음과 같습니다.

 

서론

사람의 장관에는 수백 종의 세균이 서식하고 있으며, 약 100조 개의 세균(1~4)이 장내 마이크로바이옴을 형성한다.

이들 세균이 생성하는 각종 대사산물과 사람 장관과의 상호 작용을 통해 숙주인 사람의 면역 기능, 대사 활동 등 여러

생리적 기능에 영향을 미친다. 이는 세균이 인체의 건강 유지에 관여하고 있음을 나타낸다.

또한 일부 질병의 경우 환자의 마이크로바이옴 구성이 비정상적으로 나타나고, 장내 미생물총에 이상이 생기

면 다양한 질병이 발생할 수 있음이 밝혀졌다. 게다가, 건강한 사람의 분변 미생물총을 이식(Fecal Microbiota

Transplantation, FMT)하여 환자의 마이크로바이옴을 변화시키고 다양한 질병 치료에 도움을 줄 수 있다는 연구

결과도 있다.

그러나 분변 미생물총의 세균 종이 질병 치료에 효과가 있는지는 명확히 입증된 바 없다. 분변 미생물총의 효과를

긍정적으로 바라보는 연구 결과가 존재하나, 그 종이나 균주를 정확하게 동정한 사례도 없다. 따라서, 특별 관심 대상

세균 종을 동정하는 것이 바람직하다. 이러한 효과로 보건대 단일 또는 복수 종의 생균치료제(LBP) 요법을 질병 치료

에 활용할 가능성이 존재한다고 할 수 있다.

본 문서에는 각종 질병의 치료용으로 현재 개발 중인 LBP 관련 애로사항을 수록하였으며, LBP 치료제 개발 시 작용

기전 규명, 제조공정, 품질특성 분석, 전임상 및 임상시험 설계 등 고려하여야 할 점을 요약 수록하였다. 또한 LBP의

특성을 바탕으로 임상 환경에서 품질 및 안전성 평가를 실시할 때 유의할 사항을 서술하였다. LBP의 개발 속도가

빠르다는 점을 생각하면 이러한 문제들을 반드시 검토하여야 할 것이다. LBP에는 세균뿐 아니라 진균, 박테리오

파지도 들어있을 수 있으나, 여기서는 세균 제제만 다루기로 한다. 다만, 본 문서에 기재한 많은 기본 개념을 타 장내

미생물 종으로도 확장할 수 있을 것으로 보인다.

 

이하 원문 全文이 필요하신 분은 kimpj1@naver.com 김필주 기술사 에게 연락주시면 보내드리겠습니다.

 

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