Contamination & Impurity Testing
바이오 의약품의 안전성을 확보하기 위한 오염 및 불순물 시험 서비스 미코플라스마, 세균, 바이러스 등 다양한 오염원 검출용 시험 제공 단백질 A, DNA, Tween, PEI 등 공정 잔류 불순물 분석 지원 제품 맞춤형 시험법 개발 및 밸리데이션 가능 규제 제출용 CMC 요건 충족을 위한 품질 보증 서비스
Charles River · Contamination & Impurity Testing
Contamination & Impurity Testing
From preclinical lots through routine bulk harvest testing of clinical and marketed batches, contamination testing helps ensure the safety of your biologic before it is released for use in animals and humans. The characterization of the purification process and testing for possible impurities are also key parts of the chemistry and manufacturing controls (CMC) section of regulatory filings.
Contamination Detection Assays & Impurity/Residual Testing Services
Charles River offers a portfolio of compendial assays for the detection of mycoplasma and bacterial contaminants and also in vivo, in vitro, and biochemical viral detection assays. Our experts can design and develop the appropriate testing plan for your biologic, with a selection of available and customized assays that suit your specific needs.
In support of “quality by design” for any process, testing of residual process impurities is an integral step. We support testing of all process stages for impurities such as residual Protein A, DNA, Tween, IPTG, TRIS, PEI, endotoxin, and host cell proteins. In addition to generic methods, we offer transfer or method development and validation for customized, product-specific methods.
주요 시험 항목
| 구분 | 시험 내용 |
|---|---|
| 오염 검출 | 미코플라스마, 세균, 바이러스 검출 (in vivo, in vitro, 생화학적 분석) |
| 불순물 분석 | Protein A, DNA, Tween, IPTG, TRIS, PEI, endotoxin, host cell protein 등 |
| 시험법 제공 | 공정별 잔류 불순물 시험, 맞춤형 시험법 개발 및 밸리데이션 |
| 적용 분야 | 전임상, 임상, 시판용 배치의 품질 관리 및 규제 제출용 CMC 자료 지원 |
Charles River 상품 둘러보기
전체보기
문의
0개 · 배송·재고 문의는 실시간 상담이 빠릅니다아직 등록된 문의가 없어요.