Bioactivity and Potency Testing
바이오의약품의 품질, 안전성, 효능을 평가하기 위한 생물활성 및 역가 시험 서비스 GMP 기준에 따른 in vitro 및 in vivo 생물학적 분석 수행 방법 개발, 검증, 이전, 최적화 및 로트 방출 시험 지원 혁신 신약과 바이오시밀러 간의 비교 가능성 평가 제공 ICH 가이드라인에 부합하는 포괄적 바이오어세이 솔루션 제공
Charles River · Bioactivity and Potency Testing
Bioactivity & Potency Testing
Potency determination is essential for regulatory submission and lot release of all biopharmaceutical products. Therefore, bioassays are central and critical for product development and manufacturing. These assays ensure the continued quality, safety, and efficacy of biopharmaceutical products, and confirm the biocomparability between innovator and biosimilar products. To achieve this, assays must be reliable, standardized, and relevant to the product’s mode of action.
Bioactivity & Potency Determination Assay
With extensive experience in establishing, validating, and conducting routine bioassays to GMP standards, Charles River provides a comprehensive array of both in vitro and in vivo bioassays for various biologically active molecules.
Our full range of services for bioassay development includes:
- Method development
- Method transfer
- Method optimization
- ICH-compliant method validation
- Lot release testing for drug substance and drug product
- Stability testing
- Accelerated stress condition testing
- Comparability testing between innovator and biosimilar biological products
Available Bioassay Types
제품 스펙
| 항목 | 내용 |
|---|---|
| 제품명 | Bioactivity and Potency Testing |
| 공급업체 | Charles River |
| 적용 분야 | Biopharmaceutical product development & manufacturing |
| 시험 유형 | In vitro / In vivo bioassays |
| 규격 기준 | GMP, ICH-compliant |
| 주요 서비스 | Method development, validation, lot release, stability, comparability testing |
Charles River 상품 둘러보기
전체보기
문의
0개 · 배송·재고 문의는 실시간 상담이 빠릅니다아직 등록된 문의가 없어요.