지난 한 세기 동안 ATCC는 신뢰할 수 있는 표준 절차와 최고의 시설들을 활용하여 다양한 생물학 자원들을 제작하고 보존하여 cell banking & storage의 선구자 역할을 해왔습니다.
최근 ATCC는 current Good Manufacturing Practices/Good Tissue Practices (cGMP/cGTP)를 인증 받아 세포 개발 초기부터 master/working cell back 생산까지 다양한 단계에 걸친 서비스 지원이 가능하게 되었습니다. ATCC cGMP biorepository 전문가가 cell bank의 보안과 완전 무결함을 위해 각 생물 자원의 특성을 파악하고 제품의 패키징, 저장 및 분양에 대한 풀서비스를 지원 합니다.
ATCC cGMP/cGTP Cell Banking 서비스로 biological material을 매번 직접 제작해야 하는 수고로움과 시간 및 비용을 아끼고, 잠재적으로 발생할 수 있는 각종 위험을 줄여 보세요. ATCC의 오랜 경험, 엄격한 품질 관리에 대한 신뢰와 명성을 통해 신약품 개발과 연구에 대한 확신을 얻을 수 있습니다.
cGMP AND cGTP CELL BANKING
- 21 CFR 600, 610, Good Manufacturing Practices (cGMP)
- 21 CFR Part 1271, Good Tissue Practices (cGTP)
- Mammalian and stem cells
- Primary cell derivation and expansion
- Over 5,000 cell lines available from ATCC’s fully authenticated
collection -or- use your own proprietary cells - Custom-built, designated cell processing suites
- Healthy cells and cells derived from diseased tissues
- Master and working cell banks (MCB and WCB)
cGMP BIOREPOSITORY
- ISO 9001:2008, cGMP-compliant
- LN₂, -80°C, -20°C, and 2-8°C storage available
- Cell, microbe, protein, and nucleic acid storage options
- Safe segregation of biological materials
- Cold-chain support and management
- On-call, after-hours personnel; 24/7 temperature monitoring
- Direct quality oversight of all unit entry and retrieval activities
cGMP Project를 ATCC와 함께 해야 하는 이유
| What can ATCC cGMP services offer | How this directly benefits your program |
| Nearly 100 years of cell culture and banking expertise | Our longevity and stability equates to security and peace of mind |
| Purpose-built cGMP-compliant suites | Full traceability and thorough documentation according to FDA regulations; capacity to run multiple projects simultaneously Reduced risks and associated costs of failed batches Complete transparency and trust |
| Highly-trained and experienced professional technicians | Our competence and attention to detail reduces the occurrence of errors |
| Rigorous quality control testing | Confidence that your product will meet the highest clinical standards |
| Broadest selection of fully authenticated bioproduc- tion cell models | Reduced risks associated with cross-contamination or misidentification |
| Master and working cell banking capabilities | Support from early to late stage clinical development |
| Short- and long-term cold chain storage | Consistent temperature distribution to preserve and protect invaluable specimens |
| Continuous validated temperature monitoring | Ensures the stability and integrity of stored cell banks |
| Extensive distribution network in 150 countries | Have your material sent where you need it when you need it |
