[ATCC] cGMP & cGTP Cell Banking and cGMP Biorepository

세포 개발부터 저장까지 제공하는 ATCC

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. 

실험실

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
ATCC 실험실

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
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