Our quality product service solutions bridge the gaps between technology and patient care by providing custom-tailored cell therapy services, including:
- Contract Manufacturing
- Product & Process Development
- Consulting
- GTP Services
- National Distribution
Cell Therapy Links
Cell Therapy Regulatory Bodies:
United States Food & Drug Administration (FDA) Homepage
CBER (Center for Biologics Evaluation & Research)
CDER (Center for Drug Evaluation & Research)
Good Manufacturing Practice/QualitySystems
ORA (Office of Regulatory Affairs)
European Union Regulatory Body (EMEA)
National Institutes of Health (NIH):
National Institute of Standards & Technology (NIST)
International Conference on Harmonisation (ICH)
Canadian Health Protection Branch (HPB)
Japanese Ministry of Health, Labour and Welfare (MHLW)
World Health Organization (WHO)
21 CFR Part 11 Compliance
Cell Therapy Regulatory Reference Materials:
FDA Final Rule: Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approach
FDA/ORA References - 21 CFR Part 11
21 CFR 210 & 211: Good Manufacturing Practices (GMPs)
CBER Guidances/Guidelines/Points to Consider
Cell Therapy Related Associations:
AABB on Cellular Therapies
American Association of Immunologists (AAI)
American College of Cardiology (ACC)
American Heart Association (AHA)
American Society for Apheresis (ASFA)
American Society for Blood & Marrow Transplantation (ASBMT)
American Society for Gene Therapy (ASGT)
American Society for Hematology (ASH)
American Thoracic Society (ATS)
Biotechnology Industry Organization, Cell & Gene Therapy Committee (BIO)
Cell Therapy Transplant Society (CTS)
Foundation for the Accreditation in Cellular Therapy (FACT)
International Pancreas and Islet Transplantation Association (IPITA)
International Society for Cellular Therapy (ISCT)
International Society for Stem Cell Research (ISSCR)
National Marrow Donation Program (NMDP)
American Type Culture Collection
Cell Therapy Related Publications:
BioProcess International
BioProcessing Journal
Cell Therapy Blog - Industry News & Analysis
Cell Therapy News
Cytotherapy Journal
Genetic Engineering News
Regenerative Medicine Journal
