Cellular Technology Limited (CTL) develops and manufactures standardized immune-monitoring tools centered on ELISPOT and FluoroSpot, including ImmunoSpot analyzers, assay kits and cryopreserved PBMC. Based in Shaker Heights, CTL has focused on these methods for more than 25 years and also operates a contract research laboratory for regulated immune-monitoring studies. Its in-house research program has produced more than 200 publications, while its laboratory can process up to 450 samples per week.
CLIA/CLEP Certification
Cell Viability Certification by ISBER
21 CFR Part 11 Compliance
Compliance program
FDA Bioanalytical Method Validation Guidance
Compliance program
GCP Compliance
Compliance program
GLP Compliance
Compliance program
GMP Compliance When Applicable
Compliance program
ICH Guidelines
Compliance program
California Clinical Laboratory License COS 00800918
Registration
Clinical Laboratory Improvement Amendments Certificate 36D1100176
Registration
Maryland Department of Health Medical Laboratory Permit
Registration
New York State Department of Health Clinical Laboratory Permit
Registration
Rhode Island Clinical Laboratory License LCO01323
Registration
Pennsylvania Department of Health Clinical Laboratory Permit
Registration
European Pharmacopoeia Ph. Eur. 2.6.30 MAT Framework
Compliance program
ISBERCELLVIABILITY
Quality certification
GCP
Quality certification
GLP
Quality certification
GMP
Quality certification
MARYLANDMEDICALLABORATORYPERMIT
Quality certification
NEWYORKSTATECLINICALLABORATORYPERMIT
Quality certification
EUROPEANPHARMACOPOEIA2630
Quality certification
Lifeline Cell TechnologyLifeline Cell Technology develops and manufactures purified primary human cells, stem-cell products, and optimized cell-culture media for laboratory research. Its founders helped introduce normal human cell systems more than 25 years ago, and the company now operates an 8,000-square-foot laboratory and administrative facility in Frederick, Maryland as a wholly owned subsidiary of International Stem Cell Corporation. Lifeline also supports researchers through scientist-led technical assistance and an international distributor network.FREDERICK, MD
Applied BioPhysics, IncFounded in 1991 by the inventors of Electric Cell-substrate Impedance Sensing, Applied BioPhysics manufactures ECIS® instruments and electrode arrays that monitor living cells in tissue culture in real time. Based in Troy, New York, the company applies biophysical research to cell research and drug discovery, with 95 percent of its products made at its U.S. facility. Its systems give researchers a label-free way to study cell behavior while maintaining active connections with the academic community that helped shape the technology.TROY, NY
Meso Scale Diagnostics, LLCRockville-based Meso Scale Diagnostics develops and manufactures immunoassay instruments, assay kits, reagents, and related services for measuring biomarkers in biomedical research and pharmaceutical development. Its S-PLEX platform extends that work to femtogram-per-milliliter sensitivity, enabling researchers to quantify very low-abundance proteins in biological samples. The company’s quality systems have been certified to ISO 9001:2015 and ISO 13485:2016, with the latter covering in-vitro diagnostic product design and development.ROCKVILLE, MD
Innovative Cellular TherapeuticsHeadquartered in Rockville, Innovative Cellular Therapeutics is a private clinical-stage biotechnology company developing cellular immunotherapies for solid tumors. Its proprietary CoupledCAR® platform underpins individually made CAR-T therapies, including the lead GCC19CART program being studied for relapsed or refractory metastatic colorectal cancer. Founded by Larry Lei Xiao and Zoe Zhao Wu, ICT combines more than 20 years of stem-cell, cell-therapy and gene-editing experience with FDA cellular-therapy review expertise.ROCKVILLE, MD