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cGMP Facility
Our cGMP operations are performed in 5 dedicated, individually isolated, qualified clean rooms with electronic access control and continuous monitoring. Each ISO 7 cleanroom is equipped with ISO 5 biological safety cabinet(s), CO2/humidity controlled and remotely monitored incubators, and centrifuge. The cleanrooms can be individually configured and qualified with equipment specific to your process requirements, such as automated wash and separation units, cell sorters, bioreactors, filling equipment, etc.
Quality Control tests for cGMP projects are performed in a spacious, tightly access-controlled laboratory with dedicated and validated QC equipment such as automated cell counters, flow cytometer, ELISA plate reader, and qPCR among other equipment and instruments to support cell-based assays, safety testing, and a separate room for incubation of environmental monitoring samples.
In support of cGMP manufacturing, we have dedicated, controlled and monitored GMP storage areas with a range of storage temperatures from vapor phase LN2, -80°C, -20°C, 2-8°C, and controlled room temperature, as well as areas for receiving and quarantine of incoming materials prior to release. Released materials flow to a kitting room where their packaging is cleaned and assembled in kits for each custom project before passing-through to the cleanroom suites.
Our cGMP facility and operations are managed according to FDA and ICH regulations and guidance for cell and gene therapy manufacturing using a validated electronic quality management system (eQMS) and an automated monitoring and alert system to track environmental conditions in facilities and equipment, as well as room pressure differentials. Our facility is licensed by the California Department of Public Health, and our quality systems have been certified under ISO:13485 since 2017.
We have plans and space available to grow our cGMP operations to include 5 additional, EMA Annex 1 compliant cleanrooms, along with additional cGMP QC and materials management space.
Contact us to learn how we can support your GMP clinical manufacturing project!
CRO and Research-Grade Production Facility
Separate from our cGMP operations, our CRO and research grade production operations occur across multiple laboratories (~10,000 ft2) equipped for cell culture, molecular biology, analytical testing, controlled storage, and shipping. Our facility in Silicon Valley has a strong track record with over 15 years and thousands of successfully-completed projects supporting cell and molecular biology researchers and product developers from leading companies, prestigious academic institutions, and federal and state standard-setting bodies in the USA and around the globe.
Cell biology laboratories house equipment such as biosafety cabinets, electroporation systems, CO2 incubators, centrifuges, fluorescence imaging microscopes, FACS instruments, dry and water baths, etc. to support research production and analytical operations. Our high-throughput automation system for gene editing includes an imaging system and Hamilton liquid handler/colony picker.
Our molecular biology labs include 30 benches dedicated to molecular biology work. The laboratories have all the necessary equipment and tools including NGS, ddPCR, qPCR, gradient PCR, electroporators, centrifuges, gel electrophoresis and imaging systems, spectrophotometers, freezers and refrigerators.
US Animal Facility
Applied StemCell’s animal operations and expert team are based in facilities and vivariums operated by the Oklahoma University Health and Science Center (OUHSC) with veterinary oversight by the OUHSC Division of Comparative Medicine. Protocol review and approval is performed by the OUHSC Office of Animal Welfare Assurance, and program oversight by the OUHSC Institutional Animal Care & Use Committee (IACUC). The facility is registered with the United States Department of Agriculture (USDA), Animal and Plant Inspection Service (APHIS), Animal Care (AC) as a federally approved research facility, assured through the NIH Office of Laboratory Animal Welfare (OLAW) and accredited through AAALAC, holding full accreditation status since 1973.