endotoxin testing

bioMérieux is a world leader in in vitro diagnostics, founded in 1963, fulfilling the vision of the Mérieux family to improve health. The company provides diagnostic solutions for clinical, food safety and quality, and pharmaceutical quality control applications, helping protect consumer health and support informed care decisions.

customer technical supportenvironmental monitoringmass spectrometry (MALDI-TOF)microbial detectionmicrobial identificationmultiplex PCRmycoplasma testingsterility testing

Capital BioLabs is a QC microbiology testing laboratory headquartered in Rockville, MD, providing comprehensive microbiological testing services with an emphasis on communication and on-time delivery. The lab offers compendial testing supporting product development, validation, and regulatory compliance, and combines the customer service of a local laboratory partner with the solutions of a national provider.

bioburden testingcleaning validation studiescompressed air and gas sampling and testingcritical water sampling and testingdisinfectant efficacy qualification testingenvironmental monitoringGMP cleaning servicesmicrobial challenge studiesmicrobiological testingon-site sample collectionstaff augmentationsterility testingutility monitoring

Cell Therapy Tools provides tools, reagents, and services for cell therapy, including convenient kits for separation of platelet-rich plasma from whole blood. The company operates a certified cGMP facility producing autologous and allogeneic cell products, and offers mobile PRP and laser-activated PRP services in Orange County and Los Angeles. It uses patented low level laser activation technology and automated devices for laser activation of cell products and body fluids.

cGMP manufacturinglow level laser activationmobile servicesMSC bankingmycoplasma testingsterility testing

Clongen Laboratories is a CLIA-certified and CAP-accredited specialty laboratory founded in 1999 by Dr. Ahmed Kilani, with a facility in Gaithersburg, Maryland. It has three core divisions: Clinical Diagnostics for Infectious Diseases, Contract Research, and Veterinary Testing. Its clinical menu includes more than 250 molecular assays using PCR, real-time PCR, and DNA sequencing to identify human and animal pathogens.

cell bankingcustom assay developmentDNA sequencingGLP-compliant lot release testingmicrobial identificationmycoplasma eliminationPCRReal-time PCRsterility testing

Cook MyoSite, Inc., a subsidiary of the Cook Group, was established in 2002 to pioneer advancements in cellular technologies. The company is dedicated to commercializing muscle cell therapies and advancing muscle cell technologies, developing autologous muscle-derived cell (AMDC) technologies and the investigational iltamiocel platform. It operates laboratories and cleanroom facilities in Pittsburgh, PA, and offers custom cell solutions and contract research services.

assay developmentcell preservationcleanroom ISO 7 and ISO 5gene expression assaysGMP cell manufacturingmycoplasma assayprocess developmentQC analytical testingsterility testingTechnology transfer

D and D Laboratory, LLC is a 100% veteran-owned small business founded in 2004 by Alan Davis that specializes in water testing services for dialysis and sterile processing in healthcare facilities. It is ISO/IEC 17025:2017 accredited and helps facilities meet AAMI, ISO, and CMS-referenced standards, serving federal agencies including the VA and Department of Defense.

colony count testingconductivity testingICP-MS trace metals analysision chromatographyLAL testingpH testingsample collection kitstotal organic carbon testingwater testing

Dendreon is a commercial-stage biopharmaceutical company and end-to-end provider of manufacturing services for the cellular therapy market. It was the first company to successfully develop and commercialize an immunotherapy made from a patient's own cells, gaining FDA approval for PROVENGE (sipuleucel-T) in 2010, which has been prescribed to nearly 40,000 men with advanced prostate cancer.

apheresis managementautologous and allogeneic cell therapy manufacturingcell-based potency assayscellular therapy manufacturingcGMP manufacturingclinical and regulatory supportFlow Cytometrylogistics and delivery of time-critical therapiesPCRprocess and analytical developmentquality control testing