sterility testing

Afton Scientific is a sterile contract manufacturing organization (CDMO) providing aseptic manufacturing and fill-finish services for biologics and small molecules, along with pharmaceutical laboratory services including analytical testing, stability studies, quality control, and validation and compliance testing. The company has over 20 years of experience in sterile injectable manufacturing and operates FDA-inspected facilities with a mature Quality Management System.

analytical testingaseptic processingContainer Closure Integrity Testing (CCIT)endotoxin (LAL) testingenvironmental monitoringfill-finish operationsGCHPLCmethod development and transfermicrobiological testingparticulate matter analysisquality control testingstability studiessterile fillingUV-Vis Spectroscopyvalidation and compliance testingVisual Inspection

Compass Biomedical is a research and development company focused on enabling cell and cancer therapies. It provides human platelet lysate products under the PLUS™ brand and offers contract research and manufacturing services supporting cell, blood, and tissue-based products from early proof-of-concept through process development, GMP manufacturing, and packaging.

biochemical analysiscustom assay developmentfill/finishFormulation OptimizationGMP manufacturinghematology panelslyophilizationpackagingpotency assaysprocess developmentScale uptechnology transferviral safety 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 supportendotoxin testingenvironmental monitoringmass spectrometry (MALDI-TOF)microbial detectionmicrobial identificationmultiplex PCRmycoplasma 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 testingendotoxin testingenvironmental monitoringGMP cleaning servicesmicrobial challenge studiesmicrobiological testingon-site sample collectionStaff augmentationutility 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 manufacturingendotoxin testinglow level laser activationmobile servicesMSC bankingmycoplasma 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 sequencingendotoxin testingGLP-compliant lot release testingmicrobial identificationmycoplasma eliminationPCRReal-time PCR

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 5endotoxin testinggene expression assaysGMP cell manufacturingmycoplasma assayprocess developmentQC analytical testingtechnology transfer

HelioWave Technologies is a spin-out from Texas A&M University that develops rapid contamination and sterility testing solutions, including the HelioSAFE sterility detection system. Its technology uses microfluidic and lab-on-a-chip systems to detect contamination in as little as 30 minutes instead of 14 days, serving pharmaceutical, food safety, and everyday product applications.

contamination detectionlab-on-a-chip systemsmicrofabricationmicrofluidicsreal-time monitoring