Capability
Microbiology Testing CDMOs
Compare CDMOs with GMP microbiology laboratory capabilities for sterility testing, endotoxin analysis, bioburden, and environmental monitoring.
157 companies listed
About Microbiology Testing
Microbiology testing ensures pharmaceutical products are free from harmful microorganisms and endotoxins. For sterile products (injectables, ophthalmic), sterility testing and endotoxin analysis are critical release tests. For non-sterile products (oral, topical), bioburden limits and specified organism absence testing protect patient safety.
Environmental monitoring is the ongoing surveillance component of microbiology. CDMOs must continuously monitor manufacturing areas for viable and non-viable particulates, surface contamination, and personnel contamination. Trending environmental monitoring data provides early warning of contamination control issues before they affect product quality.
Companies (157)
VelaLabs (Tentamus Group)
Austria
VelaLabs GmbH, a Tentamus Group company, is an Austrian GMP/GLP-certified contract analytical laboratory based in Austria. They provide analytical testing services for biologics (ATMPs, biopharmaceuticals, originator products, biosimilar candidates, biosimilars, blood and blood components, vaccines), chemicals, and excipients from early development (non-clinical, clinical) through market release testing. They offer GMP-compliant storage facilities and all types of microbiological and sterility analyses. They are GLP certified, GMP certified, GCLP-compliant, and FDA-approved. They recently announced a strategic partnership with EarlyHealth Group to support biological drugs development. They are a contract research laboratory (CRO), not a drug manufacturer.
Analytical ServicesMicrobiology TestingMethod Development & Validation
A
Advanced Analytical Testing Laboratories
United States
Advanced Analytical Testing Laboratories (AATL / AATS) is an FDA-registered contract testing laboratory located in New Jersey and Rancho Cucamonga, California. They provide analytical testing, method development and validation, stability studies, microbiology testing, and R&D services for pharmaceutical, nutraceutical, and dietary supplement products. They comply with cGMP, USP, and ISO 17025 standards.
Frequently Asked Questions
What are the core microbiology tests for pharmaceutical products?+
Core tests include: sterility testing (USP <71> or equivalent), bacterial endotoxin testing (LAL or rFC, USP <85>), bioburden testing (USP <61>/<62>), antimicrobial effectiveness testing (USP <51>), environmental monitoring (air, surface, and personnel sampling), water system monitoring (TOC, conductivity, microbial limits), and growth promotion testing for culture media.
What is the difference between LAL and rFC endotoxin testing?+
LAL (Limulus Amebocyte Lysate) is the traditional endotoxin test using horseshoe crab blood extract. rFC (recombinant Factor C) is the synthetic alternative that does not require animal-sourced reagents. Both are accepted by FDA and EMA, though rFC is gaining adoption for ethical and supply chain sustainability reasons. CDMOs offering both methods provide flexibility for sponsors with different preferences.
Need help finding the right CDMO?
Our AI Matchmaker analyzes your project requirements and matches you with qualified manufacturing partners. Free for buyers.
