Capability
Microbiology Testing CDMOs
Compare CDMOs with GMP microbiology laboratory capabilities for sterility testing, endotoxin analysis, bioburden, and environmental monitoring.
158 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 (158)
Veeda Lifesciences
India
Veeda Lifesciences (formerly Veeda Clinical Research) is a tech-driven global CRO headquartered in Ahmedabad, India with presence in 9 countries and sites across 26 geographies. They rebranded in January 2025 and now operate through four Strategic Business Units: Clinical Trials, Healthy Volunteer Services, Biopharma Services, and a fourth unit. Services include pre-clinical research, bioanalytical testing, clinical development for generics/innovators/biotherapeutics, real-world evidence, regulatory affairs, medical writing, pharmacovigilance, and data science. They have 2,100+ employees and are transitioning to a CRO-CDMO model per recent announcements, though their current core business remains contract research. Specializations include hemato-oncology, monoclonal/bispecific/trispecific antibody development, and multiple myeloma trials.
Analytical ServicesMethod Development & ValidationStability Studies
VelaLabs (Tentamus Group)
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.
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