Accurate Microbial Identification Testing
Ensure your program stays ahead of huge risks, including time-consuming inventory recalls and jeopardized patient safety, with our microbial identification services. Our team has years of experience performing analytical testing on various drug substances, drug products, and medical devices. We apply the highest level of quality and attention to detail to your products to ensure that your microbial identification testing is successfully executed.
Types of Microbial Identification
With our state-of-the-art facilities and current Good Manufacturing Practices (cGMP), we offer comprehensive microbial identification solutions for isolates recovered from critical environments throughout the medical device, pharmaceutical, and biopharmaceutical industries.
Genotypic
Evaluates the use of conserved sequences, often DNA or RNA, within phylogenetically informative genetic targets to determine evolutionary relationships between organisms.
Proteotypic
Uses MALDI-TOF mass spectrometry to analyze species-specific ribosomal proteins.
Phenotypic
Identifies microorganisms through biochemical reactions, such as acid and salt tolerance, metabolism, fermentation, gram staining, and colony characterization.
Maldi-tof Microbiology
Automated self-cleaning, silent bench-top MALDI-TOF system with enhanced peak resolution, sensitivity, and performance.
If your Axcess® system should unexpectedly go out of service, send your samples to your local Accugenix® facility. Although the likelihood of this occurring is rare, we give you the ability to continue your operations and avoid manufacturing delays.
Our IT approach is purposely designed with multiple redundancies to protect your data and to ensure continuity of service 24/7.
Workflow analysis has shown that one target plate containing 96 spots each can yield results in 15 minutes, compared to other MALDI-TOF instrumentation that can take up to 45 minutes for the same workload or phenotypic systems that can take up to 18 hours of incubation time for biochemical reactions to occur.
Integrated Laboratory Services
When your team needs additional support, our scientists are ready. Our state-of-the-art facilities and highly trained experts add power to your project.
Additional Resources
Pace® is a registered facility with the U.S. Food and Drug Administration (FDA), demonstrating our commitment to meeting regulatory requirements for quality and safety in the industries we serve.
Pace® holds a registration with the Drug Enforcement Administration (DEA), allowing us to handle controlled substances and support the specific needs of our clients in regulated industries.
Pace® adheres to current Good Manufacturing Practices (cGMP), ensuring that our laboratory facilities and processes meet the highest quality standards set by regulatory authorities for the pharmaceutical, biopharmaceutical, and medical device industries.
Pace® is accredited to ISO/IEC 17025, the international standard for competence in testing and calibration laboratories, validating our technical competence and commitment to delivering accurate and reliable results.