Pyxant Labs Inc. is a high end, client-centric bioanalytical CRO located in Colorado. We have been providing GLP expertise since 1989. We conduct expert bioanalysis for PK/TK samples generated through discovery, pre-clinical, and clinical development programs. By using technical and regulatory expertise, we enable our biotech/pharma customers to bring medicines to market faster. With over 1,200 FDA studies and five successful FDA audits to date, we ensure development success with minimal risk and maximum value. Realizing that analytical results are integral to our clients’ success, providing the highest quality bioanalytical support is our specialty. Our mass spectrometry platform consists of top-end equipment platforms, including Applied Biosystems API 5000, 4000, and 3000 LC-MS/MS instruments that are operated by technical staff of the highest expertise. Our success is built on customer service-oriented technical support, fast turnaround, and truly independent study management, which provides an overall successful collaboration with our clients.
Pyxant Labs offers leading bioanalytical capabilities for the assay of small molecule, large molecule, and RNA therapeutics. Our platforms include LC/MS-MS and hybridization assays for both non-GLP and regulatory development studies for serum, plasma, and a wide range of tissues.
Our experience includes the development and regulatory validation of LC/MS-MS assays for oligonucleotide therapeutics in tissues. Pyxant Labs has successfully applied our LC/MS-MS platform (SCIEX 4000 and 5000 tandem mass spectrometers) for the study of these compounds in the most difficult tissue scenarios, including GLP liver and lung assays for regulatory development studies.
Our RNA therapeutics bioanalytical platforms include the following equipment, all validated for GLP studies.
Pyxant Labs also is leading the advancement of state-of-the-art bioanalytical assay technologies for RNA therapeutics through our active development of MS-MS capabilities.
Our in-house QA department assures the integrity of all the data we generate and of all the reports we publish. For analytical studies, we often write protocols on behalf of sponsors, provide study direction for laboratory projects, and write progress reports and final reports. We provide reports in a wide range of paper formats as well as electronic submission formats including MS Word (.DOC) and Adobe Acrobat (.PDF).
Provide bioanalytical support for non-GLP and GLP PK/PD, metabolism and toxicology investigations. Our experience ranges from exploratory PK through Phase III multi-center clinical trials.
Develop bioanalytical methods for pharmaceutical active ingredients, metabolites, and adjuvants in multiple matrices to the highest regulatory standards. We support pre-clinical and Phase I – III clinical studies, as well as post market surveillance.
Validate analytical and bioanalytical methods to FDA GLP 21CFR§58 and CDER guidance which can include comprehensive evaluations of accuracy, precision, repeatability, ruggedness, freeze-thaw, and stability.
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