Pyxant Labs provides industry-leading GLP bioanalytical services to pharmaceutical companies developing new drugs for lives in need.
Our Data for Life® mantra celebrates our participation in an industry which saves lives. We fulfill an essential role in the drug development process. We have developed seminal capabilities which in the past directly supported cures for hepatitis, fundamental understanding of Alzheimer’s Disease, antiviral therapeutics for HIV, antisense therapeutics, and now therapeutics for SARS-CoV-2.
Pyxant Labs is a leading bioanalytical CRO in North America. We provide bioanalysis for all stages of the drug development process: discovery to PK/TK to IND-enabling GLP toxicology studies through Phase III clinical development. Using advanced sample preparation techniques and the latest mass spectrometry capabilities, Pyxant Labs develops and validates bioanalytical assay methods to stringent FDA and international regulatory requirements. Such rugged and reliable assays eliminate rework and help biotech and pharmaceutical companies to minimize regulatory challenges and reduce time to NDA approval. These capabilities derive from experience spanning 1,000,000 sample assays, 800 FDA studies, six successful FDA audits, and hundreds of client regulatory audits.
Pyxant Labs scientists and program managers with average bioanalysis experience exceeding 20 years enable industry-leading performance.
- 100% of standard discovery PK data delivered within 48 hours
- Assays encompass more than 140 types of biological tissues, in addition to plasma, urine, cerebral spinal fluids, and other biofluids
- Bioanalysis of more than 550 unique analytes includes complex bioanalytical assays for innovative therapeutic molecules, including RNA therapeutics, nucleoside antivirals, protease inhibitors, peptides, and large-molecule drug delivery mechanisms
Innovative Collaboration
Pyxant Labs commenced support for a leading RNA therapeutics development company of an early-stage toxicology program which required the assay of lipid nanoparticles (LNPs) for the delivery of micro-RNA payloads. LNPs are an innovative delivery mechanism of great interest to biotechs developing RNA therapeutics. Within three months, we developed an assay for the LNP, which we applied to discovery-stage development and subsequently progressing into preclinical GLP tox studies. The program currently is advancing into first-in-human clinical trials. The client has awarded contracts to Pyxant Labs to provide bioanalytical support through their clinical development program. A VP at this company sought out our CEO during a site visit to emphasize that “Pyxant Labs’ support is an enabling factor for our development program,” without which we might not have been able to satisfy FDA’s safety assessments.
Founded in March of 2000, Pyxant Labs is an industry-leading regulatory bioanalytical CRO. Our exclusive bioanalytical focus, forward client service, superior science, and regulatory leadership deliver on-time support from drug discovery through Phase III clinical development. Our experience spans 1,000,000 sample assays and 6 successful FDA inspections.
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Year Founded: 2000 Founded By: Maurice Gaubatz
