Pyxant Labs Inc.

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).

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.

• TECAN Infinite M200 UV/fluorescence 96-well plate reader, and related shakers and washers
  
• Precellys Model 24 tissue sample extractor
  
• Applied Biosystems API 5000 and API 4000 LC/MS-MS systems
  
• Waters AcQuity UPLC system
  
• TOMTEC Quadra 3 automated sample preparation system
  
• Symbiosis Pharma online extraction system
  

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.

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.

Method Development:
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.

Method Validation:
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.