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Pyxant Labs Inc.

Colorado Springs, Colorado, US

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... Show more »

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.

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Biomarker Analysis
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LC-MS/MS
Quality Assurance
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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... Show more »

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).

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LC-MS/MS
Liquid chromatography tandem mass spectrometry
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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... Show more »

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.

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Bioanalytical Assays
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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.

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.

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Bioanalytical Assay Development and Optimization
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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... Show more »

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.

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Biomarkers
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Product Development, Testing, and Packaging
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Drug Discovery & Development
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Specialized Laboratory Services
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Mass Spectrometry
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Bovine
Guinea pig
Mouse
Pig
Rat
Dog
Rhesus Monkey
Horse
Mini Pig
Cat
Oncology
Obesity & Diabetes
Cardiovascular
Whole blood
plasma
CNS/Neurology
Thrombocytopenia
Perkin Elmer SCIEX API5000
Frozen Tissue
Tissue
Diabetes
cardiovascular
endocrine
dermatology
Oncology
Respiratory Diseases
Normal Human tissue
Inflammation
Dermatology
Endocrinology
Gastroenterology
Ophthalmology
Gastroenterology
Ophthalmology
Respiratory
Metabolic Disease
inflammation
Metabolic disorders
Fresh Tissue
AB Sciex API4000
WATSON
Neurological Diseases
CNS/neurology
monkey
Liquid Chromatography
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Drug Development
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Contract Research
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Chromatography
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Bioavailability and Bioequivalence Studies
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Laboratory and Facility Management Services
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Pharmacology & Toxicology
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Analytical Chemistry Services
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Product Quality Control
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Spectroscopy
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Chemistry and Materials
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ADME/DMPK Studies
Drug Metabolism and Pharmacokinetics
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Liquid Chromatography Coupled Mass Spectrometry Methods
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Project Management, Consulting, & Support Services
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Bioanalysis
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Experimental Design
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