Pyxant Labs is a bioanalytical contract research organization (CRO) that offers analytical research, development, and validation services to support early stage drug discovery, pre-clinical studies, and clinical trial sample analysis. Our capabilities include assays for small-molecules, antisense oligonucleotides, RNA therapeutics, gene therapy programs, and peptides in an extraordinarily wide variety of challenging biological matrices, such as plasma and different solid and liquid tissues including umbilical cord, gut slurry, and ocular tissues. We also assay custom biomarkers to both GLP and CLIA requirements.
We operate at a scale which enables a full range of mass spectrometry services alongside value-added personal service. Our customers appreciate the combination of leading science, fast response, and regulatory leadership for their bioanalytical development requirements.
Our specialized discovery team has the ability to issue data within 24 hours from the time of sample receipt. With our in-life partners, we are consistently able to provide an end-to-end service from dosing to data.
Our highly skilled and experienced scientists develop and validate customized methods within a diverse range of compound classes, as well as unique biological matrices, following guidance of various regulatory agencies including FDA (CDER, CVM), EMA, and Health Canada.
We conduct expert bioanalysis from discovery through clinical phase studies in varying compound classes, such as small molecules, RNA therapeutics (oligonucleotides), peptides, and anti-body drug conjugates (ADCs), in all biological matrices including plasma, urine, feces, and an extensive number of tissues.
Pyxant Labs Inc. has been actively supporting CVM registrations since 2006. Our scientists have industry‑leading expertise in method validation and sample analysis to support abbreviated new animal drug applications (ANADA) bioequivalence studies. Pyxant Labs Inc. has worked with over a dozen different animal health companies within the United States and Europe and has performed bioanalytical analysis on multiple ANADA approvals.
Pyxant Labs Inc. supports CVM clients from early development pilot studies to pivotal bioequivalence studies. Our scientists develop fit-for-use assays which can be used to quickly and accurately evaluate generic formulations against innovator drugs to determine if the drug product shows promise. Once pilot studies are complete, our bioanalytical assays move into method validation, and a complete regulatory package is submitted to the client for CVM review prior to conducting the pivotal bioequivalence study.
Pyxant Labs has expanded into high-resolution mass spectrometry (HRMS) with the recent acquisition of a Thermo Q Exactive Plus and its industry-leading high-resolution accurate mass (HRAM) capabilities.
In addition to our years of experience with LC/MS/MS, Pyxant Labs offers support for oligonucleotide testing using high-resolution mass spectrometry (HRMS) and hybridization-based LC-fluorescence.
Pyxant Labs offers unmatched scientific expertise in developing assays for an extensive number of unique tissues, including brain, lung, kidney, cornea, optic nerve, umbilical cord, spinal cord, and more, to provide data pertaining to target identification and biodistribution related DMPK and ADME projects. By developing specialized homogenization, stabilization, and extraction procedures, Pyxant Labs can accommodate a wide variety of our clients’ tissue bioanalysis needs. Developing and validating custom tissue assays is routine for our scientists, and our capabilities can serve a range of regulatory requirements, including FDA, EMA, CVM, VICH, and more. With the efficiency and execution of tissue bioanalysis performed at Pyxant Labs, you will be able to appropriately strategize the next steps in your drug development process from discovery through clinical work.
Please, contact us if your compound is not on this list.
|Atazanavir||Human Plasma||10.0 to 10,000 ng/mL||K2EDTA|
|ATRIPLA™ (Tenofovir, Emtricitabine, Efavirenz)||Human Plasma||5.00 to 5,000 ng/mL||K2EDTA|
|Bupropion||Human Plasma||0.0500 to 2500 ng/mL||K2EDTA|
|Hydroxybupropion||Human Plasma||0.0500 to 2500 ng/mL||K2EDTA|
|Capsaicin||Human Plasma||0.0500 to 50.0 ng/mL||K2EDTA|
|Clindamycin||Human Plasma||50.0 to 50,000 ng/mL||K2EDTA|
|Cyclosporine||Whole Blood||2.00 to 2000 ng/mL||K2EDTA|
|Darunavir||Human Plasma||10.0 to 10,000 ng/mL||K2EDTA|
|Dextromethorphan||Human Plasma||1.00 to 500 ng/mL||K2EDTA|
|Dextromethorphan||Human Urine||1.00 to 500 ng/mL||N/A|
|Dextrorphan||Human Plasma||1.00 to 500 ng/mL||K2EDTA|
|Dextrorphan||Human Urine||1.00 to 500 ng/mL||N/A|
|Digoxin||Human Plasma||100 to 50,000 pg/mL||K2EDTA|
|Digoxin||Human Urine||1.00 to 100 ng/mL||N/A|
|Fexofenadine||Human Plasma||2.00 to 6000 ng/mL||K2EDTA|
|Fluoxetine||Human Plasma||0.100 to 50.0 ng/mL||K2EDTA|
|Norfluoxetine||Human Plasma||0.100 to 50.0 ng/mL||K2EDTA|
|Gemfibrozil||Human Plasma||50.0 to 50,000 ng/mL||K2EDTA|
|Iltraconazole||Human Plasma||1.00 to 1000 ng/mL||K2EDTA|
|Ketoconazole||Human Plasma||20.0 to 10,000 ng/mL||K2EDTA|
|Midazolam||Human Plasma||0.100 to 300 ng/mL||K2EDTA|
|Midazolam||Human Plasma||0.100 to 100 ng/mL||K2EDTA|
|α-Hydroxymidazolam||Human Plasma||0.100 to 100 ng/mL||K2EDTA|
|Montelukast||Human Plasma||5.00 to 1,000 ng/mL||K2EDTA|
|Montelukast 1,2-diol||Human Plasma||5.00 to 1,000 ng/mL||K2EDTA|
|Moxifloxacin||Human Plasma||25.0 to 5000 ng/mL||Na Hep|
|Mycophenolic Acid||Human Plasma||2.50 to 2500 ng/mL||K2EDTA|
|Mycophenolic Acid-β-D-Glucuronide||Human Plasma||25.0 to 25,000 ng/mL||K2EDTA|
|Norethisterone||Human Plasma||50.0 to 15,000 pg/mL||K2EDTA|
|Ethinylestradiol||Human Plasma||5.00 to 1500 pg/mL||K2EDTA|
|Omeprazole||Human Plasma||1.00 to 1000 ng/mL||K2EDTA|
|Raltegravir||Human Plasma||10.0 to 10,000 ng/mL||K2EDTA|
|Scopolamine||Human Plasma||0.00200 to 2.00 ng/mL||K2EDTA|
|Sildenafil||Human Plasma||0.500 to 500 ng/mL||K2EDTA|
|N-Desmethyl Sildenafil||Human Plasma||0.500 to 500 ng/mL||K2EDTA|
|Tacrolimus||Whole Blood||0.100 to 100 ng/mL||K2EDTA|
|Telmisartan||Human Plasma||0.500 to 5000 ng/mL||K3EDTA|
|Valproic Acid||Human Serum||1.00 to 100 pg/mL||N/A|
|R-and S-Warfarin (Chiral)||Human Plasma||10.0 to 2500 ng/mL||K2EDTA|
|Dextromethorphan||Human Plasma||10.0 to 5,000 pg/mL||K2EDTA|
|Fluconazole||Human Plasma||20.0 to 10,000 ng/mL||K2EDTA|
|Rifampin||Human Plasma||0.100 to 10.0 pg/mL||K2EDTA|
|Rosuvastatin||Human Plasma||0.100 to 100 ng/mL||K2EDTA|
Our in-house Quality Assurance department oversees the integrity of all the data we generate and the reports we publish. Pyxant Labs' QA team is set up to simulate an on-site FDA audit team, ensuring we adhere to the latest guidance. GLP studies are run against a set of standard operating procedures by staff who have received extensive training on all aspects of the study.
Additionally, our Quality Assurance Manager is a member of the GLP section and a co-chair of the Bioanalytical Specialty section for the Society of Quality Assurance and is a member of the Rocky Mountain Regional Chapter of the Society of Quality Assurance. Moreover, our Laboratory Direct has been a member of the Global CRO Council (GCC) since its inception.
Besides regular internal audits, Pyxant Labs always welcomes audits and site inspections from existing and potential clients. We have had multiple inspections to date by the FDA (CDER, CVM), which resulted in no findings impacting data quality.
We have a dedicated technical team assigned to reporting and offering customized reports on a project-by-project basis.
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