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COVID-19 Update: 08MAY2020

Colorado has issued a statewide safer-at-home health order, whereby Pyxant Labs will remain open as a critical healthcare operation. In accordance with the CDC's Interim Guidance for Businesses and Employers, Pyxant Labs is monitoring the spread of COVID-19, while providing continued service during this global emergency. We are committed to supporting our clients' efforts to combat COVID-19 and help restore health around the world.
  • Pyxant Labs is a high-end customer-centric bioanalytical contract research organization. At any stage in your program, our commitment is to provide you with quick, accurate results. We are confident your data will withstand any regulatory scrutiny and help you make those crucial program decisions.
  • Pyxant Labs is a high-end customer-centric bioanalytical contract research organization. At any stage in your program, our commitment is to provide you with quick, accurate results. We are confident your data will withstand any regulatory scrutiny and help you make those crucial program decisions.
  • Pyxant Labs is a high-end customer-centric bioanalytical contract research organization. At any stage in your program, our commitment is to provide you with quick, accurate results. We are confident your data will withstand any regulatory scrutiny and help you make those crucial program decisions.
  • Pyxant Labs is a high-end customer-centric bioanalytical contract research organization. At any stage in your program, our commitment is to provide you with quick, accurate results. We are confident your data will withstand any regulatory scrutiny and help you make those crucial program decisions.
  • Pyxant Labs is a high-end customer-centric bioanalytical contract research organization. At any stage in your program, our commitment is to provide you with quick, accurate results. We are confident your data will withstand any regulatory scrutiny and help you make those crucial program decisions.
  • Pyxant Labs is a high-end customer-centric bioanalytical contract research organization. At any stage in your program, our commitment is to provide you with quick, accurate results. We are confident your data will withstand any regulatory scrutiny and help you make those crucial program decisions.

Services

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.
 
 

Fast Turnaround Discovery

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.

Method Development & Validation

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.

Sample Analysis

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.

FDA Center for Veterinary Medicine Support

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.

High-Resolution Mass Spectrometry

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.

Oligonucleotide Testing

In addition to our years of experience with LC/MS/MS, Pyxant Labs offers support for oligonucleotide testing using high-resolution mass spectrometry (HRMS), hybridization-based LC-fluorescence, hybridization ELISA, or branched DNA techniques, which we are implementing at Pyxant Labs.

Tissue Bioanalysis

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.

Non-Proprietary Assays

Please, contact us if your compound is not on this list.
 

Non-proprietary Assay
 
Matrix
 
Method Range
 
Anticoagulant
 
Atazanavir Human Plasma 10 to 10,000 ng/mL K2EDTA
ATRIPLA™ (Tenofovir, Emtricitabine, Efavirenz) Human Plasma 5 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 ng/mL K2EDTA
Clindamycin Human Plasma 50 to 50,000 ng/mL K2EDTA
Cyclosporine Whole Blood 2.00 to 2000 ng/mL K2EDTA
Darunavir Human Plasma 10 to 10,000 ng/mL K2EDTA
Dextromethorphan Human Plasma 1 to 500 ng/mL K2EDTA
Dextromethorphan Human Urine 1 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 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 5.0 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 to 100 pg/mL N/A
R-and S-Warfarin (Chiral) Human Plasma 10.0 to 2500 ng/mL K2EDTA
 
In Development
 
Dextromethorphan Human Plasma 10 to 5,000 pg/mL K2EDTA
Fluconazole Human Plasma 20 to 10,000 ng/mL K2EDTA
Rifampin Human Plasma 0.1 to 10 pg/mL K2EDTA
Rosuvastatin Human Plasma 0.10 to 100 ng/mL K2EDTA

Quality & Compliance


Quality Assurance & Reporting

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.

Customer Service Team

 
You will often find our customer service team members at conferences or at meetings, exchanging knowledge and networking with those in the industry. If you happen to be at the same event, feel free to reach out to us for a meeting, or stop by our table if we’re exhibiting.
Customer Service Team

Adam Winstrom

Director, Client Management

Olivia Franks

Client Manager

David Brodie

Client Manager

John Begley

Senior Program Manager

Jeremy Thompson

Senior Program Manager

Cassidy Hatch

Associate Program Manager

Kylie Smith

Study Coordinator

Karla Irizarry-López

Study Coordinator

Michael Olson

Director of Business Development

Careers

Pyxant Labs is a dynamic company encompassing a growing bioanalytical contract research organization and a high-end reference laboratory subsidiary. Our core focus is on customer service, as well as regulatory and technical expertise, structured to create industry leading customer satisfaction.

We recognize experienced and highly qualified team players are essential to the success of our company. The only way to deliver on our objectives is to recruit, develop, and retain exceptional people. Our human resources management practices, including training, role design, project assignments, and infrastructure, contribute to a successful employee experience.

Current Positions

Pyxant CRO analyzing vials

Contact Us

We are located in Colorado Springs, CO conveniently close to downtown and I-25.

From I-25, head west on Garden of the Gods Road, turn right on Forge Road, then turn left at 4720 Forge Road, Suite 106, Colorado Springs, CO 80907.

Our staff is always available for questions. Call us during business hours, or e-mail us anytime.

Phone: +1 (719) 593-1165
Fax: +1 (719) 593-1625
E-mail: info@pyxant.com