Bioanalytical Solutions

Have a Question?

Delivering Excellence in Bioanalytical Services

Because your satisfaction is our top priority, we’ll assign you a single point of contact whose job it is to communicate on a timely basis and make sure your requirements are met throughout the entire life of your project. To support this, all of our teams that carry out bioanalysis comply with the current standards for Good Clinical Practices (GCP) and Good Laboratory Practices (GLP). 

 

Click here to view our validated Bioanalytical Assay List

  • 2 GLP-compliant bioanalysis laboratories with robotics and LIMS to provide you with consistent, accurate data 
  • 17 audits from regulatory agencies (including FDA, EMA, HC, ANVISA) in past 5 years
  • 22+ years of operations
  • 24 hours per day, 7 days per week operation 
  • 95%+ ISR performance 
  • 300 dedicated bioanalytical professionals 
  • 500+ projects completed annually 
  • >80,000 biologics/biomarkers samples analyzed annually
  • >800,000+ regulated and non-GLP samples analyzed annually

 

We Honor Our Commitments

Our bioanalytical services center around delivering on our commitment to meet project schedules without compromising quality and compliance. Because we recognize your need for fast turnaround, method development and proof-of-concept can typically be performed within a few days, enabling quick go/no-go decisions.

 

We're a CRO With a Large and Diverse Capacity

We take the “full capability” approach to bioanalytical services, regardless of your project size. Through our GLP-compliant laboratories, an extensive list of validated assays, custom assay services, knowledgeable scientists and skilled technicians, we provide bioanalytical services at all stages of drug development.

Then, we combine our significant experience with small and large molecules, peptides, immunochemistry, LC/MS/MS, HRMS, GC/MS/MS, ICP-MS and blend innovative science with efficient, validated processes.

 

In-House Expertise and Modern Instrumentation for Rapid Turnaround Times

We have a long history of partnering with biopharmaceutical companies for in vivo, non-regulated preclinical bioanalysis of plasma and tissue samples. We have in-house expertise and access to a sophisticated array of modern instrumentation that enables rapid turnaround times.

Customers look to us to develop bioanalytical methods and assay samples generated in a non-GLP, high-throughput environment and to report sample concentrations with preliminary pharmacokinetics (PK) using WinNonlin® or Watson LIMS.

We offer HRMS-based methods, as well as traditional multiple reaction monitoring (MRM) assays using ultra-performance liquid-chromatography (UPLC) triple quadrupole LC/MS/MS analysis for PK work. We also offer specialized expertise in tissue analysis to support drug distribution studies, proteins, peptides, ADCs and nucleotides.

Our process is standardized around a robotics platform, which allows for improved precision, better reproducibility and fewer errors. We offer protein binding, bioavailability, early toxicology and method qualification services for the target compound, as well as its metabolites.

 

Method Development and Validation

We offer custom method development, assay validation and sample analysis using state-of-the-art LC/MS/MS and immunochemistry assays and a team of detail-oriented scientists. Our staff has developed LC/MS/MS methods including routinely quantifying levels below one pg/mL.

We have methods for multiple analytes, metabolites, prodrugs and light- and temperature-sensitive compounds. Standard timelines for validation is around 5–10 days.

 

Ligand Binding

We provide a growing menu of standard and custom assays optimized for the quantitation of multiple analytes (proteins) in serum, EDTA and heparin, as well as sodium citrate plasma, culture supernatant and other sample types.

Our immunoassay capabilities include single analytes and multiplexing. Services include development, optimization and validation of proprietary assays, transfer and validation of existing assays and validation of commercially available kits.

Significant experience in the development and validation of immunoassays for large molecules and biomarkers gives our clinical scientists special insight into the development of bioanalytical technologies. Work performed in our GLP-compliant immunochemistry facilities includes proprietary and non-proprietary pharmacokinetic and immunogenicity assays, as well as a wide range of cell-based and enzymatic assays.

By rapidly providing specialized immunogenicity testing for the presence of antibodies to biologic and biosimilar products, we can help move your large molecule development programs forward quickly and smoothly.

Our bioanalytical technologies and experience allows applications of a variety of immunoassay platforms, including: electrochemiluminescence (ECL), ELISA, fluorescence, luminescence and radioimmunoassays.

 

Quantitative Biomarkers

We provide mass spectrometry-based and immunochemical analyses for the development, validation and measurement of biomarkers, including targeted and non-targeted biochemical and protein profiling. Our methods ensure precise, accurate measurement of biomarkers for therapeutic disease endpoints for infectious and autoimmune diseases, cardiovascular risk, and blood components including hormones, cytokines, chemokines and acute-phase reactants.

 

ICP-MS

We offer ICP-MS to support (but not limited to) oncology trials. In the past decade, the advances in oncology medication, pain relief, chemotherapy or other therapy has dramatically changed the way cancer is diagnosed and treated.

Carboplatin and cisplatin are chemotherapy medications used to treat a number of forms of cancer. These compounds contain the element platinum that can be analyzed using the inductively-coupled plasma mass spectrometry or ICP-MS. 

This instrument is designed for the analysis of natural elements such as platinum, iron, sodium, lithium and potassium. The diluted sample extracts are introduced in an argon plasma torch to be nebulized and ions are directed towards the quadrupole filer of the mass spectrometry detector by a set of lenses.

We have extended our expertise throughout the years and have validated several assays for the analysis of elements such as platinum, iron, sodium, potassium, zinc, lithium, strontium and bismuth. We have recently developed a combo assay for the measurement of magnesium, calcium and phosphorus in human serum and urine.

These methods are validated as per the most recent regulatory guidelines for bioanalytical method validations. Most of them were used successfully for study sample analyses. Other areas of interest include biomarkers (Na, K, Mg, Ca, Fe, PO4) and metal-based drugs (Li, K, SR, Bi, Zn, Pt).

 

Ensuring the Best Quality and Highest Consistency of Critical Reagents

Successful Ligand Binding Assays (LBAs) are dependent on the use of quality critical reagents. Lot-to-lot inconsistencies can cause changes in assay reproducibility, robustness and accuracy. By ensuring uniformity throughout the life cycle of a critical reagent’s use, we can effectively eliminate the need for tedious and costly assay bridging and, perhaps, revalidation.

By employing Preparative SEC, Analytical SEC, High Resolution Mass Spectrometry and Tangential Flow Filtration, our lab has established a rigorous and flexible method by which aggregation, purity and incorporation ratio (label:protein) can all be accurately quantitated and reported during the production and life cycle of the reagent.