Bioanalysis (Nonclinical and Clinical)
Our global bioanalytical laboratories use a wide range of techniques and technology platforms to meet the needs of our customers. With 15 facilities worldwide our experience spans chromatography, mass spectrometry, immunochemistry, cell-based assays, flow cytometry, molecular biology, and more in support of PK/TK, pharmacology, bioequivalence and bioavailability studies, and biomarker assays from early discovery to post marketing. Bioanalysis is somewhat unique in that it is required for the evaluation of a therapeutic throughout the entire drug development cycle.
From start to finish our scientists are universally connected and can support your complex challenges through a bioanalytical network of experts, provide rapid lead-in times, and help you select the most reliable analytical methodology with quality standard operating procedures (SOPs) in order to meet critical deadlines. We understand the focus changes from the early discovery scientific stages of lead selection/ optimization and nonclinical development where developing and refining methods in a variety of species and biological matrices is critical to the later clinical stage challenges of sample collection, logistics and handling along with the significant data management needs.
Bioanalytical method development is a common hiccup in safety assessment. Learn More
We routinely develop or transfer, optimize, validate and apply quantitative bioanalytical methods to measure drug and metabolite concentrations for samples in most any biological fluid including both standard plasma, serum, cerebrospinal fluid (CSF), urine, and tissue and unconventional matrices like ocular, muscle, and bile. Optimizing existing methods to increase efficiency and robustness, identify liabilities, and de-risk regulated issues is a constant priority. New methods and new technologies are continually developed and validated to meet the ever-changing and increasing demand of our clients and for the innovative drugs coming through their pipelines.
Our non-regulated research grade assays and regulated bioanalytical services can be performed on small and large molecules, including antibody-drug conjugates, biosimilars, monoclonal antibodies, oligonucleotides, peptides, proteins, and vaccines. Our SOPs confirm compliance with Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (cGLP), and current regulatory bioanalytical guidance documents issued by the relevant regulatory bodies.
Our scientific and regulatory staff are familiar with the current validation guidances – are you?
Available Bioanalytical Services
- Method Development and Transfer
- Non-GLP and Discovery Bioanalysis
- GLP Chromatographic and Mass Spectrometric Bioanalysis
- GLP Ligand Binding Assay Bioanalysis
Bioanalytical Services Frequently Asked Questions (FAQs)
What is bioanalytical chemistry?
Quantitative determination of drugs and/or metabolites in biological matrices such as blood, serum, plasma, or urine, tissue and skin samples specifically applied to toxicology, pharmacology, bioequivalence, pharmacokinetic, and bioavailability studies in animals or humans.
What is a bioanalytical method validation?
A bioanalytical validation proves that the optimized method developed is acceptable for the analysis of biological study samples and evaluates accuracy, precision, recovery and stability.
What is incurred sample reanalysis (ISR)?
ISR demonstrates bioanalytical assay reproducibility using incurred (study) samples. It is important for both preclinical and clinical study samples as incurred samples can differ significantly in composition as compared to the calibration standards and quality controls used to validate a method.
What is LLOD, LLOQ, and ULOQ?
Lower limit of detection (LLOD) is the lowest quantity or concentration of an analyte that can be detected with an analytical method. Lower limit of quantification (LLOQ) is the lowest amount of an analyte in a sample that can be quantitatively determined with predefined precision and accuracy and designated as the lowest standard on the calibration curve. Upper limit of quantitation (ULOQ) The upper limit of quantification is the highest amount of an analyte in a sample that can be quantitatively determined with predefined precision and accuracy.