Bioanalytical Testing Services
Navigating regulatory requirements for bioanalytical testing can be challenging and time-consuming. Absorption Systems’ bioanalytical experts will provide you with complete study support, from custom method development through validation and sample analysis.
Quantitative measurements of analytes such as drugs and their metabolites are “critical for the successful conduct of nonclinical, biopharmaceutics, and clinical pharmacology studies.” (Bioanalytical Method Validation Guidance for Industry, FDA, May 2018).
Our bioanalytical testing services provide state-of-the-art quantifications of analytes. We have experience with a range of active drug types, from small molecules to peptides, and their metabolites. We can perform analyses in complex biological matrices including plasma, serum, urine, feces, bile, and tissue.
Our approach puts clients’ needs first. We offer Research Use Only (RUO) studies, as well as GMP, GcLP, and GLP method development, validation, and sample analysis, with the rigor required to satisfy regulatory agencies. We routinely provide bioanalysis for compound screening, preclinical pharmacokinetic (PK), toxicokinetic (TK) studies, biomarker and cytokine analysis, and GLP sample analysis for human clinical trials.
In addition, we specialize in supporting bioanalysis of cell and gene therapy products. Specialist bioanalytical assays for these include biodistribution, shedding analysis, NAb and ADA testing, as well as cellular immunogenicity. To find out more about this, why not read our white paper on Nab assays for gene therapies. We also offer radioactive drug detection services.
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The Absorption Systems Difference Absorption Systems offer a single source of reliable data for all of your bioanalytical testing needs. Our labs support detection of compounds at all stages of development, from drug discovery, to nonclinical and clinical studies. All our bioanalytical projects, from the simplest sample management and analysis to the most complex method validation, are approached with a focus on accuracy, precision, efficiency, and speed. We’re here to enable you to make informed decisions quickly and confidently. |
FREQUENTLY ASKED QUESTIONS
What type of bioanalytical services do you offer for small molecule testing?
Absorption Systems offers in-house bioanalytical support for all in vitro and in vivo studies.
- Custom, proprietary method development specific to the stage of development.
- Collection, stabilization, and extraction techniques optimized for each molecule and matrix.
- Bioanalytical expertise to support chiral compounds, endogenous compounds, and metabolites.
What types of bioanalytical methods for small molecule testing does Absorption Systems support?
Our small molecule bioanalytical methods include:
- In vitro bioequivalence
- Solubility, GI stability, release and permeation for ANDA submission
- IND-enabling PK, toxicology, and biomarker analysis
- Circulating concentrations or presence/activity at target tissues
- Preclinical ocular biodistribution
- We are experts in dissection, extraction, and sensitivity requirements
- Clinical bioanalysis
- Support throughout all phases of drug development, from discovery to the clinic
What type of bioanalytical testing services do you offer for cell and gene therapy?
With multiple platforms, we can support quantitation of the product and the biomarkers or enzymes that represent the product’s mechanism of action.
- Relative potency assays combine cell biology with LC-MS/MS or ELISA detection
- LC-MS/MS or HRAMS analysis for impurities and post-translational modifications
- Our GMP certificate is issued by EU to support global submissions
Technologies and Methodologies
State-of-the-art mass spectrometry for bioanalytics
Our labs are equipped with LC-MS/MS systems, allowing for the analysis of thousands of samples a day. LC-MS/MS data is generated using Analyst® Version 1.6.3 compliant with 21 CFR Part 11, and all customer reports are archived in a validated eQCM by Xybion database compliant with 21 CFR Part 11.
Additional technologies:
- AB Sciex 4000 QTRAP
- AB Sciex API 4000
- Conventional HPLC with UV detection
- Fluorescence detectors
- Leap CTC Analytics Autosamplers
- Scintillation counters
- Thermo Scientific LTQ Orbitrap XL
- Tomtec Quadra 96 robotic sample prep workstation
- Waters Acquity UPLC
- Xevo TQ-S UPLC-MS/MS
Cell and gene therapy instrumentation:
- Roche LightCycler® 480 qPCR System
- QX200 Droplet Digital PCR (ddPCR™) system
- QIAGEN QIAcube for DNA/RNA purification
- Qubit® Fluorometer for RNA concentration
- BMG CLARIOstar® for DNA concentration (A260/A280 ratio)
REGULATORY CONSIDERATIONS
Certified facilities
Our facilities are FDA-audited and EMA inspected, and we comply with 21 CFR Part 11 and Part 58.
Cutting-edge standard operating procedures (SOPs)
We use SOP-driven validations and analysis based on current FDA and EMA guidance. Validation of bioanalytical methods follows the May 2018 U.S. Food and Drug Administration (FDA) “Guidance for Industry: Bioanalytical Method Validation” and the Absorption Systems Standard Operating Procedure (SOP) “Validation of Quantitative Bioanalytical Methods for Determination of Test Compounds and/or Their Metabolites in Biological Matrices.”
GLP bioanalysis also follows the FDA Good Laboratory Practices (GLP) regulations (21 CFR Part 58) and the OECD Principles of Good Laboratory Practice. In addition, all studies follow our own relevant SOPs.
RELATED SERVICES
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Molecular Biology Testing
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Biomarker and Cytokine Analysis
