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. 

The Absorption Systems Difference

We offer a full range of bioanalytical testing services supporting drug discovery and all clinical phases to pinpoint the detection of your compound. All 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.

Our bioanalytical testing services provide quantitative measurements on a range of active drugs, from small molecules to peptides, as well as metabolites. We can perform analysis in complex biological matrices such as plasma, serum, urine, feces, bile, and tissue.

We offer Research Use Only (RUO), 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.

We specialize in supporting cell and gene therapy studies including biodistribution, shedding analysis, NAb and ADA testing, as well as cellular immunogenicity. We also offer radioactive drug detection. 

With our robust analytical methods, you can depend on a single lab for reliable data in all of your nonclinical and clinical studies, enabling you to make informed decisions at all stage s of development 

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

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 include: 

  • 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

Our cell and gene therapy instrumentation includes:

  • 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

We use SOP-driven validations and analysis based on current FDA and EMA guidance. Our facilities are FDA-audited and EMA inspected, and we comply with 21 CFR Part 11 and Part 58.

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.

Regulatory Considerations for Lot Release Potency Assays

  • ICH Guidance for Industry – Q2B Validation of Analytical Procedures: Methodology
  • Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products
  • USP <1032> Design and Development of Biological Assays
  • USP <1033> Biological Assay Validation
  • USP <1034> Analysis of Biological Assays

Regulatory Considerations for PCR Assays for Biodistribution

  • Guidance for Industry: Gene Therapy Clinical Trials – Observing Subjects for Delayed Adverse Events
  • Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products
  • The MIQE Guidelines: Minimum Information for Publication of Quantitative Real-Time PCR Experiments

RELATED SERVICES

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Molecular Biology Testing

Immunogenicity Testing

Biomarker and Cytokine Analysis

Cell-Based Assays

WHAT TYPE OF BIOANALYSIS DO YOU NEED PERFORMED?