Bioanalytical Testing Services: Ensuring Drug Safety and Efficacy FDA's Role in Protecting Public Health
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| Bioanalytical Testing Services |
Bioanalytical
testing refers to analytical methods and techniques that are used to
quantitatively measure drugs, metabolites, biomarkers, or biomarkers of
exposure in biological matrices like plasma, serum, urine, or tissue
homogenates. These techniques play a vital role in drug development and are
crucial for evaluating pharmacokinetic studies and clinical trial results.
Bioanalytical testing is required at various stages of drug development
including pre-clinical, clinical, and post-marketing.
Regulatory Requirements for
Bioanalytical Methods
Regulatory agencies like the FDA and EMA have stringent guidelines and criteria
for method validation of bioanalytical techniques used in quantifying drugs and
metabolites in biological matrices. Key validation characteristics that must be
demonstrated include specificity, selectivity, precision, accuracy,
reproducibility, calibration curve, lower limit of quantification, dilution
integrity, benchtop stability, freeze-thaw stability etc. Validation results
must be documented in a bioanalytical method report and be made available for
regulatory review if requested. Any changes made to a validated bioanalytical
method also require re-validation.
Sample Preparation Techniques
Proper sample preparation is crucial for Bioanalytical
Testing as it ensures efficient extraction of analytes from biological
matrices prior to analysis. Common sample preparation techniques include
protein precipitation, liquid-liquid extraction, solid phase extraction etc.
Technique chosen depends on analyte properties, matrix type,
selectivity/sensitivity needs. Sample preparation must effectively extract
analytes while removing potential interfering matrix components. Automated
liquid handling workstations are commonly used to streamline high throughput sample
preparation for clinical studies.
Instrumental Techniques for Analysis
Following are some key instrumental techniques used for quantifying
drugs/metabolites in bioanalytical testing:
Liquid Chromatography-Mass Spectrometry (LC-MS/MS): Considered the gold
standard technique due to its high selectivity and sensitivity. LC separation
coupled with MS/MS detection enables reliable quantification of analytes even
at low pg/mL levels in complex matrices. LC-MS/MS bioanalytical methods have
largely replaced immunoassays.
Liquid Chromatography with UV detection (LC-UV): Used for analytes that do not
require extremely high sensitivity. UV detectors are simple and robust but lack
the selectivity of mass spectrometry.
Immunoassays: Techniques like ELISA, RIA were previously commonly used but have
been replaced by LC-MS/MS for most applications due to superior performance.
Immunoassays still find some use in specific scenarios.
Other techniques like gas chromatography-mass spectrometry (GC-MS) are also
used but to a lesser extent than LC-MS/MS. Selection of appropriate technique
depends on analyte properties and method performance requirements.
Method Validation and Reporting
As per regulatory guidelines, validation of a new bioanalytical method must be
performed to demonstrate it is reliable, reproducible and fit-for-purpose prior
to sample analysis. Key validation characteristics evaluated include:
- Selectivity: Assess for interference from blank matrix and ensure analyte can
be reliably quantified.
- Calibration curve: Establish linear response over concentration range and
ensure back-calculated standards meet accuracy criteria.
- Accuracy and precision: Determine inter- and intra-assay accuracy and
precision using quality control samples.
- Lower limit of quantification: Establish lowest concentration level that
meets precision and accuracy criteria.
- Recovery: Assess extraction efficiency of analyte from matrix.
- Stability: Evaluate stability of analyte under various conditions like
freeze-thaw, bench-top, stock solution etc.
Detailed validation results and documentation as per regulatory format is
essential. Any subsequent changes to method also necessitate re-validation.
Well validated bioanalytical methods are critical to ensuring reliability of
clinical trial data.
Bioanalytical Testing Services
Due to complex nature of analyses and stringent regulatory needs, most
pharmaceutical/biotech companies outsource bioanalytical work to specialized
contract research organizations (CROs) providing bioanalytical testing
services. Key services provided by such CROs include:
- Development and validation of new bioanalytical methods for drugs/metabolites
across various matrices.
- Sample analysis using validated methods to support pharmacokinetic, bioavailability,
bioequivalence and clinical studies.
- Detailed method validation report preparation adhering to FDA/EMA guidance.
- Incurred sample reanalysis to confirm reproducibility of analytical runs.
- Stability indicating method development for analytes prone to instability.
- Qualified analysts, state-of-art instrumentation and optimized automated
sample preparation workflows for high throughput analyses.
- Expert data review, integration and reporting to sponsors as per study needs.
- Analytical support for late phase clinical trials, generic applications and
routine therapeutic monitoring.
Leading bioanalytical CROs have extensive experience, industry recognized
certifications like GLP and adhere to global quality standards to help clients
meet regulatory standards through reliable, timely bioanalysis outsourcing
services. This enables sponsors to focus core competencies while ensuring
quality bioanalytical data generation.
In
conclusion, well developed and validated bioanalytical methods coupled with
high quality sample analysis services provide a foundation for evidence
generation from pharmacokinetic and clinical studies. By selecting reputed CROs
with demonstrated expertise in developing robust assays, method validation and
data reporting as per regulatory standards, biopharma companies can be assured
of quality analytical support enabling on-time product development timelines.
Outsourced bioanalysis services thus serve as a reliable, efficient alternative
to in-house capabilities especially for smaller to mid-size firms.
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About Author:
Ravina
Pandya, Content
Writer, has a strong foothold in the market research industry. She specializes
in writing well-researched articles from different industries, including food and
beverages, information and technology, healthcare, chemical and materials, etc.
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