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| Bioanalytical Testing Services |
With the breakthroughs achieved in fields of biotechnology, drug discovery has
progressed vastly in the past few decades. New biological entities and
therapies being developed require rigorous testing to ensure their safety as
well as efficacy for patients. This is where bioanalytical testing services
play a pivotal role in drug development process.
What are Bioanalytical Testing Services?
Bioanalytical testing refers to quantitative and qualitative evaluation of
biological samples like blood, plasma, serum, urine etc. to determine the
presence, concentration and properties of therapeutic agents, their metabolites
as well as biomarkers. Laboratories providing such testing services have capabilities
to analyze drug candidates using analytical techniques like liquid
chromatography coupled with mass spectrometry (LC-MS).
Bioanalytical
Testing Services aid pharmaceutical and biotech companies in
preclinical, clinical as well as post marketing stages of drug development by
providing crucial pharmacokinetic and toxicokinetic data. The data obtained
from bioanalytical methods helps in understanding absorption, distribution,
metabolism and excretion (ADME) properties of novel molecules which further
guides clinical dosage selection and design.
Why are Bioanalytical Services Important?
With growing complexity of disease conditions and biotherapeutics, importance
of robust bioanalytical testing has increased manifold. Some key reasons
highlighting its necessity are:
- Safety evaluation: It enables quantification of drugs and metabolites in
biological samples which provides insights about toxicity, side effects and
drug-drug interactions. This helps assess safety risk profile of a candidate in
early stages itself.
- Pharmacokinetic studies: Through quantitative estimation of parent drug and
metabolites in blood/tissue over time, it facilitates pharmacokinetic
assessment which is vital for dosage optimization and selection.
- Biomarker analysis: Biomarkers related to disease pathogenesis and drug
responses can be evaluated to demonstrate mode of action and efficacy of drug
candidates during development.
- Method development and validation: It involves developing and validating
sensitive, specific and reproducible bioanalytical methods for target molecules
which is a regulatory requirement.
- Bioequivalence/bioavailability testing: These tests are carried out to
evaluate therapeutic equivalence of generic drugs, different dosage forms using
bioanalytical methods.
Major Techniques Used in Bioanalysis
The most commonly applied technologies in modern bioanalytical laboratories
are:
Liquid Chromatography-Mass Spectrometry (LC-MS/MS): It has become the gold
standard technique due to high sensitivity, selectivity and ability to analyze
complex matrices. LC is coupled with tandem quadrupole or ion trap MS for
quantification of analytes and metabolites.
Liquid Chromatography (LC): Used for assays where MS detection is not required.
HPLC is preferred for separation of polar/ionic analytes while UPLC provides
faster run times.
Gas Chromatography-Mass Spectrometry (GC-MS): Applicable for analyzing
volatile, thermally-stable compounds and their metabolic byproducts from in
vivo or in vitro studies.
Immunoassays: Techniques like ELISA, RIA are used for large molecule
drugs/biologics analysis wherever cross-reactivity and specificity is the major
concern.
Surface Plasmon Resonance (SPR): Used to study biomolecular interactions in
drug discovery and development programs.
Services Offered by Leading Bioanalytical Testing Facilities
Bioanalytical method development and validation: It involves protocol
optimization, selectivity, accuracy, precision, calibration model, dilution
integrity etc.
Pharmacokinetic studies: Involves sample analysis from PK and toxicokinetic
studies to determine parameters like Cmax, Tmax, AUC, t1/2 in animals and
humans.
Bioavailability/bioequivalence assessment: Evaluates rate and extent of drug
absorption from different formulations through BA/BE tests.
Immunogenicity testing: Detect and quantify anti-drug antibodies developed
against biological drugs which can impact efficacy.
Biomarker analysis: Quantification of endogenous/exogenous biomolecules through
disease and treatment response monitoring.
Stability indicating assays: Standard methods for analysis of stress degraded
samples as per ICH guidelines.
Dedicated project management: For planning, executing and reporting
preclinical/clinical PK/PD/TK study results on schedule.
Bioanalytical testing plays a critical role in drug development by providing
quantitative data to evaluate pharmacokinetic and pharmacodynamics properties
thereby deciding success or failure of candidates in early stages itself.
Choosing a GLP compliant, sensitive and experienced CRO is highly recommended
by sponsors for obtaining reliable bioanalytical results.
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