Bioanalytical testing involves the quantitative evaluation of drugs/xenobiotics and their metabolites present in biological samples such as blood, serum, urine, and tissue samples. It uses analytical chemistry techniques to detect small or large molecules present.
Bioanalytical data is essential to preclinical and clinical trials, including pharmacokinetics (PK), toxicokinetics, and bioequivalence studies, to develop therapeutics. Without it, therapeutics could never come into being.
Spinos Bioanalytical Service Company, Coimbatore takes pride in leading the field of bioanalytical testing. Our commitment to precision and innovation ensures accurate quantification of drugs and metabolites in biological samples. Utilizing cutting-edge techniques, we provide reliable insights crucial for drug development at every stage, setting the standard for excellence in bioanalytical services.
1. Accuracy
An analytical method can be considered accurate when its test results reflect the concentration of an analyte within its detection limits, providing accurate readings down to its LLOQ (low concentration limit of quantification).
As bioanalytical applications rely on precise measurements, an assay must measure target molecules with high precision and accuracy. Due to biomolecules’ complexity and sensitivity to changes in pH, temperature, or ionic strength that disrupt molecular interactions. As such, special techniques have been created such as liquid chromatography and mass spectrometry that isolate and analyze biological samples efficiently.
As part of an analytical assay’s accuracy evaluation, a calibration curve must be constructed. This curve consists of six to eight non-zero samples prepared at different concentrations that serve as blank and zero samples respectively. When applied with assay results compared with predicted values using the linear fit method; any difference between them and actual values determines its precision.
Precision for bioanalytical assays is measured by comparing measurements made on multiple replicate samples from one batch; this is known as between-run precision or repeatability and represents a measure of consistency within measurements; taking into account factors like analyte stability, assay conditions and sample collection/handling procedures, this measure should not deviate more than 20% from its mean value.
2. Specificity
Selectivity refers to a method’s ability to discriminate and quantify drugs or their metabolites from other components in a sample and is an essential characteristic of bioanalytical methods for accurate evaluation of clinically important parameters like pharmacokinetics, toxicokinetics, and bioavailability/bioequivalence.
Bioanalytical method development entails creating an accurate and precise method for the determination of target analytes in biological samples, using techniques such as liquid chromatography-mass spectrometry (LCMSMS), electrophoresis, immunoassays, and others. Liquid chromatography-mass spectrometry is often utilized as it combines physical separation techniques (liquid chromatography) with mass analysis technologies (mass spectrometry). Furthermore, multiplexing allows it to detect multiple compounds present simultaneously in one sample by multiplexing.
To determine the accuracy of a bioanalytical method, it must be evaluated against a set of acceptance criteria. These should include a limit of detection, lower limit of quantitation, linearity, and reproducibility as well as the capability of detecting interference from exogenous substances such as endogenous matrix components or metabolites.
To assess these criteria, the method should be evaluated against a reference standard. This can be accomplished by creating calibration standards or quality control (QC) samples; quality control samples may involve diluting a reference standard in biological matrix samples or by adding analytes directly. Results from such tests may then be used to generate calibration curves and assess method performance against acceptable tolerance limits specified by regulatory authorities.
3. Efficiency
Bioanalytical studies rely on accurate, precise, and repeatable analytical methods that produce results that are precise, precise, and repeatable – an especially crucial aspect as bioanalytical analyses may serve as the linchpin in drug approval processes; without accurate and reproducible analysis results, development processes would likely slow or stop altogether.
Bioanalytical methods are designed to assess analytes in biological samples such as tissues, blood samples, and body fluids for analytical analyses that help characterize new chemical entities (NCEs) during nonclinical, preclinical, and clinical pharmacology studies that support applications for drug approval. These tests play an integral part in providing critical pharmacokinetic/pharmacodynamic information.
Sensitivity and accuracy in bioanalytical methods depend on their use of an adequate biological matrix as well as on the analytical technique employed. For instance, LC-MS/MS with electrospray ionization and multiple or selected reaction monitoring has become the standard approach in bioanalytical research for its high sensitivity (nanomolar or picomolar levels), but requires well-characterized reference standards diluted in organic solvent and then spiked directly into biological matrix samples for accuracy.
However, unlike standard analytical tests which can be conducted independently in-house, bioanalytical methods must be created and validated according to regulatory requirements – a potentially time-consuming and expensive endeavor.
Partnership with a Clinical Laboratory Service is often the optimal approach when developing bioanalytical methods. Such laboratories can offer a comprehensive array of services and have access to numerous instruments; additionally, they possess expertise gained through testing numerous assays over time which can save both time and effort in formulating bioanalytical methods.
4. Flexibility
Bioanalytical methods play a pivotal role in nonclinical and clinical pharmacology testing, providing vital data that supports drug development. Unfortunately, developing these methods is time-consuming and resource-intensive; furthermore ensuring they comply with all relevant FDA or other regulatory requirements is also vital to conducting safe toxicology studies and ultimately bringing new medicines to market.
Development of a bioanalytical method requires careful consideration to ensure all steps comply with Good Laboratory Practice (GLP) regulations and are performed to a high standard. Furthermore, the method must adhere to a minimum quality standard while being robust enough and reliable enough to produce concentration data; finally, it must allow for the analysis of analytes in different biological matrices and conditions of tests.
Liquid chromatography-tandem mass spectrometry (LC-MS-MS) and enzyme-linked immunosorbent assays (ELISA) are widely employed techniques for quantifying small molecules and macromolecules respectively, offering high sensitivity and resolution but aren’t suitable for every application; accordingly, it’s essential to select an appropriate system and optimize LC-MS-MS parameters according to sample type/matrices to prevent issues arising during quantification.
Bioanalytical methods tend to involve an intricate series of substeps that make automation challenging. Therefore, all required subprocesses and their parameters and boundaries must be identified and analyzed to select an ideal automation concept.
Screening methods involve only a few process steps and typically use microtiter plate formats as they can easily be integrated with other screening tests on one automation system. Thanks to flexible technology (e.g., liquid handler) being utilized by this testing methodology – such as dual-arm robots or manual devices such as pipettes or syringes being implemented – screening methods can easily be combined on an automated system and integrated seamlessly.
5. Cost
Bioanalytical testing is vital to ensure successful drug development. It plays a pivotal role in every stage of drug discovery – from preclinical and clinical DMPK studies through to pharmacokinetic (PK) analyses and toxicology assessments. Without accurate, robust, and timely bioanalytical data, an innovative new medicine may miss key milestones and ultimately fail in the marketplace.
Development and execution of bioanalytical assays for nonclinical and early clinical research studies can be prohibitively expensive, choosing an experienced CRO with expertise in bioanalytical assay development as well as interaction with regulatory authorities is a wise investment in time and resources.
Bioanalytical methods’ ability to detect small molecules, peptides, proteins, nucleic acids, and metabolites from very small samples is invaluable when it comes to drug development. Researchers can use bioanalytical results to gain an insight into how drugs impact our bodies; any potential side effects or toxicity they might produce; and interactions with other drugs or dietary factors that might reduce effectiveness or safety – this information allows for effective drug discovery processes.
As drug development processes change, so too do sponsors’ needs for bioanalytical services. Sponsors demand CROs develop and use modern and accurate bioanalytical assay methods in their bioanalytical assays. CROs face the challenging task of optimizing methods to achieve performance and accuracy, in addition to maintaining a quality system that ensures all samples are analyzed following 21 CFR Part 58 regulations.
Bioanalytical testing involves an intricate series of procedures, from regular audits and record keeping, through training records and instrument qualification to instrument qualification itself. All this requires time and resources in the Global Central Laboratory Services – which could put undue strain on an organization’s operational budget. As such, outsourcing bioanalytical testing to a CRO may be the better solution.
As a beacon of excellence in bioanalytical testing, Spinos extends its services to the vibrant Biotech Company In Coimbatore. We are dedicated to supporting local biotech companies with accurate and cost-effective solutions, fostering innovation, and contributing to the success of drug development initiatives in the region.
