Inside Bio Analytical Lab – A Comprehensive Guide

Bioanalysis is an essential component of characterizing the pharmacokinetic/pharmacodynamic characteristics of chemical entities from their discovery through various stages of drug development. For an effective analysis, GLP must always be observed throughout.

GLP compliance extends well beyond the laboratory bench, including record keeping, sample shipping and storage stability, study management and more. Many laboratories rely on LIMS systems to protect data integrity.


No matter whether your project involves small molecules or large, accurate bio analytical service is critical to its success. From discovery through preclinical, GLP toxicology and PK studies and submission for clinical DMPK submissions – accurate bioanalytical methods provide crucial confidence that products are moving forward safely and effectively.

To achieve optimal analytical performance, your bioanalytical system must be highly sensitive, with outstanding separation and detection capabilities. Liquid chromatography coupled to mass spectrometry systems have proven their superiority over other measurement technologies in terms of separation efficiency and sensitivity and can offer both qualitative and quantitative measurements simultaneously.

Sample preparation is a central aspect of bioanalytical analyses. This process seeks to increase analytes while eliminating interfering substances and creating more easily detectable species for separation and detection. Choosing an extraction procedure depends on both analyte type and sample matrix – dilute-and-shoot extraction is one method available while others include protein precipitation or solid phase extraction.

Development, qualification, and validation of analytical methods is an intricate task, requiring expertise across various scientific fields. When setting up or revamping an existing bioanalytical laboratory to full Good Laboratory Practices (GLP) status it’s critical that you fully comprehend its regulatory requirements; how they pertain to your specific bioanalysis process; and a rigorous method development, qualification, and validation protocol can help meet them successfully. That is why pharmaceutical companies enlist specialist bioanalytical laboratories that possess this insight to meet timelines more successfully and adhere to guidelines more easily and keep timelines on schedule.


Drug development necessitates accurate and reliable methods for measuring analytes in biological samples such as plasma, urine and whole blood. Such bioanalytical methodologies form the backbone of any new chemical entity’s pharmacokinetic/pharmacodynamic evaluation and regulatory submissions needed for commercialization.

Skilled scientists employ highly sensitive techniques like liquid chromatography with tandem mass spectrometry to produce bioanalytical results. These advanced analytical platforms enable us to detect low concentrations of investigational compounds across a wide array of matrix substrates.

Dependent upon the sample type, various extraction methodologies may be utilized to prepare it for analysis. Proper extraction ensures accurate selection of analytes; improper extraction could adversely impact data results and compromise bioanalytical processes as a whole.

Laboratory staff must abide by Good Laboratory Practice (GLP) guidelines to ensure the highest-quality results, which includes validating equipment, maintaining chain of custody and documenting all records accurately. In order to protect sample integrity and the results from bioanalytical analyses, samples should also be shipped and stored appropriately in order to prevent issues that might compromise its integrity and the resulting data.

Every analytical run includes quality control samples compared with their original sample to ensure that storage conditions such as room temperature or autosampler, freeze-thaw cycles or long-term storage do not compromise analyte concentration or analysis results. At NorthEast BioLab, this includes testing sample stability at various temperatures during both thaw-freeze cycles as well as long-term storage stability testing.


Accurate and reliable bioanalytical testing are essential in the pharmaceutical industry. GLP-certified bioanalytical laboratories must possess various tools, technologies, and procedures in order to process samples efficiently while producing quality results quickly.

Drug discovery and development involves complex chemical interactions that require both people and technology to ensure data integrity. A bioanalytical laboratory’s duties include sample processing, method development and reporting as well as managing facilities, equipment and compliance to guarantee quality results are achieved.

As researchers prepare their drugs for clinical trial, they must collect accurate PK and TK studies data. To do this, several steps need to be taken: first developing, qualifying and validating a bioanalytical method capable of quantifying an analyte within its given biological matrix; and second creating and qualifying and validating an appropriate bioanalytical test procedure that measures it accurately.

Method validation is an integral step in the drug development process, and must adhere to FDA and Health Canada guidance in order to produce reliable data. Validation requires extensive verification including method performance, assay precision, accuracy, recovery, selectivity and matrix effect analysis.

Hughes and her team at BioPharma maintain rigorous standards for themselves and the studies they perform for clients. They consistently attain 98 percent passing batches and reach 100% reproducibility rates regularly.

The Chemistry Laboratory is equipped with Hamilton Nimbus workstations and nine SCIEX LC-MS instruments from SCIEX; four API 4000s and five QTRAP 5500s from their QTRAP series are located here, optimizing sample transfers between freezers for efficiency. Smart-Vue Wireless Monitoring ensures all samples stored safely.


An accurate understanding of the biological and clinical impacts of investigational drugs is integral to making go/no-go decisions during drug development, necessitating highly accurate quantification of analytes and their metabolites in various biological matrices using robust, validated bioanalytical methods. Unfortunately, developing and validating CMC (chemistry, manufacturing and controls) assays is time consuming – automating workflows associated with quantitative bioanalysis will drastically decrease turnaround times while increasing quality.

At a round table discussion, it was suggested that instrument vendors could utilize CROs and Pharma labs as test beds when developing new technologies for specific applications. This approach benefits all parties involved by giving CROs and Pharma labs the chance to test instrumentation that delivers assay sensitivity, performance and software functionality within an integrated platform while instrument vendors gain insight into how these new technologies will fit within a regulated environment and can best meet customer demands.

Although panelists agreed that quality, scientific value and relationships were their top motivators in selecting labs, there is considerable ongoing pressure from Pharma procurement groups to reduce costs due to decreased research and development budgets.

Some of the biggest pharmaceutical companies rely on third-party partners to meet their deadlines for method development and validation. Laboratory services also have the added advantage of having insight into regulations as well as questions from regulatory agencies; this visibility can provide more rapid responses to any changes in guidance that arise, making selecting an ideal partner all the more crucial.


The Discussion section of your lab report should showcase your strength of scientific reasoning and your mastery of its concepts. Here you should make clear judgments regarding the hypothesis of your experiment while explaining your reasoning through results from Procedure and Conclusion sections as well as any comparisons with previous work (whether other students in your lab or published scientific studies). Additionally, be sure to provide convincing evidence supporting any claims you make here.

Bioanalytical methods must be validated according to their intended use within the context of regulatory guidelines and laboratory-specific Standard Operating Procedures. Validation should take into account both physiochemical properties of an analyte being measured as well as specific analysis requirements such as LLOQs or matrix analyses.

Furthermore, bioanalysts are increasingly paying close attention to activities that contribute to assay accuracy such as sample collection in accordance with protocols, sample stability testing on patient/subject and control matrices, as well as thorough NSB testing on those matrices. Although such activities cannot be directly controlled or managed by them, bioanalysts must ensure they are monitored.bioanalytical services companies data quality is key for the successful development of pharmaceutical products and medical devices. Achieving high standards of data integrity can be challenging; failing to meet those standards could delay projects reliant on such data such as Phase 1-4 clinical trials. A laboratory information management system compliant with regulatory guidelines may help mitigate some risks by overseeing record keeping, sample shipping, stability, study management and more.

Bioanalysis is an essential component of characterizing the pharmacokinetic/pharmacodynamic characteristics of chemical entities from their discovery through various stages of drug development. For an effective analysis, GLP must always be observed throughout. GLP compliance extends well beyond the laboratory bench, including record keeping, sample shipping and storage stability, study management and more. Many laboratories rely…