Generating rapid and accurate bioanalytical results is essential for accelerating drug development. From early drug discovery studies through preclinical assessment and clinical trials, evaluating drug behavior and exposure is critical for dose selection and accelerating compounds to the commercialization phase. Using robust bioanalytical methods, researchers can analyze and process biological samples to determine and quantify the drug compounds of interest. However, due to the unprecedented rise in demand for novel drug products, pharmaceutical companies and drug developers are increasingly outsourcing studies to bioanalytical laboratories.
Bioanalytical lab services are experts in developing assays and techniques such as PK assay development and immunogenicity testing. Bioanalytical labs have a dedicated team of scientists with experience supporting drug candidates in all stages of drug development. They help their sponsors gain a clear understanding of the drug compounds through preclinical models, in vitro testing, healthy volunteers, or patient populations. The current article discusses the role of bioanalysis labs in drug development and clinical trials.
Bioanalytical laboratories accelerate drug discovery and development.
Bioanalytical method development is often a black box for several small-scale pharmaceutical companies. Robust method development requires intense expertise and an in-depth understanding of target analyte behavior in diverse biological samples. Compared to standard analytical testing, bioanalysis involves largely undefined and highly complex biological samples with millions of sample components that may influence the accurate and specific evaluation of target analytes.
The required expertise and understanding to navigate bioanalysis may not necessarily be available in-house, especially when the regulatory scenario around bioanalytical studies changes rapidly. Additionally, bioanalytical testing is moving towards MS-based analysis, which requires expensive instrumentation and specialized training for data analysis, which may not be possible for several small-scale and mid-size drug development companies.
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Moreover, most bioanalytical testing is conducted under good laboratory practices, and hence, bioanalytical laboratories performing the studies must adhere to 21 CFR 58. This requirement requires companies to have a quality system, regular facility audits, and maintenance of documentation, instrument qualification, training records, and much more, which can often be challenging for companies and drug developers with limited operational resources and budgets. Hence, it becomes simpler to partner with a bioanalytical laboratory with expertise in bioanalysis and an already-established quality system that fulfills the requirements required by the FDA and other regulatory agencies.
Partnering with bioanalytical laboratories has several benefits. Often, drug developers exceed their bioanalytical capacity and hence require an outsourcing partner lab that could complete the remaining bioanalytical testing. Besides, drug developers may lack specific equipment or analytical experience, and a contract laboratory will be able to fulfill that service or expertise. Contract research organizations are especially beneficial for smaller drug developers and biotechnological companies as they can provide valuable consultation and an expanded service offering, which can be a one-stop solution for all their bioanalytical needs. Besides, reliable bioanalytical laboratories have worked on multiple assay formats and research projects. Hence, they are more exposed to global regulatory practices and are frequently audited by regulatory agencies.
