As the number of drug developers and biopharmaceutical companies continues to grow, the demand for outsourcing bioanalytical services will rise proportionately. For drug developers to thrive in such an intense and demanding market, they must identify the right bioanalytical lab partners to support them in their drug development journey. Bioanalytical laboratory services include a diverse range of solutions, such as LC-MS assays, ligand binding assay development and validation, and ddPCR gene expression, to name a few. Hence, the current article illustrates the expertise and knowledge of bioanalytical lab services in accelerating drug development studies.
The role of bioanalytical services in accelerating the development of novel therapies
Increasing demand in the drug development and biopharmaceutical industry continues to drive the need for an outsourcing bioanalytical laboratory. This requirement includes both conventional antibodies and proteins and the development of next-generation cell and gene therapies. New companies and small-scale drug developers have limited internal resources and heavily rely on bioanalytical laboratory services to support their drug development projects. Besides, larger biopharmaceuticals have also started outsourcing bioanalytical services to focus on core expertise while supplementing their bioanalytical studies. Here, bioanalytical laboratory services work as a vital partner in providing support through advanced expertise and technology while conducting routine bioanalysis daily.
For multiple small-scale and medium-sized pharma and biotech companies, the primary challenge is to develop methods and processes to take a molecule with potential biological activity from early preclinical testing to ultimate clinical trials and production. These companies heavily rely on an outsourcing partner to identify and develop necessary assays and test the product through preclinical and clinical stages. Bioanalytical laboratories help drug developers determine an ideal assay for the drug molecule of interest. Analytical laboratory services have conducted studies on a wide range of molecules and assay formats. They can help companies identify assays necessary at individual steps of drug development to minimize both cost and time.
Often, drug developers have analytical tools established for their candidate drug compounds. They want outsourcing partners that can take these existing analytical methods and conduct necessary method qualification and validation. This requirement generally means evaluating the reproducibility, accuracy, precision, and other core assay parameters. Here, bioanalytical laboratory services offer support and expertise in method development and identifying the correct protocols suitable for the type of compound and biological matrices to ensure the resultant assays are fit for purpose, robust, and high performance.
Besides, multiple assays are needed to determine and characterize drug substances for clinical use, such as appearance, identity, PH, concentration, potency, sterility, etc. Although bioanalytical assays are crucial to assess and certify the drug product, quantification and determination of its biological activity are the two most critical assessments that are often customized for each product. All bioanalytical assays should deliver reproducible and reliable results with an acceptable level of specificity, accuracy, and precision. Bioanalytical lab services conduct robust method qualification to identify the optimal ranges for these assay performance attributes.
In Conclusion
Bioanalytical services have the expertise, knowledge, and experience to help drug developers accelerate their journey of developing new therapies.
