Bioanalytical laboratories offer bioanalysis services for quantitating drugs, their metabolites, and biomarkers in complex study matrices. Besides, they are ideal partners for preclinical and clinical testing as well as biosample storage. Most bioanalytical laboratories have a team of scientists and professionals with an excellent track record of delivering rapid and precise GLP, drug development, and clinical services. Hence, drug developers can rely on these laboratories to accomplish R&D projects and provide accurate results. The current article explores bioanalytical laboratories in more detail.
Bioanalytical laboratories supporting drug development studies
Bioanalytical Laboratory have dedicated scientists for conducting preclinical and clinical studies, including IND, NDA, ANDA, and BLA submissions. Besides, they are experts in conducting pharmacokinetic and toxicokinetic evaluations using ligand binding assays or LC-MS/MS services. Other bioanalytical solutions include immunogenicity testing, biochemical assays, biomarker testing, cell-based and cytotoxicity assays, and mechanism of action studies. All the above services are backed by FDA audits, GLP and GCP compliance, and DEA schedule II-V approved bioanalysis lab certification.
Most seasoned bioanalytical laboratories have a successful history of offering bioanalysis services to pharmaceutical companies and drug developers. Due to their nature of work, bioanalytical laboratories are constantly exploring opportunities to partner for new research projects and preclinical and clinical studies. However, their core objective remains to provide high-quality and actionable results within the expected timelines and quoted budget.
Bioanalytical laboratories combine in-house expertise with the scientific team of the partner biotech or pharma companies. Hence, with decades of acquired knowledge and experience with the combination of an in-house partner scientific team, bioanalytical laboratories accurately acquire experimental results and process them to give actionable insights. Besides, all data and partnerships thrive on transparency and trust, and hence, bioanalytical laboratories have established excellence, respect, and integrity in the scientific community.
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Facility and equipments
Bioanalytical laboratories regularly invest in infrastructure and technology to exceed business standards. Often, these laboratories have thousands of square feet of area with substantial space for expansion. They have validated LC-MS/MS and HPLC systems for collecting, processing, and reporting experimental data. Besides, all HPLC units are with fluorometric or ultraviolet detectors.
Other bioanalytical instruments include fluorescence and luminometer plate readers, Biorad and Bio-Plex systems, spectramax plate readers, and Biotek plate washers. Other basic instruments include balances, centrifuges, pH meters, and turbovaps. All equipment is routinely maintained with 24/7 temperature and access control and backed using power generators. Importantly, all databases are secured with robust IT infrastructure.
Therapeutic areas
Bioanalytical assay labs have exposure to a broad spectrum of therapeutic areas. Hence, they have deep expertise in method development and validation for diverse therapeutic areas. They can analyze target analytes in various biological samples with minimal adjustments to current techniques and equipment.
Besides, with an increasing industry focus on oncology, most bioanalytical laboratories are aligning their current innovation and efficiency strategies to meet the rising demands in oncology research and development. Hence, bioanalytical laboratories are at the forefront when it comes to higher productivity and increased success in developing life-saving drugs and therapies.
