From small drug molecules to cell and gene therapy, every new drug product needs sophisticated and robust tools to analyze samples with accuracy and precision. Bioanalytical laboratories are one such partner that can incorporate the latest tools and platforms to deliver rapid, accurate, and reliable bioanalytical solutions.
Today, bioanalytics companies have helped drug developers and pharmaceutical companies develop thousands of drug compounds by employing the most advanced systems to assess molecules across different stages of drug development. The current article focuses on partner laboratories such as NorthEast BioLab that specialize in delivering bioanalytical solutions and forming an ultimate relationship for accelerating drug development timelines.
Bioanalytical service providers as your reliant testing partner
Bioanalytical laboratories are actively involved in the development of biologics, vaccines, small molecules, and biomarker studies. They specialize in delivering bioanalytical solutions through intensive assay development, unique protein characterization, and the development of reference standards and materials following current regulatory requirements. Besides, they have extensive knowledge in designing and validating custom assays to match increasing drug development needs through meaningful bioanalytical data.
Biosimilar drug products require extensive experience and broader technical capabilities. Bioanalytical service providers have a deep understanding of regulatory pathways to deliver comparable results between innovative products and biosimilars. Moreover, biologics are more variable than small drug compounds, making analytical methods such as MesoScale cytokine multiplex assays subject to variation. Bioanalytical laboratories have extensive experience adjusting and redeveloping analytical methods to consider variation across critical regions, operators, and instruments. Additionally, bioanalytical laboratories have extensive experience in drug development studies, including safety and efficacy testing and BABE studies to evaluate unique drug properties.
Cell and gene therapy are rapidly entering the market. Developing such complex therapeutics can be challenging. Bioanalytical laboratories have a team of experts who can handle unique research challenges for developing cell and gene therapy. Moreover, bioanalytical laboratories have expertise in handling analytes and drug delivery mechanisms such as oligonucleotides, lipids, nanoparticles, polymerase, targeted delivery mechanisms, enzyme replacement therapy, and CRISPR/Cas9 systems.
Furthermore, bioanalytics companies are well-equipped with technological platforms to rapidly transition drug compounds from early drug discovery studies to later stages of clinical trials. Bioanalytical laboratories are well versed with cell-based assays for a wide range of therapeutic applications, including toxin neutralization assay, neutralizing antibody assay, and biomarkers for a comprehensive list of assay development capabilities.
Other bioanalytical techniques such as chromatography mass-spectrometry, flow cytometry, immunohistochemistry, and molecular genomics are regularly offered by reliable bioanalytical laboratories. These advanced tools can analyze various drug products, metabolites, and biomolecules in diverse biological samples. Moreover, their expertise includes evaluating reactive, unstable, and endogenous analytes employing ultra-high sensitive bioanalytical methods with lower limits of quantitation in the picomolar range.
Conclusion
Bioanalytical laboratory services have custom-built and cutting-edge technology supported by a dedicated team of scientists and investigators to help accelerate drug development projects. Besides, a suit of bioanalytical instruments with appropriate engineering and controls to minimize associated risk factors makes bioanalytical laboratories the ultimate partner for accelerating drug development and biomedical research studies.
