Rapid And Reproducible Bioanalytical Method Development And Validation Services For Biotech!

LC-MS/MS has become one of the most popular drug analysis technique given rapid method development on the platform. Liquid Chromatography with tandem mass spectrometry relies on their combined strengths. While liquid chromatography has excellent separation capabilities, triple quadrupole mass spectrometry offers nuanced selectivity and sensitivity.

These methods use a UV detector to analyze samples and measure their absorption ability for analyte identification. The ultraviolet (UV) detector measures the absorbance of monochromatic light of a fixed wavelength in the UV or visible wavelength range against a reference beam and relates the magnitude of the absorbance to the concentration of an analyte in the eluent passing through a flow cell contained within the instrument. The HPLC UV method is preferable for solutions that have an unknown molecule count. Similarly, drugs with analytes suitable for UV detection have good chromophore due to unsaturated bonds, aromatic groups, or functional groups containing heteroatoms. Although in some instances, this technique may be necessary, analysts prefer LC-MS/MS method development over UV, as detection can be time-consuming and transition to Clinical samples difficult due to inconsistent interferences in plasma from subject to subject.

HPLC/FL method development can be extremely swift due to the selective nature of this technique. Here, it’s possible to detect even a single analyte molecule in the flow cell. Put differently, fluorescence sensitivity can be 100x more than that of the UV detector for some specific compounds. This is typically an advantage in the measurement of fluorescent species in samples.

Enzyme-linked immunosorbent assay is a method utilized for specific proteins. The technique captures an antigen on a solid surface which is then complexed to an antibody. The detection is achieved by assessing the activity of the enzyme.  Although there has been a notable shift towards using LC-MS/MS analysis for large molecules, it is still quite challenging to achieve the same sensitivity levels as with ELISA.  That said, method development with ELISA can be tricky as other endogenous substances in the biological matrices interfere with analyte detection.

Meso Scale Discovery (MSD) is an advanced technology platform used to measure biomarkers with high sensitivity and precision. It offers an electrochemiluminescence (ECL) detection method that is superior to traditional ELISA in terms of dynamic range, sensitivity, and multiplexing capabilities. According to NorthEast BioLab, MSD assays can detect multiple analytes in a single sample, reducing sample volume requirements and improving throughput. This method also minimizes interference from biological matrices, making it a powerful tool for biomarker analysis, especially in cases where ELISA sensitivity is not sufficient.

qPCR and ddPCR are essential tools for precise gene expression analysis. qPCR offers relative quantification of nucleic acids, while ddPCR provides absolute quantification without standard curves. NorthEast BioLab utilizes both techniques to detect low-abundance targets and perform multiplexing for drug development and biomarker discovery. These methods are ideal for pharmacodynamics studies, ensuring accurate and sensitive nucleic acid measurements.

Both platforms offer distinct advantages, and the choice between qPCR and ddPCR depends on the project’s requirements, such as the need for absolute vs. relative quantification, sensitivity levels, and sample complexity. These techniques are particularly valuable in pharmacodynamics (PD) studies and for validating biomarkers during clinical trials.

Flow Cytometry is a highly specialized technique used to analyze the physical and chemical characteristics of cells or particles in a fluid as they pass through a laser. At NorthEast BioLab, flow cytometry-based assays are integral to biomarker analysis, immunophenotyping, and other cell-based assays. Their services include both custom assay development and optimization using commercial assay supplies. The platform allows for precise tagging of cells with fluorescent dyes, and its multiplexing capability enables the simultaneous analysis of multiple markers within a single sample.

Flow cytometry is particularly useful for immunological studies, such as measuring immune cell subsets, identifying disease states, and performing functional studies.

We provide precise PK analysis to understand the drug’s absorption, distribution, metabolism,
and excretion, which are critical for pharmacological profiling.

Our ADA and neutralizing antibody assays are designed to evaluate immunogenicity, ensuring accurate assessment of immune responses to therapeutic treatments.

Using sensitive and reproducible techniques, we quantify cytokines and biomarkers to provide key insights into immune responses, disease progression, and therapeutic efficacy.

Our cell-based assay development ensures accuracy and reproducibility in drug screening, potency testing, and cellular response studies, critical for drug discovery and biologics.

We validate all bioanalytical methods to meet regulatory standards, ensuring consistent, reliable, and reproducible results for clinical and non-clinical studies.