Bioanalytical Assay Development and Validation

Bioanalytical Assay Development and Validation

INQUIRY

Creative BioMart provides comprehensive method development and validation services for small and large molecule bioanalysis to accelerate kinase and phosphatase drug discovery and development. Our firsthand knowledge, advanced technology platform, proven protocols, and extensive experience ensure that we can accommodate our customers’ needs for bioanalysis.

Background

Bioanalysis is the process from sample collection, sample analysis to data reporting. Bioanalytical assays can be used not only for the analysis of small molecules such as drugs and metabolites in biological samples but also for the analysis of large molecules such as proteins and peptides. Techniques involved in bioanalysis allow reproducible and reliable identification and quantification of analytes in various biological samples, such as blood, plasma, serum, saliva, urine, feces, skin, hair, and organ tissue. Given its ability to address the identity, purity, potency of these analyses, bioanalysis has become an essential part of drug discovery and development and is critical to the success and timing of any pharmaceutical program.

The goal of bioanalytical assay development and validation is to find a suitable method applicable to a selected analyte in a specific biological matrix. The results obtained from bioanalytical assays may be inaccurate and unreliable due to low sensitivity, low specificity, and other reasons, and therefore these assays need to be validated to ensure that the data obtained can support the intended purposes.

What We Offer

Creative BioMart has established an integrated technology platform covering LC-MS/MS, LC-UV, UPLC-MS/MS, SFC-MS/MS, HPLC, GC-MS, immunoassays, and other technologies. We offer comprehensive method development and validation services for small molecule and macromolecular bioanalysis. Our talented scientific team has an excellent track record of customizing bioanalytical assays for drug discovery and preclinical development.

• 

  Bioanalytical Assay Development

  We offer a full range of assay development services for sample preparation, separation, and detection for bioanalysis. Our scientists are constantly developing assays for both small and large molecules across many technology platforms. We are specialized in developing chromatographic bioanalytical assays, mass spectrometric bioanalytical assays, quantitative bioanalytical assays, and ligand binding assays to help our customers develop novel drugs targeting kinases and phosphatases.

• 

  Bioanalytical Assay Validation

  We can perform full validation, partial validation, and cross-validation to help our customers fully ensure that each bioanalytical assay can yield robust and reliable data. Specificity, sensitivity, precision, accuracy, linearity, recovery, stability, and reproducibility are important parameters that we consider in bioanalytical assay validation. We apply our knowledge, skills, and experience to help our customers meet their timelines and regulatory requirements.

Creative BioMart has a scientific team with many years of experience in kinase/phosphatase biology research and drug development who will work closely with our customers to develop and validate bioanalytical assays for their cutting-edge research. If you need any further information, please feel free to contact us at any time. We will get in touch with you as soon as possible.

References

• Moein M M, et al. Bioanalytical method development and validation: Critical concepts and strategies. Journal of Chromatography B, 2017, 1043: 3-11.
• Deshpande M M, et al. Bioanalytical Method Development and Validation: A Review. Recent Advances in Analytical Chemistry, 2019: 97.