Assay development in drug discovery and development help companies develop safe and effective drug products. A robust assay qualification and development is integral to every pharmaceutical and biotech company. However, many companies fail to allot substantial resources and time needed to generate reliable bioanalytical assays. Hence, having a trusted assay development company providing robust bioanalytical solutions is crucial, particularly for these companies.
Reliable assays are needed at every step of the drug discovery and development process. From conducting biomarker assay testing to following bioanalytical method development guidelines, a dependable partner laboratory may help integrate assays into preclinical and clinical studies. Today bioanalytical labs develop a spectrum of assay methods, including MSD-ECL, ELISA, LC-MS, and Luminex. The current article explores various services offered by an assay development company.
A robust assay development laboratory becomes a part of your team. Whether the project is focused on developing commercial products or academic research, assay development companies can help streamline the project. Besides being in the assay development industry, they have extensive experience developing and validating different assay methods. Assay development companies employ the latest technologies in the field of bioanalytical assays. Moreover, they are experts in handling different types of study samples and probes.
Developing a reliable assay requires in-depth expertise in various technical avenues. From early assay concepts to post-production support, assay development companies are available for assistance. An assay development company can contribute to early-stage assay development, assay qualification and validation, and support manufacturing to develop the most precise and accurate bioanalytical assays.
Micro-array-based assays are used widely in biomedical research. These assays can assess multiple analytes, including cell lysates, small molecules, oligo probes, clones, antigens, antibodies, peptides, and proteins. Assay development companies specialize in placing numerous probe types into arrays that result in the development of high throughput microarray-based assays. Besides, many assay development laboratories assist in transferring traditional ELISA assays to more modern assay formats.
Assay development companies exercise their extensive assay development and manufacturing capabilities to develop and deliver bioanalytical assays for commercial and research applications. Array based-assays have numerous applications, such as:
- Autoimmune disorder profiling
- Prognostic and diagnostic expression profiling
- Identification of pathogens
- Analyte screening
Diagnostic and prognostic assays
Diagnostic and prognostic assays provide valuable information that can improve patient outcomes in medical settings. A robust bioanalytical assay can provide reliable diagnosis or treatment based on clinical data. Besides, a reliable assay method can provide affordable and accurate testing of clinical samples. An assay development company can bring expertise to developing and validating bioanalytical assays. These assays can have a broad range of applications, such as diagnostic expression profiling to identify cancer sub-types and prognostic expression profiling to identify specific therapies for these subtypes.
Generally, assay development companies begin with a typical pilot project during the initial phase of diagnostic and prognostic assays and ensure that the developed assays are robust and specifically targeted to the intended application. An assay development laboratory will always focus on identifying elements that may influence assay development and validation.