An assay development scientist is vital in bringing a candidate drug from the discovery stage to the post-marketing phase. Hence, assay development service providers like NorthEast laboratories focus on acquiring and retaining expert assay development scientists. Assay development companies have a core team focusing on assay development and study sample analysis. Here assay development scientists help assess the development of bioanalytical assays and interpret the resulting data.
Assay development scientist has numerous duties within a bioanalytical testing setting. However, when searching for a biolab near me, sponsors must also evaluate whether the partner bioanalytical testing services have an expert panel of assay development scientists. The current article highlights the various roles of assay development scientists in a bioanalytical lab.
The role of assay development scientists
Assay development depends on the availability of assay reagents. Hence, assays for the early drug discovery phase may differ from the later stages of drug development. Often, early studies are conducted through fit-for-purpose assays. Once a specific sassy is better qualified and adapted, it is validated for later GLP studies. As the drug molecule moves towards clinical trials, a more robust assay is considered for the human matrix.
The primary role of assay development scientists is to develop and validate bioanalytical assays for robust analysis of study samples. Sensitivity requirements are one of the first parameters needed to define an assay. The bioanalytical scientist first identifies the sensitivity requirements based on a literature search before testing the method to obtain true sensitivity. Both the assay method and reagents will define assay sensitivity. Hence, assay development scientists define the initial terms of assay platform and investment. Particularly, the scientist matches the assay development and validation timelines to support necessary drug development milestones.
Assay development scientists support the discovery phase of drug development through several generic assays. This support allows rapid sample analysis during early in vivo studies. Generally, these generic platforms are ligand-binding assays or LC-MS/MS systems. Ligand binding assays identify the Fv or Fc portion of the biotherapeutic. On the other hand, LC-MS/MS analysis is used for complex structures to obtain an initial concept during the early stages of drug development.
If immunogenicity interferes with PK interpretation, assay development scientists complement PK analysis using ADA assays. However, often project-specific bioanalytical assays are needed. For instance, generic assays, such as mouse surrogate formats, may not meet project demands or are challenging to implement, Generally, biotherapeutic methods must be measured in sample analysis, though this will depend on the availability of assay reagents.
During the discovery phase, assay development scientists employ a total assay to recognize common epitopes. Once ADAs are available, more specific assays are developed. During the transition to the clinical phase of drug development, changes in reagents and study matrix will lead to changes in the bioanalytical method. Eventually, batch reproducibility, reagent stability, and supply are crucial factors for developing assays in clinical trials.
Assay development scientists have a vital role in bioanalytical laboratories. Hence, reliable assay development partners, such as NorthEast labs, always concentrate on having expert assay development scientists on their panels.
Must Read: Array Of Services Offered By An Assay Development Company
