HEALTH

Assay Development Services Unveiled: Taking Your Research to the Next Level!

Assay development services are critical for drug discovery and development processes. Reliable assay development and validation can make or break a drug development campaign. Assay development services are crucial for laying the foundation for a successful drug development project. 

Assay development services have in-depth expertise in designing and developing custom assays. Besides, with an extensive experience in analytical assay development, bioanalytical laboratories can help design and deliver robust bioanalytical solutions. The current article explores assay development services and assesses the possibility of transitioning your research projects to the next level. 

Assay development services

From in vitro assay development to fully validated clinical assays, scientists at bioanalytical laboratories can help sponsors identify the right assay type for relevant compounds, establish stringent quality controls and define appropriate study criteria. 

Assay development services have a robust structure to meet your timeline and budget. Before initiating any project, assay development services first understand all initial requirements, study objectives, and project scope and then recommend an ideal course of action. Moreover, many assay development services offer fee-per-service contracts to minimize timelines and maximize the budget. Moreover, many assay development services have a full-time project manager serving as a single point of contact and being available for additional services and requirements. 

Assay development services have deep expertise in both custom assay development and using pre-validated assay kits. For analytes present in a pre-validated assay development kit, scientists can effectively identify and conduct bioanalysis for the analytes of interest. In other cases, investigators can develop a bioanalytical assay from scratch when novel assay development is required.  However, sponsors often think that custom assay development will be more expensive. But in reality, this is not the case. Custom assay development is often a black box for drug developers, especially small and medium-sized pharmaceutical companies. Assay development services are experts in custom services. Drug developers may spend up to 6 months on a single custom assay development, whereas experts in bioanalytical laboratories could deliver a custom assay in a few weeks. 

Moreover, researchers often need help adapting research assays in a clinical setting. Development services can effectively modify standard operating procedures, qualify reagents and standardize and validate protocols to meet changing requirements. 

However, a well-designed and customized assay needs to consider several factors. Following are some considerations assay development services always focus on for reliable bioanalysis. 

  • Availability and stability of reagents
  • Validity and availability of control samples
  • Appropriate pharmacology signal stability to deliver robust assays
  • Assessing volume, reagent cost, and availability of plate formats before beginning assay development
  • Evaluating screening concentration, false positive and false negative and predicting activity thresholds to instill confidence in hit rate
  • Ensuring scalability through automation
  • Reliable data handling via error typing and reporting of accurate results
  • Orthogonal and selectivity assays for progressive hit compounds

Scientists at assay development services are skilled at assessing client requirements and recommending custom solutions to overcome challenges in assay design and development. Hence understanding assay development services is crucial for taking drug research and development to the next level. 

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