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Assay development (custom assay development)

Working on difficult Method Transfer or need assay validation for a custom assay? 

 
BioReliance can provide custom Assay development services for pre-clinical and clinical studies, in accordance with international testing guidelines and regulations.  BioReliance’s CRO experts will work with you through all stages of custom assay development, providing you with high-quality data and quick turnaround time from design through completion.
 

Custom assay development services include:

  • Method transfer
  • Assay validation
  • Assay qualification

 

BioReliance's staff have performed numerous custom assay development studies for clients in BioPharma.  At BioReliance every protocol is designed to meet each study and customer’s specifications.

 
What custom assay development services does BioReliance offer?

The BioReliance CRO research team will help you customize and develop comprehensive assays to accommodate nearly any type of biological or analytical parameters required.


Custom assay development services include:
• Virology assay development services
• Microbiology assay development services
• Toxicology custom assay development services


Method transfer
The FDA has released an official guide on how to conduct and document method transfer. If you are transferring a validated method between laboratories and sites, assays will need be maintained and re-validated to ensure the same reliable results in the receiving laboratory.  The receiving laboratory also must provide documented evidence, or an AMT (Analytical Method Transfer), that the assay performs to standard. The BioReliance team can help you through the most likely failures during method transfer and provide custom protocols to fit your needs.