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Process is Our Product



 

   
 
Process is Our Product PDF Print E-mail
Commitment To Quality - Process Control at ReaMetrix
At ReaMetrix, we have built a world-class research and development facility in Bangalore, India with a primary focus of applying Six Sigma product development strategies to diagnostic and life science products. We believe that process control is a critical component of generating high quality data and products. Our corporate infrastructure is process-centric, and we live by our philosophy on a daily basis. Rigorous documentation, full audit trails, and a dedicated quality group result in high quality products, and reproducible, trustworthy data. At ReaMetrix, Process is our Product.
 
 
  • ISO 9001 Certified
  • Six Sigma Product Development Strategies
  • Full Audit trails for product development and contract research projects
  • GMP level manufacturing processes
 
 
Application of Six Sigma
The application of Six Sigma and Process control to the development of biological products has allowed ReaMetrix to develop and apply a stable and repeatable methodology of producing fluorescent reagents. By adhering to Six Sigma principles, it has been possible to define the relationship between assay parameters in order to optimize the manufacturing process for the the most reliable and robust assay. While the objective is to selectively label antibodies as brightly as possible with a minimum quantity of reagents, many characteristics of assay components determine the outcome. In the development of fluorescence based assays for cellular detection and sub-classification, the primary objective is the maximization of specific signal above the noise background. To achieve this maximum, a balance between achievable D/P ratios, impact of dye quenching, and impact on native antibody affinity must be thoroughly vetted.
 
 
In addition to quality, process control can be applied to cost management. With a robust and repeatable reagent MOP (manufacturing operating procedure), it is possible to optimize the selection of dyes to include newer candidates free of intellectual property constraints. Additionally, cost reduction has been achieved by the elimination of cold-shipment requirements as a result of modifying the MOP to include drying down reagents onto the bottom of the assay tube. The the robust and cost-effective dry-down process provides the reagent in a dry, unitized format and eliminates many potential sources of error.
 
 
A .pdf version of our Quality Policy can be downloaded here.
 
 
A .pdf version of our ISO 9001 Certificate can be downloaded here.
 
 
 
 
To inquire about our services,please contact us at custom@reametrix.com
+01 650 620 9253 x 109 (USA)
+91 80 2837 8693 x95 (India)
 
Copyright 2008, ReaMetrix.