Abstract

Bioanalysis is determining the concentration of drugs and metabolites in biological fluids (i.e. plasma and urine). During the past 15 years tremendous advances in bioanalysis, for example HPLC, auto injectors, data collection systems and robotics has enabled the productivity of the bioanalyst to increase but it still requires considerable manual intervention. This paper describes the rationale, the justification and the plans Bristol-Myers Squibb has to completely automate the entire bioanalytical process.

Highlights

  • HPLC, auto injectors, data collection systems and robotics has enabled the productivity of,the bioanalyst to increase but it still requires considerable manual intervention

  • This paper describes the rationale, the justification and the plans Bristol-Myers Squibb has to completely automate the entire bioanalytical process

  • When HPLC was introduced in the 1970s, it proved to be a fantastic technological advance in bioanalysis because it offered specificity without the need tbr chemical derivatization

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Summary

Sample Storage

Transfer Samples to Lab reate an Analytical Run "]arnple Analysis [_mple Re-st0rage. laboratories. Without the use of robotics the typical in-house analyst can prepare a bioanalytical run every other day. During 1992 about 63000 samples were sent to contract bioanalytical laboratories for bioanalysis for two reasons.-First, Bristol-Myers Squibb has inadequate facilities for handling samples known to be HIV+. It should be stressed that sending samples to contract laboratories for bioanalysis only saves about two thirds of the resources that would be used for in-house bioanalysis. The analyst in Bristol-Myers Squibb is still responsible for verifying the bioanalytical results and for getting the data in a format for subsequent pharmacokinetic analysis. It costs on average about $38 per sample for outside contract bioanalysis. During 1992, Bristol-Myers Squibb spent $2.4 M dollars on bioanalytical contracts

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