PHARMACEUTICAL MANUFACTURING: NEW TECHNOLOGY OPPORTUNITIES.. G.K.Raju, Ph.D. Executive Director, Pharmaceutical Manufacturing Initiative (PHARMI), MIT Program on the Pharmaceutical Industry, Massachusetts Institute of Technology

2/7/02


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Table of Contents

PHARMACEUTICAL MANUFACTURING: NEW TECHNOLOGY OPPORTUNITIES.. G.K.Raju, Ph.D. Executive Director, Pharmaceutical Manufacturing Initiative (PHARMI), MIT Program on the Pharmaceutical Industry, Massachusetts Institute of Technology

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PROCESS D: BLENDING PROCESS DEVELOPMENT

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PROCESS A WITH QC TESTS

PROCESS A WITH CYCLE TIMES

PROCESS D WITH QC TESTS

PROCESS D WITH CYCLE TIMES

PROCESS D WITH QC TESTS: Cycle Times including BULK ACTIVE

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PROCESS E WITH QC TEST TIMES

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PROCESS F: LIQUID LINE WITH CYCLE TIMES

OVERALL CYCLE TIMES: QC TESTING TIMES ARE SIGNIFICANT

CYCLE TIME COMPONENTS

ON-LINE TECHNOLOGY IMPACTS DOMINANT CYCLE TIMES

WHAT DRIVES THE QC TESTING TIMES?

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PHARMACEUTICAL MANUFACTURING: LOOKING BEYOND THE “AVERAGE”

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OVERALL CYCLE TIMES: QC TESTING TIMES ARE SIGNIFICANT

Pharmaceutical Manufacturing: Impact of Exceptions

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PHARMACEUTICAL MANUFACTURING: The New Technology Opportunity..

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ACKNOWLEDGEMENTS

NOTE ON CONTEXT

Author: James C. Leung