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PHARMACEUTICAL INDUSTRY :
Product Development Support |
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Client: |
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A
major consumer pharmaceutical developer, manufacturer and supplier,
with a focus in pain treatment. The client supplies products in multiple
dosage forms, with total global revenues exceeding $1 billion annually. |
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Problem: |
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The
firm was gearing up for validation batches in preparation to launch
a controlled-release drug for the treatment of pain - but they were
experiencing some intermittent R&D batch failures relating to
dissolution. |
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Approach: |
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Tunnell Consulting arrived with a team consisting of a pharmaceutical scientist, a statistician, a process engineer, and a data analyst. This team followed a formalized and structured methodology for identifying the root causes of process and raw material variation. Historical data spanning more than 75 process and raw material variables and corresponding to more than 15 R&D and production-scale batches was mined and entered into a comprehensive database. Process control charts were developed and analyzed. Process capability analysis was performed. Both process and raw material variables were prioritized based on multiple-regression analysis and insight from Tunnell scientists.
Neither the consistency nor the amount of the historical data was sufficient to quantitatively characterize all of the key drivers of dissolution with high confidence. This created the primary impetus to develop an experimental design that would provide the necessary understanding of the critical process relationships.
Based on the prioritized list of potential causes of variation, a comprehensive Design of Experiment (DOE) was developed. The Tunnell team designed the experiment, wrote the experimental protocol, and detailed the proper sampling and analytical testing plans. Tunnell process engineers assisted in the execution of the experiment -- from the raw material preparation to the drug production process itself. The DOE was essential in establishing the critical process relationships. |
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Results: |
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The client successfully launched the product in January, 2005, less than 6 months after the DOE campaign began. In addition to the obvious benefit in launching the drug, the effort spent defining and understanding the technologic space available provided critical technical input for a successful technology transfer and for achieving process robustness going forward. |
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