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BIOTECH PRODUCT :
PAT – Process Understanding
and Characterization |
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Client: |
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Global top-tier pharmaceutical company on the verge of launching a blockbuster pegylated peptide based product. |
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Problem: |
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Inconsistent batch-to-batch quality led to efforts to characterize and optimize the manufacturing process with a focus on yield improvement in anticipation of the need to meet impending market demand. |
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Approach: |
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Although the product was in very late-stage development, sufficient process characterization had not been performed. As a result, critical process parameters remained “hidden” and uncontrolled. There was too much uncertainty about which of the 20 input variables (buffer characteristics, flow rates, protein load, reagent-to-protein ratio, etc.) were the critical ones driving variation in the key release parameters (CM chromatography yield, titer etc.). Multi-variate statistical analysis study successfully identified these “hidden” parameters and determined that one variable – column loading – accounted for more than 61% of the variation in CM chromatography yield. |
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Results: |
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Working with Tunnell, the client achieved significant benefits, including:
Prospective experimentation related to column loading that resulted in an
increase of 5% in yield
Lower compliance risk
Fewer batch rejections
Identification of other parameters, for which data had not been reported, that
were also driving variation in yield and were candidates for a series of designed
experiments
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