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BioTech Product: PAT--Process Understanding & Characterization

Capability

Biotech Support
Regulatory, Compliance & Quality
Technical Services

Client

Global top-tier pharmaceutical company on the verge of launching a blockbuster pegylated peptide based product.

Problem

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. 

Approach

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.

Results

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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