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BioTech Product: PAT - Process Understanding & Characterization

Capability

Biotech Support
Regulatory, Compliance & Quality
Technical Services

Client

Global top-tier pharmaceutical company with monoclonal antibody based product.

Problem

A statistical shift downward in fermentation yield suggested an uncontrolled variation in an unknown critical process parameter. Because trend analysis was not routinely monitored, the problem was not noticed quickly. 

Approach

Eighty process parameters were examined for correlation with yield using multi-variate analysis techniques (35 input variables, 35 in-process, and 10 derived variables). Control charts, correlation plots, process flow diagrams, focus interviews and other tools and techniques were also used to more fully characterize the process. Three variables were found to explain 76% of the variation in yield. Two of those variables related to variation in raw material characteristics, including protein and specific ion levels.

Results

Working with Tunnell to achieve tighter control over raw material characteristics, the client realized significant benefits, including:

• A 30% increase in yield 
• More than $10MM in savings and capital expenditures, including avoiding a facility expansion                                                                                                                                            
• Significant increase in process understanding of the fermentation process
• Lower compliance risk
• Implementation of a new process control strategy

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