BIOT 167 |
| Design Space and Critical Process Parameters (CPPs) are familiar terms but have yet to take on a precise, universally understood meaning in our industry. This presentation is an exploration of one company's challenges in identifying CPPs, positioning them in regulatory submissions and understanding the risks and benefits of doing so. The CPP identification process begins during process development where Design of Experiments is used to understand the sensitivity of Critical Quality Attributes (CQAs)to wide ranges of critical and non-critical Process Parameters. Scale-up and technology transfer require a CPP risk assessment using the principles of Quality Risk Management to prioritize those Process Parameters that require the tightest control. Process validation then demonstrates the ability to consistently control CPPs at the commercial scale. Reduced scale process validation studies demonstrate the ability to manufacture product within specified CQA ranges when CPPs vary over their proven acceptable ranges. The validated CPP ranges may then be used to help define a Design Space for regulatory submissions. |
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Commercialization of Biologics: Impact of Design Space Philosophy & Emerging Regulations on Process Validation
3:00 PM-5:20 PM, Tuesday, August 21, 2007 BCEC -- 108, Oral
Division of Biochemical Technology |