Correlating Product Lifecycle and Manufacturing Site Characteristics with Critical-to-Quality Product Deviations - Pharmaceutical Technology

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Correlating Product Lifecycle and Manufacturing Site Characteristics with Critical-to-Quality Product Deviations
MIT survey results address product and site characteristics that statistically correlate with quality performance.

Pharmaceutical Technology
Volume 36, Issue 9, pp. 72-75


With the intent of increasing understanding of variables associated with commercial quality performance of individual biopharmaceutical products, a survey was conducted with questions related to the product lifecycle and site characteristics. The interim analysis presented here was based on 34 products across 11 sites with diverse characteristics.

The analysis focused on determining which product or site variables were statistically more likely to be present for products that have experienced a critical-to-quality defect at the commercial scale. The themes of variables found to be statistically significant based on the likelihood analysis were:

  • A history of quality issues in the product lifecycle
  • The geographic region of manufacture
  • The manufacture in a contract manufacturing site
  • Distribution of technical personnel at the site (particularly employed in QA and employed in manufacturing).

A number of themes not found to be statistically significant for association with commercial critical-to-quality defects, based on the data available, include:
  • Perceived complexity of the product and process
  • Use of QbD earlier in the product lifecycle
  • Number of batches manufactured in the past five years at the commercial scale.

The CBI MIT research is ongoing, both specific to this survey and more generally regarding the understanding of product quality.

For more information

To take the survey on behalf of a biomanufacturing site, use this link: Or contact MIT CBI at
, tel. 617.253.0257.

Reuben D. Domike is affiliated with the Center for Biomedical Innovation (CBI), Massachusetts Institute of Technology (MIT), and the School of Business at the Univ. of Prince Edward Island; Jeffrey T. Macher is affilated with CBI, MIT, and the McDonough School of Business at Georgetown Univ.; Paul W. Barone and Stacy L. Springs are affiliated with CBI, MIT; Anthony J. Sinskey is affiliated with the MIT Department of Biology; and Scott Stern is affiliated with the MIT Sloan School of Management.


1. FDA, "Risk-Based Method for Prioritizing CGMP Inspections of Pharmaceutical Manufacturing Sites—A Pilot Risk Ranking Model" (FDA, Rockville, MD), (2004).

2. R. Domike et al., Bioprocessing & Sterile Mfg., supp. to Pharm. Technol. 36 (5) s12 (2012).

3. L. Yu, Pharm. Res. 25 (4) 781–791 (2008).

4. M. Hermanto, R. Braatz, and M Chiu, AIChE Journal 57 (4) 1008–1019 (2011).


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