This article presents an approach for managing raw materials in the QbD paradigm. It should be understood that risk assessments
are limited by what is known at a given point in time. In a recent example, it was noted that the distribution of peaks on
a column in the purification train showed differences after a process transfer from one site to another. Although it caused
no difference in product functionality, the cause of the variability was sought. After investigation, the two sites were found
to be using different sources for a media component. Further investigation showed that the two sources differed in their content
of a trace metal ion, which was a cofactor for an enzyme whose activity could explain the differences in peak distribution.
Continuous monitoring of processes and the use of techniques such as multivariate data analysis are prerequisites for continuous
improvement and superior process performance.9–12
The authors would like to thank Jennifer Mercer, Amgen Inc., Thousand Oaks, CA, for her review of the manuscript and her helpful
Anurag S. Rathore, PhD, is a biotech CMC consultant and a faculty member at the Indian Institute of Delhi, India, +91-9650770650, email@example.com
. Rathore also is a member of BioPharm International's editorial advisory board. Duncan Low is a scientific executive director in process development at Amgen Inc., Thousand Oaks, CA.
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