Additional regulatory perspectives were contributed by Health Canada representatives during panel discussions.įorum Chairs and Speakers Chairs: Nadine Ritter (president and principal analytical advisor of Global Biotech Experts, LLC), Reb Russell (executive director of molecular and analytical development at Bristol-Myers Squibb Company), and Timothy Schofield (senior fellow in regulatory sciences and strategy for MedImmune) They also provided highlights of relevant examples. Representatives from the US Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) presented their agencies’ expectations for transitions in analytical methods. In January 2014, a CASSS Chemistry, Manufaturing, and Controls Strategy Forum explored technical and quality issues associated with replacement of existing analytical methods by new methods during development - how that transition could be achieved smoothly while maintaining phase-appropriate regulatory compliance. A method introduced de novo is not linked to an existing data set generated by an older method that is being discontinued.
Neither is method-bridging the same as adding a new assay to an existing analytical testing regimen. Method transfers demonstrate comparable performance of a method that exists in one laboratory in another. Note that a method-bridging study is distinctly different from a methodtransfer study. So it is necessary to conduct an appropriately designed method-bridging study to demonstrate suitable performance of the new method relative to the one it is intended to replace. Also, specification acceptance criteria that were based on historical data from the existing method could be affected by the measurement capabilities of the new method.
Thus, significant changes in the method can create a substantial discontinuity between past and future data sets. An added method has no previous data sets, so there is nothing to be “bridged.”īut an existing method is tied to the historical data sets it produced (e.g., for Certificate of Analysis tests) and may still be producing (e.g., for ongoing stability protocols). Note that replacing an existing method is not the same as adding a new method to a release or stability test panel.
These methods include both classical and state-of-the-art technologies as well as new technologies as they emerge over time.During the life cycle of a product, several reasons can arise for making changes in existing analytical methods: e.g., improved sensitivity, specificity, or accuracy increased operational robustness streamlined workflows shortened testing times and lowered cost of testing.
To monitor the control and consistency of products derived from biological systems, a broad array of analytical methods are used for biopharmaceutical release and stability testing.
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