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Methodologies for the transfer of analytical methods: a review
1Laboratory of Analytical Chemistry, CIRM, Department of Pharmacy, University of Liège, B-4000 Liège, Belgium.
Summary
This paper reviews analytical method transfer challenges and strategies. It highlights the need for fit-for-purpose study designs and statistical decision-making, especially for pharmaceutical development.
Area of Science:
- Pharmaceutical Science
- Analytical Chemistry
- Biotechnology
Background:
- Method transfer from lab to production is crucial for pharmaceutical development.
- Economic pressures drive method transfers, but official guidance is lacking.
- Existing FDA and ICH documents do not cover method transfer specifics.
Purpose of the Study:
- To provide analysts with a comprehensive overview of analytical method transfer.
- To review scientific literature on transfer study design and sample size.
- To focus on statistical decision-making and risk management in method transfers.
Main Methods:
- Literature review of available documentation on method transfer.
- Analysis of statistical methodologies for decision-making and risk management.
- Review of published examples of pharmaceutical, bio-pharmaceutical, and biological method transfers.
Main Results:
- No official guidance exists for study design, data analysis, or decision procedures in method transfers.
- Experiments and methodologies must be tailored to the specific purpose of the transfer.
- Various strategies and statistical approaches are available for successful method transfer.
Conclusions:
- Analytical method transfer requires careful planning and execution.
- Statistical methodologies and risk management are key for successful transfers.
- Published examples illustrate diverse approaches to pharmaceutical method transfer.
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