What Is Involved In Bioanalytical Method Transfer For Pharmaceutical Products?

Bioanalytical method transfer is increasingly becoming a crucial aspect of drug discovery and development. An obstacle delaying the analytical method transfer in pharma processes could be very costly, especially with post-transfer failure, as they may delay the projects, costing both money and time to sort out the challenges. It is necessary to view method transfer as a solution to a trouble-free bioanalytical method development rather than a hurdle in analytical method development.

What are the different analytical method transfers in pharma and drug development processes?

The most common method transfer approach is comparative testing. Comparative testing is performed on similar batches of target material against standard samples or batches prepared for testing. Co-validation is another approach for bioanalytical method transfer. Co-validation comprises validation of bioanalytical procedures among laboratories while performing partial or complete validation of the methods.

For bioanalytical method development and validation, the extent of the transferred method and its implementation must have a risk analysis that considers several vital aspects of method transfer. They may include the specifications and complexity of the receiving unit, previous knowledge and experience of the receiving section, and the specification and complexity of the method and the intended product. Bioanalytical method transfer is generally carried out between testing laboratories of two different companies or just a single company with two laboratories or two separate sites.

What to do for a successful bioanalytical method transfer?

Bioanalytical method development and validation cannot follow a one-size fit for all approach in bioanalytical method transfer and companies are increasingly considering tailored solutions for their experiments. Although method transfer is not a protocol with general parameters, some crucial factors are necessary from an ideal practice perspective. It is mandatory that the receiving laboratory is technically capable and has proper compliance status to support and complete the studies in the desired timelines. The receiving laboratory should be able to generate robust data with appropriate sensitivity and complemented with knowledgeable and trained lab staff. The staff should not only be equipped with up-to-date technical expertise but should also stay abreast with the ever-evolving regulatory scenarios.

The receiving laboratory must have appropriate GCP/GLP accreditation, depending on the study type to be performed. The receiving laboratory must have adequate resources, and if the method transferred needs to support regulated bioanalysis, usually the transferred method should already be developed and validated. A validation report and documented analytical procedure are benchmarks for the robust transfer of bioanalytical methods.

The road ahead

It is crucial to consider the fact that if the method is already exploited to generate vast amounts of data in other studies, laboratories should be capable of comparing the data to the procedure when it was used earlier. Moreover, laboratories performing bioanalysis should comprehend the impact accuracy and variability will have on the generated data and then build upon the inferences, allowing users to bank upon for its routine use. In conclusion, a successful method transfer relies on a well-understood and thoroughly documented method that can be precisely followed by the receiving laboratory.