Which Characteristics Help Distinguish Quality of Your Analytical Assay Method Transfer?
In pharmaceutical companies, a separate department is dedicated to the development of bioanalytical assays and method validation. Some companies also outsource the bioanalytical method development and validation for their drug development process. In both scenarios, the bioanalytical assay development developed by the bioanalytical department or method development services must be translated to the clinical research unit to implement the bioanalytical assay development in drug developmental studies. This transfer of the method procedures and all related documents comes under the analytical method transfer in pharma protocol. This whole protocol is extremely important as it enables the pharmaceutical companies to execute the bioanalytical methods properly and reliably during drug development. Any discrepancy during the transfer protocol could affect the intended use of the bioanalytical assay and thus hamper the drug development process. The analytical method transfer in pharma report also needs to be submitted to regulatory authorities while seeking approval for the new drug.
Analytical method transfer in pharma
As per United States Pharmacopeia (USP), analytical method transfer in pharma is a documented process to transfer a developed and validated bioanalytical method between a transferring laboratory and a receiving laboratory. During the transfer, it is ensured that the receiving laboratory has all the procedural knowledge and ability to perform the assay for its intended use. It is assumed that the receiving laboratory can perform the assay with the same level of sensitivity and precision as the developing laboratory.
Both the laboratories have different sets of responsibilities during a transfer protocol and must follow them stringently to make the transfer successful.
Responsibilities of transferring laboratory:
- To prepare a transfer package that confirms: a) method is written as performed; b) validation is done as per current guidelines; c) documentation of method performance and related history.
- To provide all the documentation related to development, procedures, validation, and risk assessment.
- To provide information related to specific equipment and configuration and about laboratory environmental conditions.
- To supply all related reference and test materials.
- To prepare and approve transfer protocol and transfer report.
- To perform co-validation of the method.
- To assist the receiving laboratory during the investigation and approve the outcome.
- To lend post-transfer support (if required)
Responsibilities of receiving laboratory:
- To review all the documentation received from the transferring laboratory.
- To check the availability of all the necessary equipment.
- To properly store and use the reference and test materials.
- To review, comment, and approve transfer protocol and reports.
- To generate, evaluate, and tabulate laboratory results and check any deviations and non-conforming results.
- To demonstrate the ability to perform the procedure as intended in the future as well.
In some instances, the transferring laboratory also provides training to the receiving laboratory personnel. This is important to ensure that the bioanalytical assay development will be executed as expected by the receiving laboratory to generate reproducible results.
Good understanding and communication between the two laboratories are essential for a successful method transfer. This helps in mitigating any misconception that would arise during the transfer procedure. The exchange of every minute detail is very essential for complicated bioanalytical methods. It enables the receiving laboratory to execute the assay without even having significant prior knowledge.
Analytical method transfer in pharma is as crucial as the complete process of drug development. Method transfer failure would cost delays in the program and can disturb the timeline of drug development. Both the transferring and receiving laboratories are equally responsible for a successful transfer of the bioanalytical method. There are no stringent rules and regulations for a method transfer protocol, but a strong working relationship, good communication, understanding, and proper documentation can make the process successful.