Step-by-Step Guide to Troubleshoot ‘Method Transfer’ Challenges and Things You Did Not Know

Analytical method development and validation are among the most critical parts of drug discovery and development. Majorly, all those products that are clinically successful, analytical method transfer becomes a necessity. This is a crucial process developed for verifying that a given analytical laboratory is capable of performing analytical method transfers aimed at resolving their intended use. 

While performing analytical method transfer, it becomes a necessity to base the analytical method transfer approach on the drug development stage at which it is being applied. The analytical method transfer strategy should be affixed following the nature of the analyte, its validation status, the intended pharmaceutical product, and the overall analytical experience of the laboratories involved in the transfer. 

Method type, experimental design, and data analysis should be defined according to each stage of analysis. This is done to comply with regulatory expectations. 

Essential elements of analytical method transfer

Comparative testing

Comparative testing is a generalized analytical method transfer procedure where both laboratories are involved. Here, the same sample is subjected to analytical testing at both the originating and receiving laboratories. The results obtained at both places are then compared with each other. The entire comparative testing is accomplished by a pre-approved testing protocol defined by pre-approved testing parameters. Occasionally, a comparative testing approach can be clubbed with other post-approval analytical testing parameters, which involve other contract laboratories and additional manufacturing sites. Usually, comparative testing is reserved for later stages of complex analytical method transfers. 

Co-validation

The co-validation process is an alternative to the traditional comparative mode of testing. Here, the receiving analytical laboratory is involved in the method transfer right from the validation protocol. As soon as the method transfer process is accomplished, the principal analyst involved in the whole scenario qualifies the analytical method for the final release testing. This validation process requires the receiving laboratory to identify the intermediate precision validation parameters for evaluation in conjunction with the experimental design. 

Waivers for analytical method transfer

In analytical testing, you may come across certain instances where the formal analytical method may not be applicable or essentially required. These include – 

• If the receiving laboratory is always involved in product testing and is quite familiar with the analytical method being employed in the testing

• When the receiving laboratory is already familiar with the method or procedure for testing a comparable dosage form of the drug candidate intended to be tested.

• If the analytical method is already available in the market and is being widely used

• When an existing analytical testing method has been wholly or slightly modified; however, no effect is produced on its validation status.

Final Execution of the Analytical Method Transfer

Before executing the final analytical method transfer, the clinical team needs to evaluate the feasibility of the work undertaken and ensure that all the paperwork has been accomplished. Any gap analysis, if present, should be thoroughly worked out; a solid foundation for the analytical method transfer should be established, and the testing window of both laboratories should be controlled and well-regulated.

10 Interesting things You did not know About method transfer 

Method transfer is a crucial process in various scientific and technical fields, such as chemistry, pharmaceuticals, and analytical testing. Here are 10 interesting things you may not know about method transfer:

1. Definition of Method Transfer:
   • Fact: Method transfer involves the movement of an analytical method from one laboratory or location to another. It ensures that the method is performed consistently and reliably, regardless of the testing environment.
2. International Guidelines:
   • Fact: Various international organizations, such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), provide guidelines and recommendations for method transfer in the pharmaceutical industry.
3. Parameters for Successful Transfer:
   • Fact: Successful method transfer depends on several factors, including equipment compatibility, analyst proficiency, reagent consistency, and adherence to standard operating procedures (SOPs).
4. Validation of Analytical Methods:
   • Fact: Method transfer is closely related to method validation. While method validation confirms the performance of an analytical method in a specific laboratory, method transfer ensures that the validated method can be reliably replicated in another laboratory.
5. Risk Assessment:
   • Fact: Conducting a risk assessment is a critical step in method transfer. Identifying potential risks, such as differences in equipment or environmental conditions, allows for proactive mitigation strategies.
6. Instrument Calibration:
   • Fact: Ensuring that instruments are calibrated and validated in both the sending and receiving laboratories is essential for successful method transfer. Consistent instrument performance is crucial for accurate and reproducible results.
7. Documentation Importance:
   • Fact: Thorough documentation is a key aspect of method transfer. Detailed records of the transfer process, including any deviations, adjustments, or corrective actions, provide a transparent and traceable history.
8. Communication Between Laboratories:
   • Fact: Effective communication between the sending and receiving laboratories is vital. Clear communication ensures that both parties understand the intricacies of the method and any specific requirements for successful transfer.
9. Flexibility in Methods:
   • Fact: While method transfer aims for consistency, there may be cases where slight adjustments are necessary to accommodate differences in equipment, reagents, or environmental conditions between laboratories.
10. Regulatory Compliance:
    • Fact: Method transfer is subject to regulatory scrutiny, especially in industries like pharmaceuticals. Following established guidelines and maintaining regulatory compliance is crucial to ensuring the reliability and integrity of the transferred method.

Method transfer is a dynamic process that requires careful planning, execution, and documentation. It plays a crucial role in maintaining the reliability and consistency of analytical methods across different laboratories and locations.