Expediting the Technical Transfer of Biopharmaceutical Products - Proper infrastructure ensures equivalent analytical results at all laboratories for a successful simultaneous commercial release from

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Expediting the Technical Transfer of Biopharmaceutical Products
Proper infrastructure ensures equivalent analytical results at all laboratories for a successful simultaneous commercial release from various sites.


BioPharm International


Communication. Direct communication among all parties involved in the technical transfer before and during preparation of the draft protocol document should be encouraged. Prior expertise in the technology transfer process facilitates the inclusion of well-defined responsibilities, organization of the transfer program, and lessening of avoidable protocol amendments. Communication may include both the transfer and receiving laboratories, the technical transfer officer, and the quality units from both sites. Whenever possible, teleconferences should be scheduled (taking into account time differences) to allow for direct discussions to clarify any issues. The transferring laboratory's expertise should be openly disclosed to discuss any questions or expectations by the receiving laboratory during protocol preparation. Sensitivity to different cultural backgrounds and potential language barriers may need to be addressed.

As an example, due to language subtleties, the receiving laboratory may erroneously interpret a procedure described in a method. This situation can be avoided with side-by-side training and clarification of any statements perceived as vague.

Practical Training. Once the technical transfer protocol has been prepared and approved, it is desirable to provide direct training to the receiving laboratory before protocol execution. The complexity of the training for release testing may vary according to the complexity of the analytical methods involved. There are no perfect methods, and often, direct visual demonstration of procedures such as sample preparation, handling, and sample application can avoid erroneous method interpretations arising from language nuances. In addition, training on specialized software for data analysis may be included as needed. Analytical data analysis templates should be prepared ahead of time for the receiving laboratory, as well as accompanying examples of representative data. Simultaneous training of two analysts is preferred, although we have successfully transferred multiple methods to a single analyst. The transferring laboratory must carefully coordinate side-by-side training activities to allow sufficient time for completion of all methods by trainees. Contingency plans for repetition of side-by-side training in case of technical failures are not required, but highly recommended. Our policy requires that all original training records of the receiving laboratory analysts must be documented and retained according to the practices of the transferring laboratory regardless of the documentation practices for training at the receiving laboratory.

Protocol Execution. Once preliminary training is completed, execution of the preapproved technical transfer protocol may take place at the transferring and receiving laboratory sites. Each method will dictate the need for equivalencies in instrumentation between laboratories. Parameters to consider in addition to system suitability include instrument performance tests, lot-to-lot, and interlaboratory variation at the time of data review. In the case of commercial product, the analytical release method needs to be fully validated per ICH guidelines2,3; thus, transfer of commercial release methods must comply with guidelines and be reflected in the transfer protocol document. Samples used for method transfer testing need not be from commercial lots, and may be representative samples. The advantage of using freshly manufactured and released batches as the choice for technical transfer protocol execution obviates the need of retesting at the time of transfer by the transferring laboratory. The transfer training measures the ability of the receiving laboratory to perform the testing from the transfer laboratory within the preset acceptable criteria limits.

Data Analysis. Analytical data should include tabulated values from each laboratory, standard deviations, and coefficients of variance to establish meaningful statistical correlations in interlaboratory or instrument-to-instrument variations, for instance. Free exchange of analytical results should be encouraged to facilitate satisfactory completion of the protocol. If commercial lots are used for analysis, the transferring laboratory may provide the original results from the product release certificate of analysis. The choice of sample lots should be considered carefully to include samples whose analytical values are representative of the entire range of specifications. For example, results in the average range should be used along with lots trending towards high and low ends of the specifications. This practice might be more challenging, given the expected higher analyst variability during initial tests at the time of training, but it will ensure better consistency at the time of true product release. On completion of data analysis, conclusions of the successful completion of transfer should be documented and included in the protocol for final review and approval.

Investigative Procedure Failures. Procedures detailing the handling of laboratory test result failures should be compared between both transfer sites and a common remediation practice procedure should be established and included in the transfer protocol. In the case of simultaneous commercial product release from multiple sites, procedures for handling result discrepancies should be established prior to the initiation of release testing. In the case of biopharmaceutical sample preparation, handling, storage, and stability are critical parameters for correct analytical testing.


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