Brian Woodrow
A case study described a process to gather, document, and evaluate information for successful analytical method transfer between two laboratories, including protein content, potency/titer, and compendia methods. The key to successful transfer is producing, approving, and training on the plan in advance of transfer activity. This process provides a clear understanding of the scope, issues, resolutions, and resulting data to support transfer between laboratories.
Analytical method transfer is rarely an uneventful process regardless of the product's stage of development. Whether the product is in early phase clinicals or an approved commercial product the planning for an analytical method transfer is critical for achieving a successful outcome. To achieve successful transfer, it is imperative to understand and minimize any differences between the transferring lab and the receiving lab. This discussion will present a case study describing and demonstrating a process to gather, document and evaluate the necessary information to create a successful analytical method transfer for a product release/stability testing panel between two laboratories. For example, a protein content method, a potency/titer method and compendia methods will be discussed during this case study. The key to ensuring successful transfer is to produce, approve and train all parties on the plan in advance of any transfer activity. This process provides a clear understanding of the scope of the transfer plan, any issues and resolutions of issues which occurred during the execution of the plan, and the resulting data to support the transfer between laboratories. This process can be applied to a single analytical method or an entire product testing panel at any stage of development.