Scale-Up and Technology Transfer
Meeting product demands in the life science industry
In Pharma manufacturing, transferring a process from location A to location B or company A to company B (e.g., to a CMO) is a natural result of scale-up, scale down, and the process lifecycle. The transfer must be done right to meet regulatory requirements in New Drug Applications (NDAs) or Investigational New Drug (IND) applications. From a business perspective, any delays in the transfer project could cost millions of dollars, so it must be done right the first time.
Many transfer projects fail because they lack a defined structure and detailed plan. The projects rely on batch records as the main sources of process information, but more thorough tools are needed to ensure a smooth transfer.
Kymanox utilizes its proven Technology Transfer Toolkit to help companies manage their transfer projects. Kymanox’s Technology Transfer SOP defines the Technology Transfer process to ensure that transfers are successful on the first attempt. Detailed process description tools are used to collect key process information in an organized, accessible manner. Process Transfer Master Plans, Method Transfer Plans, and Validation Master Plans serve to define the exact needs and requirements for the process to be successful.
This strategy can be seen as adding more documentation and procedures to an already document-heavy industry. However, spending the time to plan the transfer and effectively communicate that plan to all applicable stakeholders and working groups will lead to better business results down the line. The project will be successful on the first try – without delays and repeated efforts that can double or triple the cost of the project. In addition, a well-defined process will make process optimization and continued process verification more efficient as the product lifecycle enters into commercial manufacturing after the successful completion of the tech transfer.