Lack of documentation, lack of appropriate personnel involved in the transfer, or shortcuts like forgoing mutual site visits by donor and receiver personnel can result in the recipient being unable to replicate the process or efficiently correct it when it goes awry. As a result, time to market grows longer and additional costs pile up. And for new companies dependent on funding at each development milestone, missed timelines can be deadly.
Even in organizations with years of experience in cGMP manufacturing, technology transfer is often plagued by multiple problems. In a recent survey, we found that technology transfer is far from a core competency in the industry today. Budget and schedule overruns occur far too often. Most companies do not use dedicated teams to execute tech transfer. Moreover, the transfer of process knowledge is often ineffective.For companies that have never transferred a process, the challenge may seem especially daunting. It doesn't have to be. By making the process and analytical transfer package (P&A-TP) the focal point of the effort, you can balance the goal of accomplishing the transfer rapidly with the goal of making as few mistakes as possible. A comprehensive P&A-TP coupled with carefully designed technical transfer protocols (TP) derived from it, can enable a smooth technology transfer of your process.
Technology transfers of course differ in their circumstances, their stringency, and their purposes. For example, the transfer may take place from one site to another within your company, or from your company to an external site like a contract manufacturing organization, or a company that has licensed your product. In both cases, the move could be across borders. Because the creation of the P&A-TP and the protocols requires close cooperation between donor and recipient, an internal transfer would appear to be easier. Large companies, of course, already have a standard internal P&A-TP process in place. But for many early-stage biotechs, no such framework exists. And in creating one, they should be on guard against being lulled into complacency by the fact that the transfer is internal.
A transfer outside the company may require more persistence in securing fully comprehensive information from the external partner. Moreover, because the transfer is external, your organization may inadvertently withhold critical information out of concern for your intellectual property. When the transfer occurs across borders and cultures, such difficulties and concerns may be compounded.
Technology transfers may differ in other ways as well. For example, during Phase 1 or Phase 2 development, the transfer may be undertaken to determine whether the product can be successfully manufactured from a laboratory-scale process to a pilot scale producing cGMP material for the first time. Such an early-stage transfer is relatively less demanding and time-consuming than a transfer in Phase 3 for full-scale cGMP production and commercialization, with far more stringent requirements for compliance and process validation. In either case, however, a comprehensive P&A-TP can make all the difference between an efficient transfer and a process bogged down in rework, inadequate protocols, and repeated calls from the recipient for more information.
Depending on the circumstances, the specific responsibilities involved in creating the P&A-TP and the protocols may be divided in a number of ways. Generally, however, when there is no pre-existing P&A-TP, both the donor and the recipient collaborate closely on creating one. For example, the donor may create a preliminary P&A-TP based on the equipment, scale, and other operating conditions of the process at its site. The recipient may then edit the donor's preliminary P&A-TP based on conditions at the recipient site and return the document to the donor, along with requests for additional information, if needed. Once both parties have agreed on the final P&A-TP, the transfer protocols are created either by the donor or the recipient—again, depending on the particular circumstances of the transfer.