Siddharth J. Advant, PhD
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At some time in a biopharmaceutical product's journey to market, the process by which it is manufactured must be transferred
from one site to another. The reasons for the transfer can vary depending on the type and size of the company. But no matter
where the process goes or why, one thing is certain. Unless the donor and receiver sites have effective and comprehensive
technology transfer capabilities in place, the move will be subject every step of the way to Murphy's Law: whatever can go
wrong, will go wrong.
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.
DIFFERING TRANSFERS
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.
