THE TRANSFER PROTOCOLS
With the P&A-TP in hand, the technical transfer protocols (TP), designed to guide the implementation of process as it is to
be performed, can be created either by the donor, the receiver, or both. The TP includes protocols for the process to be transferred
and protocols for the analytical methods to be transferred. The process protocols describe the acceptable operating limits
of the process and equipment that, if achieved, enable the product to meet its specified quality characteristics. The analytical
protocols ensure that the relevant analytical attributes are evaluated and met during and after the manufacturing of the product.
Figure 1. Transfer protocol pathways
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Typically, the experiments conducted during transfer runs, especially for process transfer, are performed in the process development
laboratories of the receiving site at a reduced scale, taking into consideration the factors critical for the scale-up of
the process. This approach is common when transferring processes for the manufacture of Phase 1 or 2 material. However, for
processes that are being transferred to generate Phase 3 and commercial material, the transfer runs are typically carried
out at-scale, with resulting process and analytical data being included in appropriate comparability reports.
If, as sometimes happens in large companies, identical equipment is in place at both the donor and receiver sites and there
is no question of scale-up, the process and analytical protocols will remain fundamentally unchanged, as Figure 1 depicts.
If, however, scale-up or commercialization is the goal, or the equipment at the two sites differs, the process protocols and
the analytical protocols must be altered to ensure that the process yields the same product and the analytics yield the same
outcomes as occurred at the donor site, as Figure 1 also shows. Further, it sometimes happens that the donor believes that
the process can be reproduced at the receiver site, but the receiver is unable to do so. In that case, the process must also
be altered.
In creating the process and analytical transfer package and deriving carefully designed technical transfer protocols from
it, you move with all deliberate speed toward your goal—the acceptance of the process at the receiver site and, ultimately,
the market.
Siddharth J. Advant, PhD, is a principal at Tunnell Consulting, King of Prussia, PA 858.784.0040, advant@tunnellconsulting.com
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