How to Ensure Smooth Technology Transfer - - BioPharm International

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How to Ensure Smooth Technology Transfer


BioPharm International
Volume 21, Issue 3

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
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,
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