Article by Trefor Jones
The failure of a Technology Transfer process will, at best result in delays to product sales and increased costs, and at worst may lead to 483 notices, warning letters, loss of reputation and most importantly an impact on the health of potential recipients of the treatment.
During my observations of Technology Transfer projects, the following reasons rank as my top five reasons for Technology Transfer failure:
Product / process not properly defined.
If the product is not well characterised and the production process not well defined then assumptions usually get made (and you know what they say about assumptions). This can result in “minor” or cosmetic issues (such as tablets the wrong colour being produced) to major quality deviations, batch rejects and 483’s for lack of process control being issued.
Although in general each process step is described in the process definition, there is often a failure to define critical process steps and critical parameters in short – the failure to define the process Design Space. This usually results I unacceptable delays resolving process parameter deviations, unwanted side effects and unanticipated impurities leading to the inability of the product to meet product specifications.
Lack of Experience
By this I am referring to the lack of personnel experience with the manufacture of similar products or type of product. This can lead to gross assumptions being made and an over reliance on process descriptions and SOPs, neither of which are usually detailed enough to allow inexperienced staff to carry out the process (be it the actual manufacturing or performing an analytical method) in the intended manner, or to be able to recognise and flag up anomalies, faults or irregularities in a timely manner if at all. Quite often this will result in out of specification products and significant deviation / CAPA generation activities being required.
Lack of a Technology Transfer Plan
There can be over 75 different processes which have to be performed during a typical technology transfer programme. These processes all have to be planned I properly in sequence and in concert with each other. There is often no pre-constructed Technology Transfer plan, and even if a plan exists, quite often there is a failure to assign specific responsibilities to the tasks within the plan. Making-it-up-as-you-go never works except for the very simplest transfers. Lack of a transfer plan usually leads to confusion, late delivery and often as not, the requirement to repeat tasks that have already been performed.
Use of substitute equipment
It’s very unusual for a receiving site to have exactly the same analytical and production equipment as the donor site, and even if it does, the chances are that one is a later version of the other.
This means that no two pieces of equipment will work exactly the same as each other which can lead to unintentional differences in both processing and testing the product. This is especially true for biologics production systems which can be very sensitive to even slight changes in process or testing conditions.
Sometimes I have even seen one piece of equipment substituted for another one that does the same (almost) as the first – such as membrane filtration units instead of depth filters, or impeller mixers instead of Z-blade mixers – resulting in amazement when the end products are not to the same specification. Of course scaling up of a process quite often falls foul of this type of thinking – a bigger piece of equipment although it looks the same and works in the same way often doesn’t perform in the same way as many people who substituted a larger bioreactor for a smaller one have found out to their cost.
Dedicated Technology Transfer Manager.
It always amazes me how often the task of managing a technology transfer project is given to someone who already has full time role on a secondary basis, on the grounds that it doesn’t need a dedicated manager or specialist. In all but the simplest transfers, it is a false economy to do this – one missed or mis-timed step can lead to significant time-delays and costs.
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