This transfer road map consists of good-practice guidelines and comprehensive templates that integrate the concurrent transfer
work streams of drug substance, drug product, analytical methods, and packaging requirements. The key activities for each
of these work streams are aligned with good laboratory practices or current good manufacturing practices to ensure consistent
and controlled manufacturing of a high-quality product. In addition, there are specific activities to address program management,
documentation, and site readiness requirements. The road map is then customized to address health authority guidance based
on filing and launch strategies.
The road map helps to optimize these transfer work streams and activities by:
- Addressing potential manufacturing equipment and processing constraints in the initial process design stages
- Ensuring that only the necessary transfer activities will be executed to avoid interfering with new product launches
- Managing compliance and regulatory activities
- Allocating assets more efficiently to support both ongoing production and transfer activities
- Establishing integrated plans (key activities, dependencies, inputs/outputs, and deliverables) between the sending and receiving
In the absence of such a road map, companies often grapple with technology transfer issues long after development work has
been completed. Consider the example of a large biopharmaceutical organization that so far had treated its technology transfer
haphazardly. As a result, the company had run into many problems, including delays in the launch of new products, suboptimal
product cost structures at launch, unpredictable project timelines, and inconsistent use of resources across projects. Facing
a burgeoning product development pipeline on the one hand and severe capacity constraints on the other, the company's management
made technology transfer its strategic priority.
The effort paid off. After the company implemented an integrated, scalable technology transfer methodology, it achieved significant
improvements in cycle times, process yield, first-time transfer success rates, and production costs. Moreover, it was able
to keep technology transfer projects off the development critical path. This way, materials (e.g., clinical supplies and launch
materials) were always on time for trials and new product launches. Additionally, the company's internal staff became significantly
more efficient: for example, it initiated three new projects without the need for additional hiring.
In addition to a sound strategy and road map, the right transfer organization will help to ensure successful implementation.
This is particularly important as transfer activities expand and become more complex. Managing the growing number of variables
(locations, operational practices, different priorities, varying incentives, etc.) requires a robust governance and organizational
structure. The hallmarks of such an organization include: cross-functional executive governance to facilitate rapid, informed
decision making; clear functional roles and responsibilities; an effective team to drive transfer execution and knowledge
transfer; and relevant performance metrics.
However, in a rush to begin execution, companies often do not take the time to establish the right capabilities up front.
The symptoms of inadequate organizational capabilities include ineffectual decision-making, limited involvement of senior
management, misalignment of transfer expectations, fuzzy roles and responsibilities, poor measures of transfer success, delays
in transfer, and loss of knowledge between sending and receiving sites. Ultimately, these organizational shortfalls cost the
companies dearly in lost revenue due to delays and rework.
Take, for example, the case of a large pharmaceutical company with multiple early-development sites supporting downstream
development. Faced with mounting fiscal pressures, the company needed to increase productivity between its early- and late-stage
development activities. Moreover, the company was experiencing increased development timelines because of delays in downstream
development. This was caused by corporate incentives to accelerate compounds through the early stages of development without
the appropriate level of rigor given to develop robust processes.
The company's existing technology transfer practices were not helping. In fact, they were contributing to poor use of resources,
misalignment of expectations and incentives between sending and receiving groups, and inability to consistently meet the needs
of downstream development. In addition, the processes being transferred were neither easily scalable nor economical for long-term
support, and the process knowledge was poorly documented.