3. Clear project definition and scope
To get buy-in, it is critical to clearly convey the parameters of QbD initiatives by breaking down the big picture into workable
goals and objectives—ensuring you do not overreach in terms of the scope. Implementing QbD in stages can help get the green
light turned on. An implementation plan that starts with a quick and clear return on the project cost can be beneficial to
demonstrating return on investment (ROI) and getting approval for longer-term implementation projects.
Figure 3. Which of the following organizations are involved, or will be involved, in your QbD initiative?
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It's also important to demonstrate the value and benefits of having teams collaborate on QbD initiatives. Process development,
manufacturing, and quality assurance all need to work together. There was good news in the Aegis/AMR survey regarding which
groups were involved at those companies that were planning or already implementing QbD initiatives (Figure 3).4 Having these groups work together requires the right technology that enables access to data in the right context for various
users.
4. Near-term return to the bottom-line
The fact that most US companies typically make decisions based on near-term results presents a challenge. In the case of
return to the bottom-line, QbD implementation teams really need to take a mid- to long-term view rather than promote unrealistic
expectations about near-term returns.
As mentioned above, structuring an implementation program to show an early return based on a limited scope can build confidence
in the potential for larger, longer-term benefits. For example, choose a new process with a high degree of process variability
for a pilot implementation to show time saved by removing variability from the process. Showing how a reduction of as little
as three weeks of process development time saves $20 million of out-of-pocket and opportunity costs is, for example, a very
compelling ROI.
Looking specifically at opportunity cost, the numbers grow large very quickly. The total revenue for the biotech industry
in 2002 was $42.6 billion, derived from sales of the 130 biotherapeutic drugs on the market at that time.6 The estimated revenue potential of an average biotech drug can thus be calculated as $328 million per year. This converts
to an opportunity cost of roughly $1.3 million per day for each day of the working week that a new biotherapeutic is in process
development rather than on the market. Taking the midpoint of the range of process development project resource hours (406,000
hours) and the midpoint of the time such projects take (42.5 months), and using a fully burdened technical personnel cost
of $225 per hour, we can calculate the burn rate of a biotherapeutic development project at roughly $107,000 per day for each
day of the working week. So, the full cost to a biopharmaceutical company for each working day that a new therapeutic is in
process development rather than on the market is on the order of $1.4 million per day.
5. Significant impact on corporate goals
As mentioned previously, corporate goals need to be appropriately aligned with the objectives of QbD in terms of 1) operating
costs, 2) the public good, and 3) remaining competitive. If company goals follow these themes, QbD initiatives can definitely
help achieve those goals over the long-term.
Some of the specific, potential longer-term business benefits that can be related to the bottom line and corporate goals include:
- reduced batch failures, final product testing, and batch release costs
- lower operating costs from fewer failures and deviation investigations
- increased predictability of manufacturing output and quality
- reduced inventory costs from raw material, work-in-progress, and finished product
- faster technology transfer between development and manufacturing
- faster regulatory approval of new product applications and process changes
- fewer, shorter, and less costly regulatory inspections.
The last benefit should be driven home when the FDA completes its aforementioned study assessing the value of QbD information
in applications.
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