Manufacturing: BioPharmaceutical Operations Roadmap 2007 - FutureBio 2016 is developing a roadmap to help the biopharm industry achieve operational excellence. - BioPharm International


Manufacturing: BioPharmaceutical Operations Roadmap 2007
FutureBio 2016 is developing a roadmap to help the biopharm industry achieve operational excellence.

BioPharm International
Volume 20, Issue 4


Table 1. Executives identified 22 gaps that need to be closed in order for the biopharmaceutical industry to improve its operational performance.
The most frequently cited goal was the need, both competitively and operationally, to more rapidly move product from the laboratory to commercialization. The major challenges described were scale-up issues resulting in unnecessarily long development times and a large number of deviations in the commercial facility. Overcoming these challenges will produce a desired state that has the largest overall impact on industry's competitiveness. This state is also the most difficult to achieve because of the cultural and operational complexities of development organizations and processes.


The biopharmaceutical industry, in its current form, is unique because of the lifecycle of its products. In other industries, new product versions or generations appear frequently, allowing lessons learned from previous models to be incorporated into new ones. In biopharmaceuticals, on the other hand, companies are still manufacturing products that were approved decades ago. As a result, it is necessary to make regular process changes to adapt to current business conditions. Participants concurred that the industry needs a quicker and less disruptive way to continuously make value-added changes to processes without challenging the need for the change in the first place.

Although major process changes, like eliminating a step or using a significantly different piece of equipment, require FDA filing, many minor modifications do not. Examples include adjusting temperatures and mixing times, or using a new raw material if a vendor stops making the old one. The only requirement in these cases is that equivalence be demonstrated.


The biotechnology industry is riddled with uncertainty. Pipeline products are not assured success in the clinic, market forecasts can be significantly off, and in-licensed or in-sourced products can appear without much forewarning. To prepare for these contingencies, companies need facilities that are flexible and adaptable to business changes.


Within the consortium, there was consensus that the industry should make driving down costs a priority for two key reasons. First, from an industry perspective, companies must be able to provide therapies in a more cost-effective way because of external pressures from government regulators and health care providers. Second, when corporations free up money from operations, it can be applied to building the pipeline and bringing new therapies to market.


The industry has been focused on better overall performance for several years; a key measure being the ability to move product through the supply chain quickly and with high quality. Companies still struggle with minimizing cycle times, primarily because of quality issues throughout the production process. Activities that focus on reducing process variability and improving the processes themselves need to be developed.


The group then worked to identify the key gaps that needed to be closed to reach the desired states. Many of the identified operational gaps apply to more than one of the desired states and were repeated many times during the discussions. The 22 key gaps in Table 1 are organized as follows:

Industry Gaps: the identified operational gaps within most companies in the industry.

Impact: the estimated impact of closing the gap on a specific desired state.

Difficulty: the difficulty of closing this gap, which is affected by internal and external stakeholders and technological advancements.

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