Marc Puich

A true visionary leadership is required to drive the progress of operational excellence programs in biopharmaceutical organizations

Scale-up issues leading to long development times and deviations in the commercial facility is a critical challenge.

All contributors to the process should have a clear understanding of their capacity and see their work activities as a priority, regardless of where they fall on the critical path.

Recently, 22 vice presidents of biopharmaceutical operations met in Boston to develop the first operational roadmap for their industry. This special executive-level consortium was organized to discuss two key questions.

Better supplier management can begin in parallel to production-related improvements.

The overhead expense that comes along with each new enterprise application adds up quickly, and can be somewhat invisible to owners of the system.

. . . Popular consortium meetings have focused on successful use of tools to drive improvement in cycle time reduction, deviation reduction, and improved production efficiency.

As with any partnership, working with a CMO can be complex. The level of trust and cooperation between both organizations needs to be extremely high.

The concept is not new. Companies comparing performance and practices and then mutually identifying the best solutions to common operational challenges has been a part of business for years. What is different is that this is happening in the biopharmaceutical industry, which, until recently, has been primarily focused on filling the pipeline and on improving the manufacturing processes themselves. This focus was not misguided- the biggest challenge facing biopharmaceutical companies until the last five years was convincing everyone that they were legitimate players that can develop and supply therapeutics consistently, and not isolated success stories.

As biotechnology organizations have successfully launched new products, the challenges of producing adequate quantities have grown. Many companies are now dealing with multiproduct manufacturing facilities and pushing the limits of their capabilities. One result of this complexity is a loss of production capacity due to inefficiencies.