PA Consulting Group's client had outsourced the majority of their process development and early stage clinical manufacturing activities.
The company believed they needed to develop a level of internal capability to effectively deal with scheduling challenges, IP control, technology transfer and life cycle management. The company was proposing to invest $33-39MM to build a process development centre to develop drug substance/product for small molecules and biologics.
Many options were considered over three years, but could not be agreed on to develop a sound business case for the management team.
agreement on the capabilities and functions to be housed in the facility to manage knowledge internally and with vendors across the portfolio and pipeline
development of a sound business case that provided best fit with the space plan, maturity/evolution of the company and the projected pipeline
consensus from a diverse group of stakeholders not used to working with one another to generate a proposal for the management team with a level of detail not previously achieved.
PA provided a business case that contained a consistent data-set, an understanding of the risks and alternatives and a proposal that makes sense given the client constraints. The proposal was approved by the management team and a site study was initiated.
To find out more about how PA can help you with process development, please contact us now.