At INTERPHEX 2017, David M. Marks, founder and president of DME, was part of INTERPHEX Live panel discussion on the topic: The Future of Flexible Manufacturing. David has written on the subject and has spoken at several ISPE events on the theme of flexible manufacturing. In “Biopharmaceutical Facilities:What Kind of Flexibility Do You Need?” he wrote:
Traditional approaches to GMP facility design often tend to focus too early on physical attributes such as square footage or process scale as a function of single-product throughput. This approach neglects the foundational dialog regarding flexibility, proceeding on the assumption that all stakeholders understand and agree on the requirements for the facility. Simply saying that facility flexibility needs to be maximized is inadequate.
Important questions need to be answered to establish the basis of design. Will the facility be used for process development, clinical manufacturing, or commercial production, or for some combination of purposes? Is a phased expansion of capacity planned for the future? What current and future regulatory agencies will the facility have to comply with? Is there uncertainty regarding future manufacturing technologies to be used? Does the manufacturer’s pipeline include products that may require different unit operations or processing at a different scale? Is a shell space or additional utility capacity advisable to handle future process modifications? The answers to these questions, among others, identify what kind of flexibility is most important for a particular facility. This mission should be clearly delineated in the project charter.
We are pleased to make the video of the INTERPHEX Live discussion available here. As you watch the session, you will find out early that flexibility can have multiple “looks” including expansion, scale and quick change over to new products, to name just a few.