by David M. Marks, P.E., President
Programming GMP facilities has always been a challenging endeavor. Market uncertainties, limited process definition, and stringent regulatory requirements typically complicate the task. Too often, manufacturers end up with facilities that are underutilized or over capacity from day one. McKinsey & Company identifies Rightsizing Capacity and Greater Flexibility as two of the leading trends shaping the landscape of biopharma manufacturing today. These are really two sides of the same coin, as both elements have a direct impact on facility utilization and total cost of goods sold. Generally, facilities that are more flexible tend to be better utilized. But what kind of flexibility is most useful to achieve this utilization? And how can we ensure that future facility designs achieve this flexibility?
Industry Insights on Facility Flexibility
As part of DME Facility Focus, an industry-wide survey of the life sciences industry conducted by DME in partnership with INTERPHEX, we asked industry insiders – those in engineering and operations roles – what aspect of facility flexibility is most valuable. Ranked from most to least valuable, participants responded as follows:
- Ability to produce multiple products with quick changeover
- Ability to easily adapt the facility to new products and manufacturing processes
- Ability to accommodate both large and small volume production requirements
- Ability to easily expand or repurpose manufacturing space
- Ability to convert between clinical manufacturing and commercial production
All of these elements are useful to maximize facility utilization, but overall multiproduct manufacturing with quick changeover is clearly valued the most. This held true even when we broke down responses by job function and affiliation. However, there were some notable differences in response when we looked at the secondary factors:
- Respondents in engineering roles significantly favored the ability to easily expand or repurpose manufacturing space.
- Respondents in manufacturing roles significantly favored the ability to easily adapt the facility to new products and manufacturing processes
- Respondents in R&D roles significantly favored the ability to accommodate both large and small volume production requirements
When you think about it these responses make sense because each survey cohort values the aspect of flexibility that is most useful in their role. It also underscores the importance of making sure that all of your team is all on the same page when engaging in a facility programming effort.
Flexibility by Design
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. What is required is a better understanding of the types of flexibility that manufacturers need, from which we can more accurately develop facility designs tailored to the desired outcome. As applied to right-sizing facility capacity and building in flexibility by design, an in-depth grasp of the manufacturer’s business requirements and specific flexibility needs is essential.
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.
Acknowledging that not all facilities have the same mission, we can also interpret the survey response to indicate the most common type of flexibility required for facilities in our industry – the ability to produce multiple products with quick changeover. Another way of stating this is to say that efficient multiproduct operations is a predominate need in our industry. This will be the leading flexibility goal many new facilities for years to come. To achieve efficient multiproduct operations, the facility program must be driven by well-defined manufacturing processes from day one. The challenge is to be disciplined in working through the prospective manufacturing processes – unit operations, facility traffic, material handling, storage, QC/sampling, product changeover plans, etc. – early in the facility design process when we are often under the gun to hold an aggressive project schedule. It’s not easy, but it’s well worth the effort.
In conclusion, the survey results suggest that the biopharmaceutical industry is best served by focusing on enabling technologies and innovative business models that facilitate the ability to produce multiple products with quick changeover. This should be recognized by suppliers and manufacturers alike. As we, in the biopharma community, strive to improve the quality and affordability of life-altering medications it is worthwhile to refocus from time to time, and to remind ourselves of the importance of building the right kind of flexibility into our future facilities.
The DME Facility Focus survey has provided insight into the minds of industry insiders – those who have their share of war stories from experience with cGMP projects in legacy facilities. Our intent at DME is to continue the dialog. So I’m planning future posts to reveal insights from new survey results every couple months, culminating in an updated and improved Facility Focus program at INTERPHEX next year. For more information about DME Facility Focus, check out www.dmeforlife.com/about-us/facility-focus.
 Otto R; Santagostino A; Schrader U. From Science to Operations – Questions, Choices and Strategies for Success in Biopharma, 2014, 131-134, http://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/from-science-to-operations-questions-choices-and-strategies-for-success-in-biopharma