The Road to BIO: Day 7
Matthew Kennedy, Process Specialist & Senior Associate, CRB, discusses how FutureFacility™ concepts are helping companies make informed, long-term manufacturing decisions. Watch the full interview.
Generally, companies have products in their pipelines at various stages of clinical development, and they need to understand how their existing manufacturing capacity may or may not align with their projections for those products. To make an informed decision, companies must consider the current competitive environment, evaluate the risk of pipeline attrition and determine whether products have different variations in patient population. CRB understands that investing in manufacturing capacity amid this level of uncertainty is a challenge, and has designed FutureFacility™ concepts to help companies navigate the marketplace, and make long-term investment decisions.
We’ve seen tremendous innovation in biotech over the last decade, which has facilitated a sharp uptick in productivity on the upstream side of cell culture. Of course, changes in the upstream process must be coupled with those downstream, and so the introduction of technologies like multi-column chromatography is necessary to help the downstream efficiency keep pace with upstream. These technologies lead to a reduction in both footprint and cost, and there are tremendous opportunities that lie ahead when these ideas can be organized within a facility design.
Single use technology is no longer in its infancy, but it is still maturing within the industry. This technology can be costly to operate, but when continuous manufacturing is overlaid, the process becomes much more efficient. Over the long term, this can provide a tremendous impact in terms of cost, as companies no longer need to invest in something that goes under- or over-utilized because of uncertainties in the product pipeline. Overlaying these technologies helps to marry manufacturing capacity and cost with product demand.
The FutureFacility™ concept aligns manufacturing capacity with demand. By creating a solution that is scalable and expandable, it can be rapidly deployed and set up in various parts of the world. There are a number of ways in which the facility design itself can be operated to respond to changes in manufacturing demand, or if new products are introduced, it can be dialed up or down in capacity within a continuous closed manufacturing setting.
A FutureFacility™ project requires an infusion of novel thinking about how to deliver a new product. We try to think about the facility as a whole and to organize the manufacturing aspect of it in a way that allows for future expansion and that takes advantage of some of the benefits of those larger facilities. Companies can continue to use vendors that provide single-use technology and do commissioning and insulation qualification while the facility is being constructed, which enables companies to compress the overall timeline and defer the investment until the necessary capacity is determined.
For over 30 years, CRB has specialized in delivering high-quality bioprocess facilities that are safe, reliable, and sustainable. CRB provides services across the entire project lifecycle, from conceptual design through preliminary and detailed design, construction, commissioning, and validation. The company has more than 900 employees across 14 offices and hundreds of project locations around the world. CRB offers a range of services from packaging solutions, fill/finish design, aseptic processing to operations improvement solutions.
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