Changes in the global marketplace are quickly altering the demands on biopharmaceutical manufacturing facilities. DME can work with you to develop a next-generation biotech facility design that is cost-effective, flexible and responsive to a diversified product line.
Meeting tomorrow’s demands today. We don’t need to tell you that the biopharmaceutical industry is changing quickly. But is your facility keeping up? With the development and expanded application of disruptive technologies such as single-use/disposables, process closure and continuous bioprocessing, facilities need to evolve too. Next-generation biopharm facilities emphasize:
- Flexible multiproduct facilities with quicker changeover
- Expanded use of disposables and single-use technology
- More reliance on closed processing for product segregation
- Increased use of continuous processing, and
- Consolidation of classified manufacturing space.
From now to next-gen. Going the next-gen future facility route likely requires a radical change in your approach to manufacturing. Yet, it can be a wise investment that actually reduces business risk. A facility that can be easily modified or expanded, adaptable for multiple products or changes in process platforms is inherently less risky. That means a more nimble facility; one that can respond to new products, changing regulations and other market developments. What’s more, this flexibility doesn’t have to mean higher cost. Properly designed, next-gen facilities can actually represent a lower initial capital investment and in many cases a lower operating cost center.
What does your future facility look like? You’ll probably see expanded applications for single-use/disposable (SUD) technology; but it doesn’t necessarily mean goodbye to stainless steel (SS). Depending upon your production requirements and product portfolio, large-scale biomanufacturing in SS or hybrid SS/SUD process systems may make sense, but with a future facility spin. More robust manufacturing platforms will be required, and a risk-based facility design approach will be the norm. Expanded use of Process Analytical Technology (PAT) and Quality Risk Management (QRM) tools will improve assessment, control and management of quality risks across the product lifecycle. These are elements of next-generation biotech facility design too, and they are transforming the way that modern biologics manufacturing facilities are operated and maintained.
DME can lead the way. At DME, our team of engineers is deeply experienced in, and focused on, advanced technologies for biomanufacturing. We work step-by-step with clients transitioning to a next-generation biopharm facility, analyzing current processes and recommending a facility design and manufacturing approach that achieves your goals. The result is efficient and compliant production operations that integrate the space program, process equipment, facility segregation, utilities and logistics. We’ll provide the planning and expertise to guide the project, partnering with you every step of the way.