Speed to market is critical for biomanufacturers. The faster a process can be scaled-up, the faster a return on investment on drug development costs can be realized. With a strong trend towards the use of single-use technologies (SUT) in bioprocessing, what strategies can be implemented during research and development (R & D) to ensure successful scale-up to commercial manufacturing?
When developing new drugs, biotech companies need to focus on the end goal, which is ultimately a validated, approved commercial manufacturing process. Ideally the supply chain is locked down and the procedures are in place to repeatedly produce a product safely.
In a stainless steel processing facility it may be difficult or impossible to make more material with the same equipment when market success leads to the need for additional capacity or facility throughput. A new facility may need to be built just to accommodate the additional demand, which could lead to shortages.
Mobile, single-use and completely contained processing units or systems with closed flowpaths, on the other hand, take up less permanent space and can be set up very quickly.
So what mind set must be adopted to make the transition from one to the other as seamless as possible?
First of all, biotech companies shouldn't wait to adopt single-use automated technology at the pilot level as scale-up issues may arise at the R & D stage. In addition, they should make sure that the materials used in R & D are the same technology that can be used aseptically with automated technology at pilot and process scales.
Find out more about successfully scaling-up single-use bioprocesses in the Scale-Up section of our Bioprocessing Knowledge and Resource Hub.
Successful scale-up can be ensured by utilizing the same automated single-use equipment and strategies in R & D through to manufacturing scale and relying on the expertise of scale-up specialists. Using this strategy, a significant reduction of rework and inefficiencies can be expected in processes that would otherwise be extremely difficult to change once approved.
Click on the infographic for a summary of the benefits of using a consistent approach to automated SUT at R & D and manufacturing scales.
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This post was contributed by Donald Beers, Engineering Supervisor (Single-Use Technology) at Parker domnick hunter Process Filtration, USA
At Parker domnick hunter, we specialize in automating and controlling single-use processes. By integrating sensor and automation technology into a process, a manufacturer can control the fluid flow more effectively, ensuring the quality of the final product from process development to GMP manufacturing
For additional information, please contact Parker domnick hunter Process Filtration: 877 784 2234 (North America Toll Free) +1 805 604 3400 (North America) +44 (0)191 410 5121 242 (Rest of World), firstname.lastname@example.org, www.parker.com/dhsingleuse
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