Wednesday, June 2, 2021 by
Speed to market is critical for bio manufacturers. 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?
Benefits of using single-use technology
Research and Development
- Components are inexpensive while durable enough for multiple uses.
- No need for cleaning or regeneration of components which decreases turnaround times.
- Using pre-made disposable manifolds rather than building a flow path for each different processing run gives more consistent results.
- Separation of capital and disposable equipment budgets allows more time to make the final decision on single-use configuration.
- Changing out configured single-use components often does not require modification to capital equipment.
- Single-use components can be supplied pre-sterilized and ready to use.
- Single-use technology can provide increased capacity as needed without requiring a second piece of equipment.
Benefits of consistency
Research and Development
- Materials are pre-qualified at the R & D stage and approved for use in the application.
- Vendors are pre-qualified, audited and already in the supply chain.
- Operator training time is reduced and user confidence with technology is increased.
- Using scaleable automation solutions and single-use components increases the likelihood that control parameters developed on small scale system are available on a larger system.
- Terminology is consistent between R & D and manufacturing.
- Awareness of potential pitfalls in the large-scale process means future manufacturing problems can be prevented.
- All steps can be performed aseptically so a cleaner process will be developed.
- All stages of the process can be developed and perfected in conditions that do not require overhead of special facilities and areas that require constant maintenance.
Want to learn more?
At Parker, we specialize in automating and controlling single-use processes. By integrating sensor and automating technology into a process, parameters can be controlled more effectively, ensuring the quality of the final product from process development to GMP manufacturing. www.parker.com/dhsingleuse
Check out our infographic on Bridging the Gap in Automated Single-Use Technology Between R&D and Manufacturing.
Learn more at our website about the many solutions Parker provides for bioprocessing and biopharmaceutical manufacturers.
Defining Our Unique Contribution to the World
5 Benefits of Single-Use Technology vs Stainless Steel
Early Adoption Single-Use Technology Can Ensure Successful Process Scale-Up
Overcoming Barriers to Single-Use Implementation
Automated Single-Use Technology and Its Impact on Quality
How Automation Takes Single-Use Technology to the Next Level