Whether you are running a process in a 30,000 L bioreactor in fed-batch mode, a 200 L continuous process, or have scaled-out (rather than up), you will start at small scale and look to increase the volume - scale-up - to some degree.
However, we are recognizing that some biotech companies aren't adopting single-use automated technology until the process reaches pilot scale.
This can reduce the likelihood of a successful outcome or the speed of the development process, as process rework may need to be managed further along the manufacturing development process.
In some cases, changes to inefficient processes may be more difficult to implement, especially if they have already been approved.
The adage "start with the end in mind" has never been more relevant.
For scale-up to be successful, we recommend using the same automated single-use equipment, strategies and materials from the R&D stage through to manufacturing scale. That way, speed to market can be optimized through simplified technology transfer of optimal process. You will also avoid unexpected rework that may come about due to material compatibility or availability issues.
Speed to market is of critical importance, both from a return on investment point of view, but also with the benefits to patients in mind.
Having single-use automated technology in place at the R&D stage can make the move into the manufacturing stage more efficient.
The benefits include:
And, if you use single-use technology during R&D you can also benefit from:
However, there are a few common pitfalls to avoid, which include making incorrect assumptions regarding how processes will behave at larger scale.
Parker Bioscience Filtration's recent webinar offered advice to biopharmaceutical manufacturers on building a strategy for effective scale-up of filtration and single-use processes. These strategies can help facilitate technology transfer, in order to avoid delays in commercialization caused by inconsistent scale-up of a single-use process between R&D and manufacturing.
It explained how to conduct a small-scale filtration trial using an automated single-use system at laboratory scale and examine the advantages this provides.
The further explored the benefits of single-use technology in both R&D and manufacturing, and considered how to ensure successful implementation of single-use automation from laboratory scale through to large-scale production.
This post was contributed by David Heaney, market development manager (life sciences), Parker Bioscience Filtration, United Kingdom.
Parker Bioscience Filtration specializes in automating and controlling single-use bioprocesses. By integrating sensory and automation technology into a process, a manufacturer can control the fluid more effectively, ensuring the quality of the final product. Visit www.parker.com/bioscience to find out more.