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.
Start as you mean to go on
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:
- 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.
- User confidence with the technology is increased.
- Using scalable automation solution and single-use components increases the likelihood that control parameters developed on a smaller scale system are available on a larger system.
And, if you use single-use technology during R&D you can also benefit from:
- Decreased turnaround times - as components don't require cleaning or regeneration.
- More consistent results - from using pre-made disposable manifolds, rather than building a flow path for each different processing run.
However, there are a few common pitfalls to avoid, which include making incorrect assumptions regarding how processes will behave at larger scale.
Ensuring successful scale-up in single-use bioprocessing webinar
Parker Bioscience Filtration is delivering a webinar on November 12th, 2019 which will help biopharmaceutical manufacturers build a strategy for effective scale-up of filtration and single-use processes that will 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 will explain how to conduct a small-scale filtration trial using an automated single-use system at laboratory scale and examine the advantages this provides.
The webinar will also further explore the benefits of single-use technology in both R&D and manufacturing, and consider 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.