This post was contributed by @MikeMadarasz of the Institute of International Research
Over the last ten years, single-use bioreactors have been
gaining traction in biopharmaceutical manufacturing by answering some of the
key challenges in the industry. We can
expect manufacturers to look to this technology to answer key questions in
vaccine production, especially with the need for animal vaccines reportedly expected to
increase. HIPRA, an animal health company
focused on biologic products for poultry, swine and dogs among other things,
had some recent experience working with single-use bioreactors (SUBs). They outlined some of the major implications
in implementing single-use bioreactors and how they stack up against multiuse
bioreactors (MUBs) in a recent study.
Implementation
According to the study, the first thing that should be taken
into account when considering a single-use system is whether or not you’re
changing from multiuse technology or implementing a single-use system
initially. SUBs tend to deviate from
conventional design, so converting from MUBs requires some adjustment on behalf
of the manufacturers. On the other hand,
when beginning directly with SUBs, it becomes much easier to start small and
scale-up.
Set up time
SUB installation is much more efficient than the multiuse
variety requiring only electrical, power, water and gas supplies. In addition, the sterilization and cleaning
efforts are also greatly reduced. The
report cites this as saving HIPRA about two months of set up time.
Handling
The fashion in which SUBs and MUBs are handled also deviates. SUBs tend to require more manual handling
than MUBs, where many of the sterilization processes are automated. To prevent some of the manual errors, many
single-use bioreactors utilize a system of interchangeable tubes that must be
welded together. That said, the report
recommends changing out “nonweldable” tubing for the variety that’s able to be
welded in order to eliminate those errors.
Quality of Process
Due to the nature of these processes and the fact that they
deal with many viruses, efficiency is not the only thing that needs attention. Safety is certainly a concern as well. How can you properly mitigate biosafety
risks? What can be done to uphold bag
integrity? Is the vendor offering the
necessary training? These are some of
the considerations that must be taken into account in both processes.
You can get the full study, Comparing Multiuse and Single-Use Bioreactors for Virus Production, here.
We’ve got more on the latest in Single-Use technology. Check out Single Use for BiopharmaceuticalManufacturing, June 9-10, Boston, MA.
You can download the agenda here.
SAVE 20%* to attend this meeting. Register here and use code XB14187BLOG.
Join us on LinkedIn
Follow us on Twitter
*Off the standard
rate. New registrants only.
|
Share this article with your social network, just click below to share now!
|
|
|
