Wednesday, May 28, 2014

Single-Use Tech: How it Stacks Up in Virus Production

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.

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. 

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

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