The concept of throwing away your bioreactor after a single use is quite foreign to me. My professional career grew up on stainless steel bioreactors that sat majestically in these uber-clean processing space in these plants.
But the disposable bioreactor concept appears to be gaining traction.
The idea is this:
You sterilize a plastic bag and you fill it with media. You can mix the contents of the bag. You can control temperature. You have pH and dO2 sensors hooked into a control system that maintains pH and dO2. You have everything that a stainless steel bioreactor has to maintain cell culture. Except when you're done with the operation, you get to throw away the bioreactor, whip out a new sterile bag and repeat.
This also means that you don't have the piping, the valves, the boilers, the steam traps... all the infrastructure that goes into maintaining CIP and SIP systems.
CIP and SIP consumables don't need to be purchased. WFI systems can be smaller. Your Waste Kill isn't taking on all that acid, alkali and rinse solutions.
Staffing overhead to maintain and troubleshoot these systems don't need to be hired. The PLC logic or DCS recipes don't need to be coded. Control loops don't need to be tuned, so your automation engineers aren't as busy.
What about contaminations? Everyone knows from miniferm experiments that tube welding has low associated contamination risks. Everyone know that your failure rates go up the larger your tank. Is it true that success rates are higher with these single-use bioreactors?
But the disposable bioreactor concept appears to be gaining traction.
The idea is this:
You sterilize a plastic bag and you fill it with media. You can mix the contents of the bag. You can control temperature. You have pH and dO2 sensors hooked into a control system that maintains pH and dO2. You have everything that a stainless steel bioreactor has to maintain cell culture. Except when you're done with the operation, you get to throw away the bioreactor, whip out a new sterile bag and repeat.
What's the Advantage?
The most obvious thing is that you don't need to clean-in-place (CIP) or steam-in-place (SIP) the bioreactor... these bags come sterile. This means that you don't have CIP and SIP validation and the associated quality costs.This also means that you don't have the piping, the valves, the boilers, the steam traps... all the infrastructure that goes into maintaining CIP and SIP systems.
CIP and SIP consumables don't need to be purchased. WFI systems can be smaller. Your Waste Kill isn't taking on all that acid, alkali and rinse solutions.
Staffing overhead to maintain and troubleshoot these systems don't need to be hired. The PLC logic or DCS recipes don't need to be coded. Control loops don't need to be tuned, so your automation engineers aren't as busy.
What about contaminations? Everyone knows from miniferm experiments that tube welding has low associated contamination risks. Everyone know that your failure rates go up the larger your tank. Is it true that success rates are higher with these single-use bioreactors?
What Stays The Same?
You're still going to need to execute, so your production organization ought to stay the same. You're still going to need to troubleshoot the process, so your Manufacturing Sciences process support stays the same. You still need scheduling, you still need downstream recovery and purification. All that stays the same.
I Still Have A Few Questions...
- Do Single-Use Bioreactors (SUBs) decrease my plant shutdown times?
- What is the turn-around time (from dirty to prepped) on a SUB?
- What commercial products are manufactured with SUBs?
- At what scale are SUBs proven?
- What is the Total Cost of Ownership of SUBs?
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