Single-use bioreactor technology is more than a decade old. In that short time, these single-use units have quickly become an established addition to today’s biotechnology manufacturing facility because of the great number of advantages these disposable bioreactors provide. While there many advantages to single-use bioprocessing technology, reusable bioreactors are still the technology of choice for many biotech producers.
Benefits of Single-use Bioreactors
Because it uses a disposable bag instead of a culture vessel, flexibility is one of the big advantages to using single-use bioreactors. Drug manufacturers are increasingly moving towards becoming multi-drug facilities, which must be able to produce several drugs within one facility at minimal time and cost without compromising the quality of each drug. The main bottleneck in such facilities is usually validation of cleaning and line clearance, which ensures no carryover from one batch to the next. Over time, this downtime results in fewer batches.
Reusable bioreactors require expensive and bulky clean-in-place (CIP) or steam-in-place (SIP) installations. The disposable bag of the single-use bioprocessors circumvents the need to use CIP and SIP systems. The disposable bags are usually made of a three-layer plastic foil, with the layers frequently consisting of polyethylene, PVA, PVC, and polypropylene combinations to minimize leakage.
Single-use bioreactors are suitable for cultivating human cells, insect cells and other cell types with relatively low oxygen demands, whereas reusable units have a wider scope of possible uses. While efficient and relatively versatile, there are some drawbacks to single-use bioreactors.
Reusable Bioreactors are Preferred in Some Situations
Scalability is an issue, in that large-scale operations need larger-scale bioreactor bags, which are not always readily available. Single-use units require repetitive purchases, which increases production cost. Fluctuations in the single-use bag market can cause an increase in the variable costs per run.
Single-use bioreactors are easy to move when empty but difficult to move when full; they also have non-advantageous increased pressure and temperature sensitivity. Furthermore, many single-use units have limited liquid transfer capabilities, making them inefficient in greater than 10,000L bioreactor scale processes. Most cannot store hot liquids. Others contain leachable compounds in the linings.
Reusable bioreactors are superior in some ways, especially for dedicated products. Most large-scale facilities have already invested in the ground, installed the tanks, and acquired the necessary cleaning validations to support multiple product use. Reusable bioreactors also present less potential for puncture. Furthermore, single-use units incur greater disposal costs than do reusable units.
Choosing between single-use and reusable bioreactors depends largely on the number of products offered by a facility, access to disposable bioprocessing supplies, room and cleaning costs.
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