Single-use bioreactors are bioreactors that utilize a disposable bag in place of a glass or stainless steel culture vessel. For cell harvest, media and buffer preparation, filtration, purification, and viral inactivation, pharmaceutical companies use it widely.
The introduction of large-scale single-use bioreactors, rising demand from pharma companies, CROs, and CDMOs, the expanding biologics market, rising biopharmaceutical R&D, and the advantages of single-use bioreactors are some of the technological advancements that are propelling the global single-use bioreactors market.
Due to their Ability to Enhance Flexibility, Reduce Investment & Limit Operational Costs, Single-use Bioreactors Have Become Established in Modern Biopharmaceutical Processes
One of the main advantages of single-use bioreactors is their increased flexibility. There is a growing trend towards multi-drug facilities, which warrants the production of different drugs using the same facility with minimum time & cost and top-notch quality. Line clearance and cleaning validation in such circumstances are key manufacturing challenges to guarantee there is no carryover from previous batches. Downtime limits the number of batches produced in a given period.
Single-use bioreactors significantly lessen the amount of time required to get the bioreactor prepared for the subsequent batch. A line changeover with a stainless-steel bioreactor can take ~6 to 10 hours and three weeks for a full product changeover while by using single-use bioreactors it is likely to take 2 hours for line changeover. If the manufacturing line is composed of all single-use components such as bags, filters, and connectors, the total time for product changeover can be 48 hours. Single-use bioreactors may cut downtime from two to three weeks to just 48 hours, which can have a big influence on a company’s output.
Some of the other key advantages of using single-use bioreactors are:
- Elimination of validation issues as no cleaning process is required
- Lowers the risk of cross-contamination
- Reduces operating costs and capital investments (including space, labor requirements, and utilities)
- Single-use bags are scalable and can be adjusted to different volumes
- Simple installation
Potential Time Savings for Highly Trained Personnel Another Key Benefit of Single-use Bioreactors
Normally, drug development research, process development, and scale-up activities are performed by highly qualified and trained personnel. These individuals are involved in all phases of a study from early-stage research through to benchtop manufacturing. Before each trial batch is taken, stainless steel or glass benchtop bioreactors’ individual components must be cleaned, put together, tested for leaks, sterilised, and cooled. However, the use of single-use bioreactors almost eliminates these steps, which allows scientists more time to focus on their developmental studies.
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Competitive Landscape Analysis of Single-use Bioreactors Market
Some of the key players operating in the global single-use bioreactors market are Sartorius Stedim Biotech, Thermo Fisher Scientific, Danaher Corporation, and Merck KGaA.
Other Players Operating in the Single-use Bioreactors Market are (Indicative List):
- Celltainer Biotech BV
- Distek Inc.
- G&G Technologies Inc.
- GPC Bio, among others
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