Single-use bioreactors are bioreactors that use the disposable bag as a substitute for a culture vessel made of stainless steel or glass. It is widely used by pharmaceutical companies for cell harvesting, media & buffer preparation, filtration, purification, and virus inactivation.
Due to their Ability to Enhance Flexibility, Reduce Investment & Limit Operational Costs, Single-use Bioreactors Have Become Established in Modern Biopharmaceutical Processes.
Enhanced flexibility is one of the biggest benefits of single-use bioreactors. 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. In such scenarios, one of the key manufacturing challenges is line clearance and validation of cleaning to ensure there is no carry-over from earlier batches. Downtime limits the number of batches produced in a given period.
Single-use bioreactors significantly reduce the time spent preparing the bioreactor 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 possess the capability to reduce downtime from two to three weeks to 48 hours, which in turn can significantly impact a company’s output.
Some of the major advantages are as follows:
- 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
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“The uptake of single-use bioreactors is mainly driven by the activity of the different regions regarding the development of new disease treatments and biosimilars. In addition, existing production capacity comes into play and company strategies regarding the manufacture of clinical material. As the USA is indeed leading in the field of developing innovative treatments, we see a strong uptake of single-use bioreactors, but Europe and Asia are not far behind.”
– CEO, Leading Manufacturer of Single-use Bioreactors, United States
Competitive Landscape Analysis: 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 Prominent Players in Single-Use Bioreactors Market are as follows:
- ABEC
- Cellexus
- Celltainer Biotech BV
- Distek Inc.
- G&G Technologies Inc.
- GPC Bio, among others
Introduction of Large-Scale Single-Use Bioreactors Set to Drive the Single-Use Bioreactors Market
Traditionally, single-use bioreactors were restricted in size due to pressure challenges from the increased weight of the liquid medium in larger volume bags with 2,000 L being the upper limit. Therefore, if bio manufacturers required larger volumes, they had to run several systems in unison or opt for stainless-steel tanks.
However, in the last years, considering strong demand from pharmaceutical companies and contract development and manufacturing organizations (CDMOs), several single-use bioreactor manufacturers have launched large-scale single-use bioreactors which are expected to fuel the Single-use Bioreactors market growth in the coming years.
Aligned with this trend in March 2021, Thermo Fisher launched 3,000 L and 5,000 L HyPerforma DynaDrive single-use bioreactors. It is touted as next-level innovation in single-use bioreactors market with unmatched design, scalability, and performance. The system provides improved performance and scalability to larger volumes and is suitable for fed-batch and perfusion processes.
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