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Over the years, adoption of single-use bioreactors in the biopharmaceutical industry has been on the rise. The growing adoption of bioprocessing systems is mainly driven by various cost saving and other benefits, such as overall ease of use, high throughput, simple sterilization and contamination management. Moreover, single-use systems have a low footprint, are easy to transport and made-up of US FDA approved materials, such as ethylene-vinyl acetate, polycarbonate, polyethylene, and polystyrene. As a result, single-use systems are being preferred over conventional stainless steel bioreactors. In fact, single-use technologies are anticipated to be adopted by around 90% of the biopharmaceutical industry over the coming years. Further, considering their smaller footprint print and operational flexibility, several academic institutes have also started to adopt these technologies. The global single-use bioreactors market is anticipated to grow at a CAGR of around 17%, till 2035, according to Roots Analysis. Driven by the rising demand for different types of biologics across various regions, the single-use bioreactors market is anticipated to witness exponential growth in the coming decade.
OVERVIEW OF SINGLE-USE BIOREACTORS
Single-use bioreactors are disposable vessels used in biotechnology and pharmaceutical industries for cell culture and microbial fermentation. These bioreactors, made of sterile plastic or flexible film materials, eliminate the need for time-consuming cleaning and sterilization processes associated with traditional bioreactors. They come in various sizes, making them adaptable for both laboratory research and large-scale production. Single-use bioreactors offer a cost-effective and highly sterile solution for the cultivation of cells and microorganisms, with built-in sensors and control systems to maintain optimal growth conditions. Their adoption has grown in the biopharmaceutical sector due to their flexibility, scalability, and reduced contamination risks, making them a pivotal tool for bioprocesses and the production of vaccines, monoclonal antibodies, and other biopharmaceuticals.
TYPES OF SINGLE-USE BIOREACTORS
BASED ON CELL CULTURE
Single-use bioreactors can be categorized on the basis of the type of cell culture used in the process. A number of single-use bioreactors are available for processing these cell cultures:
- Mammalian cell cultures: These are in vitro cell line cultures for growing animal cells, including T cells, CHO, HEK293, MDCK, and Sf11. It is worth highlighting that mammalian cell cultures require controlled conditions and are commonly cultured in single-use bioreactors.
- Microbial cell cultures: These cultures are usually grown in in vitro conditions to obtain a pure culture of microorganism for agricultural, biotechnological, and medical research and development purposes. In fact, microbial cell culture have garnered significant interest from biologic manufacturers.
- Insect cell cultures: Insect cell cultures allow heterologous protein expressions, enabling the transfer of the interested protein from the donor species to the host species. As a result, the host’s cellular machinery expresses the foreign protein and performs the desired function.
- Plant cell cultures: Plant cell culturing involves growth and multiplication of plant derived cell lines using nutrient media / solutions in a controlled environment. These cultures can further be utilized to obtain alkaloids, flavors, fragrances, pigments and pharmaceuticals.
- Viral cell cultures: Viral cell cultures are required for the purpose of research. They are used to study interaction of host and pathogen, viral structure, replication mechanism of viruses, identification of virus species and vaccine production. Further, in the light of the COVID-19, many industry players as well as academic and research institutes are using single-use bioreactors for cell cultures for research purpose.
BASED ON AGITATION MECHANISM
Single-use bioreactors can be classified on the basis of their agitation mechanism, as described below:
- Diffusion bioreactors: These bioreactors have membrane bound chamber, which allows the cells to proliferate by exposing them to naturally occurring nutrients and signaling compounds in their native environment.
- Orbitally shaken bioreactors: The culture vessel in these bioreactors’ orbits around a central shaft to facilitate proper mixing. Such bioreactors do not have stirrers or other built-in components.
- Paddle sleeve bioreactors: In these single-use bioreactors, the impellers are designed as two inclined mounted stirrer blades, in order to prevent sedimentation of micro-carriers at the bottom of vessel. These bioreactors are mostly preferred for cultivation of adherent cells.
- Pneumatically mixed bioreactors: These bioreactors make use of gas pressure to move the mixing device instead of a mechanical agitator. The mixing speed is controlled by electromagnets used in the vessel.
- Stirred tank bioreactors: These are the most commonly used bioreactors in biopharmaceutical production. In stirred single-use bioreactors, stirrers are integrated into the disposable plastic bag and are connected to a driver either mechanically or magnetically. These bioreactors can be further classified as top-driven or bottom-driven.
- Wave bioreactors: This first generation of single-use bioreactors include a disposable bag kept on a tray, which moves in a wave like motion to induce agitation for mixing and gas transfer.
ADVANTAGES OF SINGLE-USE BIOREACTORS
Single-use bioreactors offer several advantages over conventional stainless-steel bioreactors, which have been highlighted below.
- Cost-effectiveness: Capital investment and operational costs associated with single-use bioreactors are low, which makes it feasible for the start-ups to install single-use bioreactors.
- Ease of overall installation process: Single-use bioreactors are not complex in their structure and therefore, can be handled easily.
- Increased productivity: Due to faster batch changeover, single-use bioreactors offer increased productivity.
- Low risk of contamination: Owing to the fact that the bioreactor vessel / culture container is pre-sterilized and same bag is not used twice, the probability of contamination reduces drastically.
- Decreased turnaround time: Single-use Bioreactors are ergonomically designed to follow single-use flow path, which in turn reduces the extra efforts required during its set up and installation.
KEY APPLICATIONS AREAS
Single-use bioreactors are used in various area of applications few of the are listed below:
- Biopharmaceutical Production: Single-use bioreactors are commonly used for the production of biopharmaceuticals such as monoclonal antibodies, vaccines, and therapeutic proteins. They allow for quick and efficient scale-up of production processes.
- Vaccine Production: Single-use bioreactors are utilized in the production of vaccines, particularly those involving viral vector systems or cell-based approaches. They enable rapid response to emerging infectious diseases.
- Stem Cell and Regenerative Medicine: Single-use bioreactors play a role in the expansion and differentiation of stem cells for regenerative medicine applications.
- Bioprocess Development: Single-use bioreactors are valuable tools in the development and optimization of bioprocesses. They allow for flexibility in experimentation and reduce the time needed to bring products to market.
- Research and Development: They are used in research laboratories for small-scale experiments, making them suitable for academic and biotech research institutions.
CHALLENGES ASSOCIATED WITH SINGLE-USE BIOREACTORS
Despite several advancements in single-use bioreactors, stakeholders are facing a number of challenges, which have been mentioned below:
- Delay in time: Process customization and fine tuning of environmental factors, including agitation mechanism, dissolved oxygen, material used, pH, and temperature may increase the time required.
- Expensive: Due to the nature of single-use technologies, disposable bags may prove to be expensive in the longer run.
- Pre-existing facilities: Large scale facilities already have well established conventional bioreactors as well as cleaning and sterilization validations for multiple product use.
- Structural vulnerability: Due to stress around the joints, these reactors are vulnerable to physical deformation.
- Temperature sensitivity: Since plastic components cannot tolerate high temperatures, the applications of single-use bioreactors are limited.
- Transportation for disposal: As disposal facilities are not very commonly available, these bioreactors need to be transported to specialized facilities for their disposal, thereby increasing the costs incurred.
CONCLUDING REMARKS
The adoption of single-use systems in small scale R&D activities in the field of recombinant protein therapeutics, monoclonal antibody-based products, and cell-based products is likely to present an opportunity to the stakeholders engaged in the development of single-use bioreactors. The aforementioned opportunity is anticipated to be augmented by the anticipated growth in demand for personalized medicine, microbial fermentation- and cell-culture based products / vaccines, and biomolecules that are being developed to treat rare diseases. Further, the COVID-19 pandemic, along with the associated need to rapidly, mass produce several biological therapy / vaccine candidates, has also played a significant role in the adoption of single-use systems. In the light of all these developments, the single-use bioreactors industry is likely to witness significant growth in the foreseen future.
Roots Analysis is a global leader in the pharma / biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists and strategic investors for more than a decade, we offer a highly analytical / data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights. All reports provided by us are structured in a way that enables the reader to develop a thorough perspective on the given subject. Apart from writing reports on identified areas, we provide bespoke research / consulting services dedicated to serve our clients in the best possible way.
