A single-use bioreactor, also known as disposable bioreactor, employs single use bioreactor bags instead of stainless-steel culture vessel for the manufacturing of various biologics. Disposable bioreactors are complex systems used across numerous sectors of the industry, for the production of pharmaceuticals, nutraceuticals, food, and beverages. These systems provide controlled conditions for cell growth by providing optimum nutrient supply, and oxygenation, enabling the production of biologics. Single use bioreactors can range from small laboratory-scale to industrial-scale systems, and may be operated in batch, fed-batch, or continuous bioprocess.
In addition, during this pandemic, it is believed that the disposable bioreactor market might face supply chain concerns resulting due to the fact that the pre-established biotech and pharmaceutical industries are rapidly growing and consuming much of the capacity for the disposable bioreactor bags. However, in terms of the conventional bioreactors, the supply chain risk will not be an issue, although additional cleaning, sterilization, validation, and comparatively longer turn-around time between batches might reduce the overall efficiency.
Recently, in the biopharmaceutical industry an increasing demand for quality biologics has been observed, where single use bioreactors have emerged as one of the most prominent and reliable solution for biomanufacturing. Disposable bioreactors have transformed the process of conventional biomanufacturing, and their adoption is increasing rapidly for production of various biologics, such as antibody, recombinant proteins, cell and gene therapy.
Presently, a number of single use bioreactor systems are available that can be used for culturing variety of cells for manufacturing numerous biotherapeutics. Specifically in the healthcare industry, the development of novel disposable bioreactor has led to significant advancement in bioprocessing and synthetic biology, enabling the production of innovative biotherapeutics with high yield and quality.
The modern biopharmaceutical industry, which is poised for significant growth over the coming years, is characterized by several blockbuster therapies (such as Humira®, Rituxan®, Lantus®, Avastin®, Herceptin® and Remicade®) and a robust pipeline of product / therapy candidates. Traditionally, stainless steel bioreactors were the preferred choice for production of biologics; however, over the past couple of decades, biopharmaceutical manufacturing has gradually witnessed a shift towards the use of single use technologies. Apart from low contamination risk and better product yield, single use bioreactor are easy-to-install and have a much smaller footprint, compared to the traditional stainless steel systems.
In addition to enabling substantial cost savings (by eliminating the need for additional steps, such as sterilization, cleaning, and maintenance), single use bioreactor are also less demanding of energy and are known to help conserve resources, such as water and CO2. Moreover, the upfront cost of such biomanufacturing solutions is also not very high.