Bioreactors are vessels with complex systems that support and enhance cellular growth or a cell culture. A fermenter is a specific type of bioreactor that is utilized for cultivating micro-organisms, such as yeast or bacteria, in a liquid culture medium. Modern bioreactors offer tremendous flexibility and customization for the type and volume of cells to be cultured. Such bioreactors are most commonly associated with mass production of therapeutic products (bioprocessing), downstream analysis and tissue engineering.
Bioreactors can be classified according to a number of factors, such as cell type (suspension- or anchorage-dependent), cell growth environment (batch or perfusion), as well as types of sensors, impellers and controllers implemented. Based on their volumes and scales, they can also be categorized as benchtop and laboratory (usually <50 L), pilot (40 L-80 L) or production (80 L-5,000 L or higher) bioreactors.
Benchtop and smaller pilot-scale bioreactors are the preferred choice for laboratory research and other small-scale cell culturing needs. These bioreactors are classified by their design: conventional bioreactors, which are autoclavable vessels or units (steel/glass) capable of self-sterilization, or single-use bioreactors (SUBs).
SUBs are equipped with a disposable bag or pouch instead of a culture vessel as with conventional bioreactors. SUBs offer an array of benefits over traditional models by reducing cross-contamination, lowering total cost by over 50% due to faster reuse and fewer maintenance requirements, minimizing labor time and requiring less-stringent validation protocols for regulatory approvals. However, SUBs have certain limitations in terms of functioning capabilities, such as being non-customizable for specific molecules, difficulties with scale-up (beyond 2,000 L) and scale-down, lower rates of oxygen transfer, inefficient mixing or agitation, a lack of multiple batch processing capabilities and disposal issues.
Due to their beneficial attributes, benchtop SUBs are effective for optimizing biopharmaceutical research and applications. Demand for lab-scale SUBs is being driven by the growing biopharma industry and its increasing number of drug approvals. Apart from the biotechnology and pharmaceutical industry, academia is another major user of SUBs since cell culture is an essential part of any life science research.
The total market for laboratory-scale SUBs was over $100 million in 2015. The market for single-use systems is growing about four times faster than the conventional bioreactor market, driven by increasing adoption, the high number of biopharmaceutical approvals and continuous SUB innovation.
The German lab equipment manufacturer Sartorius is the leading supplier of laboratory-scale SUBs, with roughly 15% of the total market in 2015. Sartorius provides both conventional and single-use bioreactors. In contrast, GE Healthcare, which only offers single-use systems, is the second largest SUB provider. Suppliers such as Pall, which was acquired by Danaher (see IBO 8/31/2015), and Eppendorf are other top SUB vendors.
SUBs at a glance:
- GE Healthcare
- Pall (Danaher)