In order to cultivate cells at large volumes, bioreactors are used in order to control parameters such as temperature, pH, dissolved oxygen, and metabolites. Bioreactors can be used to scale up cultures as seed trains or to produce large quantities of cells for biotherapeutic or vaccine production.
Over the past several years, single-use bioreactors have grown in popularity due to several advantages over conventional multi-use options. Single-use bioreactors are equipped with a disposable bag, pouch, or rigid plastic vessel instead of a reusable culture vessel. One major advantage of single-use bags is that they are supplied sterilized, typically via gamma irradiation. This eliminates the need for timely and costly steam-in-place sterilization and sterilization verification required in conventional, stainless steel bioreactors.
Another factor driving the demand increase for single-use bioreactor bags is that over the past few years they have evolved to have larger and larger volume capabilities. Many single-use bioreactor vendors now offer options up to 2,000 liters or more. This has allowed end users to adapt single-use technology for not only lab- and pilot-scale processes, but now also to production-scale volumes. The resistance of bioreactor bags to mechanical failure from cyclic stress has enabled single-use bioreactors to scale up. Mechanical robustness is important to end users who require mitigated risk for leaks due to bioreactor bag failures.
New plastic materials and production processes are being used by manufacturers to ensure even higher quality products. Extractables and leachables, which can adversely impact pharma processes, are now being eliminated from plastic formulations used. Often slip agents or other additives to the plastic formulations result in toxic compounds being released from the plastic materials, negatively impacting product yield. New innovations and formulations have resulted in cleaner bioreactor plastics for more biocompatibility.
The addition of new single-use sensors is also driving the increasing popularity of single-use bioreactors. Parameters such as dissolved oxygen and pH are critical for cell culture processes. Single-use sensors are supplied pre-sterilized and allow measurements of culture conditions in an aseptic manner. Standardization of connectors, luers, and ports are also driving their increased adoption. Standardization allows better ease-of-use and enhanced cross-compatibility with other items, such as pumps and tubing lines.
Applications such as cell and gene therapy and personalized medicine are the main growth drivers of the single-use bioreactor bag market. Small-scale cell culture in a sterile and controlled setting make single-use well-suited for these exciting applications. The expansion of CRO labs globally is also contributing to the increase in single-use popularity.
For further detailed information, The Global Laboratory Consumables Market 2020 from SDI covers the in-depth market dynamics, current sales, and projections for single-use bioreactor bags and many other laboratory consumables.