Bioreactors are vessels for cell culturing and have been widely used for much of the past century. Systems employ glass vessels for smaller applications (up to 20 L) and stainless steel tanks for larger reactions, and were cleaned or autoclaved and reused. In the past decade, the technology underwent a technological change with the introduction of single-use, disposable bioreactors. The technology is similar to traditional bioreactors, but instead of a culture vessel that needs to be sterilized after each use, it employs a disposable bag.
The advantages of single-use bioreactors include reduction of cross contamination that can result from improper sterilization of conventional systems, and substantially less service and maintenance. The shaking or rocking mechanism alongside a variety of disposable sensors is integrated into the disposable culture bag, eliminating complex moving parts found on conventional bioreactors. A drawback of single-use systems is the consumables cost for disposable bags and sensors. However, that cost is somewhat offset by the time and costs of cleaning and sanitizing stainless steel systems.
Sartorius is a major supplier with its CultiBag, UniVessel and BIOSTAT lines. CultiBag has a working volume of 10–2500 L and is used with orbital shaking units. This line is among the few in the market with a volume exceeding 2,000 L. UniVessel is designed for laboratory-scale users and has a working volume of 600 mL–2 L. It integrates several disposable sensors including DO and pH. The BIOSTAT series comes in RM and STR models. The RM utilizes a rocking motion and has a capacity of 100–300 L. The STR uses a stirrer and has a working volume of 12.5–1,000 L.
Other key suppliers are Eppendorf and Thermo Fisher Scientific. GE Healthcare, another top manufacturer, offers the WAVE and Xcellrex product lines. The company entered the market with its acquisition of Wave Biotech in 2007 (see IBO 4/30/07) and of Xcellrex in 2012. The WAVE line uses rocking technology and has systems with volumes of 100 mL–500 L. Xcellrex products are mainly used in GMP labs given its high capacity of up to 2,000 L. Unlike the WAVE system, Xcellrex products use a stirring technology. Eppendorf’s bioreactor offerings are due to its 2007 acquisition of New Brunswick Scientific (see IBO 7/15/07). Eppendorf makes the CelliGen BLU system, a benchtop unit for laboratory-scale use, with capacities of 5 L and 14 L. Thermo offers the HyPerforma and HyClone systems.
The market for single-use bioreactors is expected to grow in the high single digits for the next few years, fueled by research and clinical-manufacturing applications. Expected advances include improved quality, more integrated disposable sensors and the use of more environmentally friendly materials. The economics favor single-use over traditional systems for many applications, and widespread adoption into GMP biopharmaceutical manufacturing is inevitable.
Single-Use Bioreactorsat a Glance:
• GE Healthcare