Modular System Design
"The industry is moving toward disposables every day," but there is certainly room in the market for both traditional and disposable technology, and there are hurdles that disposables have not yet overcome in terms of large-scale production, says Stephen Mitchell, president of Appropriate Technical Resources (ATR; www.atrbiotech.com). For modeling of large-scale processes and for scale-up "you are forced to work in the format you will eventually develop the product in," Mitchell says.
Manufacturers of bioprocess systems will benefit from burgeoning interest in the use of biomaterials, such as corn and sage grass, for products, such as plastics and fuel additives, notes Mitchell.
The newest member of the ATR product line is the Infors Multifors system (a replacement for the Sixfors system) that has a volume range of 80-500 mL. Sold in multiples of two vessels, the Multifors offers users the flexibility to expand the system as needed. Infors plans to develop disposable vessels and components for use with the Multifors.
Also new is the Techfors-S with CIP/SIP capability. It is available with double-jacketed stainless steel vessels in total volumes of 7.5, 15, or 30 L and is designed for transitioning bacterial and cell culture systems from the lab bench to pilot-scale production.
ATR has placed three of its TerraFors systems at beta reference sites for use in bioremediation applications. The units enable in-earth biological modeling in the laboratory. "Solid-state fermentation also has interesting implications for production," notes Mitchell.
HEL Inc. (www.hel-inc.com) launched the poly-Block multireactor system earlier this year. The poly-Block can accommodate four or eight vessels that operate in parallel with independent temperature, stirring control, and liquid dosing. Customers have the option of glass or autoclavable steel high-pressure vessels in volumes of 1 mL to 250 mL and can choose to add sensors for on-line, real-time monitoring of pH, dissolved oxygen, pressure, or turbidity, for example.
The main advantages of the poly-Block are its cost and flexibility, says Russell Lee, director of sales at HEL. Users can design the system to meet their cost and application needs. Historically, the demand for systems capable of performing automated, parallel processing initiated in the chemistry groups in big pharma, observes Lee, with slow but steady adoption of automated reactor systems in the biotech sector. He believes that the availability of lower cost, modular systems will continue to fuel that trend.
BioXplore (www.bioexplore.net), a subsidiary of HEL, offers the Expert line of autoclavable glass vessels with stainless steel head plates in the 1-L to 2-L range. These systems are designed for applications such as toxicology studies, bioparameter optimization, expression studies of recombinant proteins, and scale-up, according to Lee.
The new kid on the block for Sartorius BBI Systems (www.sartorius.com) is the Biostat Aplus, a benchtop, autoclavable, laboratory fermentor/bioreactor system designed for small-scale protein expression or transitioning from shaker or tissue culture flasks. It features a four-gas mixing system for cell culture or an oxygen enrichment gas mixing system for microbial culture and temperature, dissolved oxygen, pH, and agitation and fill level control.
Available in volumes of 1-, 2-, or 5-L, the Biostat Aplus includes a laptop PC with local control and supervisory process control software, capable of independently handling up to four units.
Sartorius Biosystems is in the process of upgrading its line of bioreactor systems, according to Maik Jornitz, group vp for global product management bioprocess/biosystems. The upgraded Biostat Bplus system includes a range of preconfigured application-based packages, a 1-10-L UniVessel culture vessel, a multifunctional integrated gassing system, and optional redox and turbidity monitoring.
Jornitz reports continued strong demand from the fermentation sector, with a trend toward standardization and off-the-shelf, modular systems rather than the custom-engineered approach favored in the past for systems up to about 500 L. Standardization will help meet the industry's demand for faster delivery times and reduced capital expenditures.
The focus is now on an assemble-to-order approach rather than a build-to-order mentality, says Jornitz.