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Jan 1, 2012 (Vol. 32, No. 1)

Single-Use Equipment on Cusp of Industrialization

  • Supply and Support

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    Integrity™ 2-D BPVs, made with ATMI’s universal Integrity TK8 film, are compatible with ATMI’s single-use mixing and bioreactor technologies and are designed to form a sterile connection between two single-use bioprocess bags.

    But suppliers must also provide configurable or unique systems at the same quality level as standardized products, which requires extra effort from vendors. “It’s easy to tell customers ‘it’s just a bag, put it together.’” Assemblies consisting of 20 bags, tubing, and connectors, however, must be prototyped for usage and packaging. “It becomes an R&D or engineer-to-order project,” Priebe explained.

    To standardization, scale, and GMP-worthiness, Jeff Craig, life sciences global marketing director at ATMI described industrialization as the ability to deploy production-scale single-use equipment at the global level. “New technologies go through a cycle of innovation, early adoption, commercialization, and then finally, industrialization,” he said. “Single use is now in the middle stage of commercialization, and there are similar, predictable industrialization cycles from other industries that we can learn from.”

    Supply chain is Craig’s pet subject. “The discussions are no longer whether single use works, but whether biomanufacturers can get enough product efficiently, on time, and economically.”

    If judged by uptake, then single use is already fully industrialized. “The percentage of companies employing disposables is very, very high,” Craig said. “There are already some approved products using disposables, and many in clinical stage.” Furthermore, he noted that limiting the term “industrialization” to processes that employ disposables end-to-end is a mistake. Some unit operations are perfectly suited, he said, while others are not.

    Over the last five years Thermo Fisher Scientific, has filled out its single-use BioProcess Container (BPC) bioreactor and mixer product lines to cover volumes from benchtop to 2,000 L. Its experience in expanding its product line is reminiscent of how disposable processing itself came into being. In the early days, HyClone, which Thermo Fisher acquired to enter the disposable bioprocessing business, shipped its preformulated media and buffers in flexible plastic containers.

    According to Hutchinson, “Customers began thinking that they might use these BPCs in similar fashion to the containers we were using to ship media and process liquids for collecting downstream process fluids.” Before long customers were commercially using “dry” BPCs for media storage and transport, and, finally, for cell culture.

    Integration of single-use equipment has become a buzzword, but one that is quite useful for understanding evolving customer needs and how vendors can satisfy them. Thermo Fisher’s systems integration initiatives are part of a more general trend toward greater functionality in single-use bags, particularly with respect to controls, automation, and single-use sensors. The industry is asking for these sensors to monitor and control parameters such as carbon dioxide levels, conductivity, temperature, and pressure as well as more common pH and dissolved oxygen.

  • In the Mix

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    PBS Biotech uses U-shaped bioreactors, which incorporate an Air-Wheel that spins and agitates cell cultures through the buoyancy of rising gas bubbles.

    Mixing has been problematic for the single-use equipment industry. If a bioreactor or mixing vessel is to be truly disposable and sterile at all points of use, then that must include everything inside the bag. Disposable bioreactor manufacturers must watch for shear stress on cells while avoiding mechanisms that rub against plastic fluid contact surfaces and possibly release polymer shards or leachable chemicals.

    PBS Biotech (www.pbsbiotech.com) employs U-shaped bioreactors that incorporate an Air-Wheel™, which spins and agitates cell cultures through the buoyancy of rising gas bubbles. As bubbles percolate through the culture they turn the Air-Wheel and avoid the need for external actuation. According to the company this results in rapid, homogeneous mixing and a high mass transfer rate with extremely low shear stress on cells.

    “Gas is required for all bioreactors, so our bioreactor kills two birds with one stone,” said Brian Lee, Ph.D., co-founder and CEO.

    PBS offers scalability from three liters for lab work, and 80 liters for preclinical and clinical batches. In targeting full-scale GMP production, the company plans to produce a 500 L system later this year, and a 2,500 L bioreactor in 2012.

    These volumes, which are fairly common these days, speak to where biomanufacturing is heading in the coming years.

    “Due to personalized medicine and rising titers, we believe that 2,500 liters is probably the sweet spot for single-use bioreactors. The game could change, of course, depending on the market.” In any case he claimed the Air-Wheel is not limited by scale. “Stirred-tank single-use systems have problems overcoming torque requirements to remain truly disposable. A larger Air-Wheel is actually easier to turn with a smaller quantity of gas.”

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