Lowered Cost and Increased Speed for Biologics Production

 by Mic Chaudoir

With protocols for bioprocessing now firmly established, there is an increasing focus on reducing the cost of producing biologics, biosimilars, mABs and other modern medicines that require bioreactions. Producing these pharmaceuticals promises to revolutionize treatment of many difficult diseases, especially modern scourges that have been resistant to small molecule-based therapies. Focus on cost reduction and improved speed has centered on two promising developments: so-called “single use” bioreactors and “continuous” bioreactors.

Single use bioreactors lower costs by reducing the time and materials for sterilization and cleaning between production runs. In a conventional bioreactor, all material in contact with the bioreaction requires extensive and thorough cleaning and sterilization to prevent contamination. These processes in turn require extensive use of corrosion-resistant stainless steel and other resistant elastomers and materials. The extensive use of these costly materials is a major driver in construction cost for new facilities. Single use reactors, by contrast, use disposable bags to contain biomass during the reaction. Rather than sterilization, many of the components of these systems can simply be discarded in between runs, reducing initial material costs and time required in between batches. Alicat helps meet the challenge of these systems by offering fast, flexible mass flow control at an affordable price. Alicat’s COMPOSER “Gas Select” feature means that our modern high speed controllers can function for multiple gasses with ASTM traceable accuracy (including, Air, CO2, and Oxygen – over 100 in all). Controllers can then be moved between systems as needed, providing redundancy at lower price points. Additionally, single use reactors are often used to “scale-up” processes. The high turndown ratio of Alicat’s Mass flow controllers (up to 10:000 to 1 in some cases) mean that flows from a few sccm up to slpm ranges can be accommodated with the same mass flow controllers – allowing the mass flow control to scale with the reactor size.

Continuous bioreactors have been described as the “holy grail” of biologic production. These reactors are still a developing technology, but the promise can provide a bioreaction that allows for production over extended periods of time. Instead of typical reactions which are carried out for weeks to months – these bioreactors are designed to run for months to years. As with single use reactors, this would greatly reduce the cost per run. This is accomplished by dramatically extending the time of production between sterilizations. For this promise to be realized, homeostasis needs to be achieved by extremely accurate and responsive control of conditions within the reactor. Alicat can help overcome this challenge by providing extreme accuracy, responsiveness and control for your gas flow needs. Alicat’s controllers have an astonishing mass flow accuracy as low as .1% of full scale and unbeatable repeatability of +/- .02% of full scale readings. Additionally, Alicat supports a variety of protocols and connections to ensure compatibility with your preferences. A custom-built, high accuracy mass flow controller with this level of precision is typically available less than two weeks after ordering!

The speed of biologics development and bioprocess production continue to advance with lower costs, higher speeds and greater flexibility. Shouldn’t your mass flow controller be able to keep up ? Alicat – the world’s fastest flow control company.

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