Lowering cost and increasing speed of biologics production

With protocols for bioprocessing firmly established, there is an increasing focus on reducing the cost of producing biologics, biosimilars, mABs, and other modern medicines requiring bioreactions. Producing these pharmaceuticals promises to revolutionize the 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: single-use and continuous bioreactors.

Single-use 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 bioreactors, 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. This reduces initial material costs and time required in between batches.

Fast and flexible mass flow control

Continuous bioreactors have been described as the “holy grail” of biologic production. While these reactors are still a developing technology, they offer the exciting promise of extending production times from weeks/months to months/years. As with single use reactors, this would minimize the need for sterilization and greatly reduce the cost per run.

For this promise to be realized, homeostasis needs to be achieved by extremely accurate and responsive control of conditions within the reactor. Alicat’s mass flow controllers from the MC-Series can be used to help overcome this challenge by providing extremely accurate, responsive gas flow control:

• Accuracy as good as 0.1% of full scale
• Repeatability of ± 0.02% of full scale
• Preloaded with 98+ NIST-traceable gas calibrations, including air, CO2, and oxygen
• Controllers can be moved between systems as needed, providing redundancy at lower price points

The high controllable range of the MC-Series controllers (0.01% to 100%) further improves scalability, as one controller can be used for flows from a few SCCM up to SLPM ranges.

Save space with compact modules

In bioprocessing, particularly in sparging applications, Alicat’s BASIS Gassing Module provides enhanced control over gas inputs with high repeatability precision and fast control, crucial for maintaining optimal cell growth and product yield. BASIS is especially suited for integration with both single-use and continuous bioreactors, aiding in the efficient optimization and scaling of production processes.

This ultra compact gas control solution delivers high performance despite the size. Our modules are custom-built to fit seamlessly into your process, simplifying engineering and ensuring easy integration.

Key specifications include:

• Flow Reading Repeatability: ± 0.25%
• Flow Reading Accuracy: ± 1.5% (gas-dependent)
• Control Response Time: As fast as 100 ms

BASIS has a high capability to provide precise and responsive gas control, supporting the rigorous demands of modern bioprocessing.