Drug firms looking to ramp-up production with continuous processes must think beyond the reactor and ensure the technologies used downstream can also manage sustained 24/7 manufacturing.

Continuous manufacturing is not a new idea for the drug industry. Perfusion bioreactors, which retain cells while allowing for the continuous exchange of the growth medium and egress of the process stream, have been used for decades.

But biomanufacturing is not just about what happens in the bioreactor and firms developing continuous processes must keep this in mind says Irina Ramos, PhD, director of AstraZeneca’s bioprocess technologies and engineering group. Ramos told GEN about the need for continuous production-enabled separation technologies, citing a process her team developed that was detailed in a paper last month.

“The downstream process described enables the main unit operations to run at the same time, with the process fit optimizing the utilization of chromatography resins and filters. The main benefit is the ability to run the downstream processes in parallel with the upstream, minimizing the need for volume accumulation and hold of products,” she explains.

“The approach also maximizes productivity in the facility and minimizes the use of expensive consumables, such as protein A resin. This process flow de-risks downstream from being the bottleneck for capacity to process the upstream material.”

Integrated turn-key system

Ramos and her team used an integrated turn-key system developed by PAK BioSolutions to run a 14-day end-to-end monoclonal antibody purification process at a scale suitable for supplying a clinical trial. For automation, the system relied on a PID—a proportional–integral–derivative—controller that takes data from the process and adjusts downstream operations in real-time. The PID can be configured to suit a range of production process types.

Ramos cited this flexibility as a major advantage, explaining “the process flow presented is one example, but others can also be set up.”

The system was also straightforward to install and implement according to Ramos, who says “It takes a full day with two people to set it up. Its set up can be standardized and protocols are in place to simplify routine operations.”

Such turnkey systems are likely to become more common in biomanufacturing, adds Ramos, particularly given growing industry interest in next-generation manufacturing (NGM) and intensified production.

“NGM is also known as intensified or continuous biomanufacturing,” she continues. “It offers opportunities to build facilities faster and smaller, more productive and using single-use components, more sustainable and flexible.”

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