In recent years, the focus on reduced development and drug production time has intensified, says Peter Walters, director of advanced therapies at CRB. He co-authored a recent study on biopharmaceutical manufacturing innovation drivers.

“By a large margin, speed is the most important driving decision maker. The industry is growing and evolving rapidly right now, and appropriate facilities and equipment to produce these therapies are at an all-time demand,” he tells GEN. “The COVID-19 pandemic set back a significant number of companies from effectively being able to pursue capital projects. Those companies that successfully navigated Operation Warp Speed redefined, for the industry, what ‘speed to market’ can look like.”

AI for routine maintenance

The focus on production speed has increased interest in innovative manufacturing technologies that are able to make processes more efficient Walters says, citing AI as an example.

“AI has shown great potential for improving operations within the biopharmaceutical manufacturing space. Essentially, any operations step that requires a person to evaluate and act can potentially be replaced by an AI-based system. Manufacturing steps, such as visual inspection, can be successfully automated using AI based learning systems, streamlining, and debottlenecking what has historically been a very manual activity,” he explains.

“AI has impacted operations perhaps even more significantly when it comes to central utilities equipment. Companies that have adopted AI-based monitoring systems have enjoyed more efficient and effective facilities.”

Routine maintenance is one area where AI has been applied, according to Walters, who says that rather than performing schedule-based shut-downs companies that use the approach for real-time equipment monitoring can track when systems are showing signs of wear.

“As a result,” he continues, “companies can safely adopt more of a rolling shut-down approach, resulting in greater facility operability.”

Agile facilities

The impact of industry’s desire for faster speed to market is likely to go beyond the adoption of individual technologies and begin impacting facility design, points out Walters, who predicts the plants of tomorrow will be much more flexible.

“The industry continues to innovate around effective process closure technologies, automation, and understanding of risk-based manufacturing approaches. As these are put into practice, it pushes the industry toward a facility where segregation and process protection are driven to the equipment level, with less requirement on the facility,” he says.

“This results in a less restrictive manufacturing environment, and a more sophisticated and controlled manufacturing equipment train. With the continued development and adoption of single-use technologies, these facilities will become hyper flexible and agile, allowing manufacturing companies to achieve a level of unprecedented adaptability.”

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