The Biopharma 4.0 paradigm is built on data. The ability to capture information at each unit operation allows manufacturers to create digital models—to digitize—processes. Analysis of these models reveals patterns and points of optimization.

Biopharma can benefit from industry 4.0, says John Alissandratos, PhD, an independent process engineering consultant.

“I think biopharma has to gain a lot from transitioning to an industry 4.0 framework,” he tells GEN. “I consider the bioprocessing industry nascent considering the progress adjacent sectors have made in the past decade or so, for example, the chemical process industry. The digitization and the ease of data communication and analytics which is one of the pillars industry 4.0 stands on, will help bridge the gap between scientists and engineering working in this sector.”

Future-proof systems

But biopharma has been slow to embrace 4.0, according to Alissandratos, citing the lack of progress in data structures, internet-of-things (IoT) monitoring, and cloud-based manufacturing control. He says this is partly because drug firms are unwilling to swap established methods for the digitized approach until the regulatory implications of doing so are clear.

“Biopharmaceutical compliance and regulatory frameworks are built on experience and methodologies that have been meticulously developed over a span of decades,” continues Alissandratos. “So it is not a shock to see that biopharma is hesitant to risk making the leap towards complete digitization.”

The other bottlenecks are technical, cultural, and financial, according to Alissandratos.

“From the technology side, which is a massive capital investment, most of the technologies are built around batch processes that are often very hard to scale up and inflexible,” he explains. Other industries have recognized this and are slowly making the transition to ‘future-proof’ systems such as continuous flow reactors. There systems are the perfect building blocks for autonomous continuous agile manufacturing, which coupled with QA/QC practices, naturally compliment an industry 4.0 ecosystem.”

Evolving ecosystem

Ultimately, the market will determine whether or not biopharma fully embraces industry 4.0.

Alissandratos noted that “In the cultivation of cells, you tend to find two practices, large-bulk low quality, or low-volume high quality. Neither is suitable for current market trends nor are they adaptable in the ever changing, continuously improving framework of industry 4.0.”

The regulations covering biopharma—specifically those related to product quality—will also play a part, he maintains.

“Regulators are pushing hard for universal quality, and so they should, the capability exists, however there is an inertia in these industries. I would say that currently there we are in the beginning of a systemic change in practice,” he says. “Data analytics, process automation, making a more agile system, continuous improvement, combined with the ability to decentralize manufacturing, and most importantly eventually making it easier for overcoming regulatory hurdles are all massive benefits that this transition brings.”

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