As with earlier industry initiatives (e.g., PAT, QbD, personalized medicine), everyone agrees that Biopharma 4.0 is “the future” but a combination of inertia, regulatory uncertainty, and already favorable product pricing and reimbursement diminish the perceived imperative to change: The spirit is willing, but the flesh is weak, or perhaps at least “comfortable.”

In an environment so dependent on physical assets like equipment, unit operations, discrete upstream and downstream processing, and the necessary biological constructs (cell lines, viral vectors), overlooking the critical role of software and IT in supporting 4.0 is a common error. Companies tend to think of improvements leading to “4.0 Nirvana” as originating with hardware—the “hard” part of 4.0—and only afterwards worry about managing information/data.

Approaching the problem from the software side is not only possible, but represents an easier path to Biopharma 4.0 provided the software itself can manage change, as for example from batch to continuous steps, or in digitally connecting two previously unlinked operations.

Manufacturing execution software (MES) for pharma/biopharma can be an early component of 4.0-like improvement for existing systems while providing an upgrade path as the situation arises. Honeywell’s recent acquisition of Performix, which specializes in MES, is illustrative. Performix MES joins Honeywell’s portfolio of automation software supporting Biopharma 4.0, which includes the (also) recently acquired quality management products from Sparta Systems.

Data and compliance requirements

By addressing a biomanufacturer’s data and compliance requirements across product lifecycles–from automated project execution to optimizing production to quality—the software supports 4.0 flexibly, accommodating hardware and production system upgrades as they occur.

The modular Performix’s MES suite supports product manufacturing through digital procedure and batch applications that include the product recipe, workflow instructions, and lot numbers for traceability. The platform also supplies compliance and audit information while supporting analytics, analysis, and manufacturing.

“Through this portfolio, our customers will be better positioned to achieve proactive quality and compliance, increased efficiency and gain great visibility and insight across manufacturing,” says  Shawn Opatka, vice president and general manager, Honeywell Process Solutions-Life Sciences. “Performix has been our partner for a long time, and this acquisition was a natural step for us. Through this partnership, we’ve seen success in addressing key challenges as our customers move forward in their digital transformation journey.

“Performix also adds deep MES domain knowledge, critical to manufacturing, quality compliance, and helping customers implement best practices. Adding MES to our portfolio adds support for Biopharma 4.0/Industry 4.0, the convergence of informational, operational and processing technologies.”

This transformation, Opatka tells GEN, involves automation of manufacturing processes and workflows, migration away from paper-based processes towards data digitization, plus analytics and analysis to enable proactive and predict manufacturing

“MES are critical in life sciences, irrespective of the process,” he continues. “These products have been deployed successfully for decades in pharmaceuticals to ensure compliance to such regulations as FDA 21 CFR Part 11 and are considered a best practice. With the emergence of ‘advanced’ therapies such involving cells and genes, MES plays a critical role by capturing, in a single record, all manufacturing batch data, batch-related quality control data, electronic signatures, etc.”

A “typical” bioprocess batch record may involve up to 45,000 manual entries, which represent 45,000 opportunities for error.

The other role MES plays is providing traceability and genealogy of all lots manufactured. “This will become important as these new therapies emerge,” Opatka says.

In this environment, with personalized medicine trending, the number of lots will grow exponentially as batch sizes shrink. “This will lead to increased complexity in data capture, data integrity, trackability/traceability and this will be where MES provides business value,” adds Opatka.