NIIMBL 2025 meeting tackles biomanufacturing data interoperability challenges

Interoperability Challenges in Biomanufacturing

As biopharmaceutical research generates increasingly complex datasets, the industry faces a significant hurdle: integrating disparate digital systems. During the NIIMBL 2025 National Meeting, participants identified interoperability—the ability of systems to exchange and use information—as a primary barrier to operational efficiency. The consensus among stakeholders, including government regulators and private sector manufacturers, is that achieving a smart factory requires standardized data connectivity and ontologies.

The need for this integration is driven by the adoption of Pharma 4.0 technologies, which utilize artificial intelligence (AI) and machine learning (ML) to manage large-scale data. According to industry analysis, AI and ML serve as assistive tools for correlating massive information sets that exceed human capacity. However, experts warn that successful implementation requires specific expertise to ensure data integrity and regulatory compliance, particularly when using complex large language models.

The core of the interoperability debate lies in the transition from legacy systems—which often operate in data silos—to unified digital ecosystems. In biopharmaceutical manufacturing, data is generated at every stage, from raw material testing to final drug product release. When these systems cannot communicate, manufacturers are forced to rely on manual data entry or custom middleware patches, both of which increase the risk of transcription errors and extend the time required for batch release. The push for standardized ontologies aims to create a common digital language, allowing equipment from different vendors to feed data into a centralized, accessible repository.

Scaling Continuous and Integrated Processes

Beyond digital integration, physical connectivity remains a focus for improving bioprocess performance. Linking upstream cell culture with downstream purification is central to reducing facility footprints and costs. As noted by Carrie Mason of Lonza Biologics, the field of continuous, integrated biomanufacturing is gradually maturing.

• Continuous Chromatography: Utilizing multicolumn and periodic countercurrent chromatography to optimize resin use.
• Viral Inactivation: Employing plug-flow reactors or dual tanks to enable transition to continuous downstream processing.
• Filtration: Using single-pass tangential-flow filtration (SPTFF) to streamline buffer and media management.

These physical integrations rely heavily on real-time process analytical technologies (PATs). Without synchronized feedback and feed-forward controls, the complexity of linking multiple units often leads to inefficiencies rather than the intended productivity gains. The integration of PATs allows for real-time release testing, a paradigm where the quality of a product is assured through in-process monitoring rather than waiting for lengthy post-production laboratory analysis. This shift is critical for continuous manufacturing, as any deviation in the process must be detected and corrected instantly to prevent the contamination or loss of material moving through the integrated stream.

Moderna’s Shift in Manufacturing Strategy

The transition from pandemic-era production to an endemic market has forced major players to resize their manufacturing footprints. Moderna, which reported $18.4 billion in mRNA vaccine revenue in 2022, is currently downsizing its network to align with lower demand. CEO Stephane Bancel acknowledged that the company overproduced during the height of the pandemic, leading to elevated costs of goods sold, which CFO James Mock estimated at $3.5–4 billion for 2023.

This restructuring reflects a broader industry trend toward rightsizing facilities. While Moderna continues to operate its 60,000-square-foot plant in Marlborough, Massachusetts, the company is actively reducing its reliance on third-party contract manufacturing organizations (CDMOs). The goal is to return gross margins to pre-pandemic standards, estimated at roughly 20%. By consolidating internal production, companies aim to gain better oversight of their supply chains and manufacturing quality, reducing the logistical complexities inherent in managing a global network of external partners.

Facility Design and Digital Maturity

Facility architecture is evolving to support these digital and physical shifts. Modern designs, such as the Genentech commercial launch facility in Oceanside, California, prioritize the open ballroom concept. By using portable slurry vessels and modular skids, companies can achieve greater flexibility for rapid technology transfers, although this approach necessitates complex cleaning validation for flexible hoses.

The industry remains in varying stages of digital maturity. According to the 2021 Horizons: Life Sciences report, over half of the 502 respondents rated their facilities at Level 3, characterized by vertical and horizontal IT integration. However, the industry’s ultimate goal remains Level 5—a fully automated, self-optimizing plant where quality is verified in real-time, effectively eliminating downtime. Achieving this requires moving beyond the current paper on glass systems that still define many existing manufacturing sites, where digital tools are used primarily to replicate traditional paper-based workflows rather than to optimize processes through advanced data analytics.

“The field of continuous, integrated biomanufacturing is slowly but surely coming into its own.”

The vision of Level 5 manufacturing hinges on seamless data-driven decision-making, though widespread adoption will depend on overcoming technical and cost barriers. As firms invest in these upgrades, they must balance the high capital expenditure required for facility automation with the long-term benefits of increased reliability, reduced waste, and the ability to pivot rapidly between different drug products in a changing market landscape.

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