Insights

What does it really mean to digitize biomanufacturing? If you think it’s about converting paper batch records into electronic ones, you’re missing the point—and likely missing the opportunity.

At Pharma MES 2025, Mike Cody, head of digital operations at Zaether, delivered a provocative and energizing keynote. His message? Stop digitizing the past. Start designing the future.

 

The Digital Disconnect

Despite all the excitement around AI and predictive analytics, the reality on many biomanufacturing shop floors is still stuck in the early 2000s. USB drives, paper records, siloed systems—these remain the norm. And while visionaries talk about lights-out manufacturing, Mike Cody pointed out the brutal truth: many plants haven’t even connected their first bioreactor to a digital system.

So what’s standing in the way? Cost concerns. Risk aversion. Excuses like “talk to me in two to four years.” But in Mike’s words, delay is the real risk.

 

Why Batch Records Aren’t Enough

Most digital initiatives start by digitizing batch records. But Cody flipped the script with a deceptively simple question:

“How do you do your job?”

That question reframes everything. Batch records were designed for a paper world—linear, rigid, and often disconnected from how work is actually done. The result? Systems that don’t reflect reality and digital tools that frustrate the very people they’re meant to empower.

 

A New Blueprint: Capabilities Over Documents

Zaether’s approach is rooted in capability-based thinking—breaking complex operations into modular, reusable components (like filtration or material charging) that can be digitized, validated, and scaled with ease.

Here’s how that philosophy came to life in three real-world projects:

1. Tulip: Designing for the Operator

Client: A gene therapy company
Problem: Operators were juggling multiple systems and logins to complete a single task like pH measurement.
Result: A 20-minute task dragged on and morale suffered.

 Zaether’s solution with Tulip:

• Created a unified digital interface for all operator tasks.

• Simplified SOP execution and device interaction.

• Reduced task time from 20 minutes to just 5.

“This is a developer mindset. You’re not just digitizing batch records—you’re designing value.”

2. HiveMQ: Real-Time Data Flow

Use case: Seamless device integration
Challenge: Siloed data and complex hardware configurations

HiveMQ was used as the MQTT broker, enabling:

• Real-time data exchange between equipment and systems

• Simple and robust integration with platforms like Tulip

• Scalable, flexible infrastructure for future workflows

HiveMQ became the data backbone, powering operator-friendly interfaces and agile system orchestration.

 

3. L7 ESP: Modular Process Management

Client: Large CDMO with 300+ batch record variations
Problem: Impossible to manage and scale traditional digitization approaches.

Zaether’s solution using L7’s ESP platform:

• Broke records into modular capabilities (e.g., aliquoting, pH adjustment)

• Enabled hub-and-spoke architecture with version control

• Empowered sites to define and scale processes across the enterprise

“Think in capabilities, not monoliths. You’ll move faster, validate easier, and scale smarter.”

 

Three Pillars of Next-Gen Digital Operations

Mike Cody outlined three essential focus areas for transforming biomanufacturing:

1. Enable the Operator Experience

Digital operations should begin at the point of impact: the people doing the work. The future isn’t paper converted to PDFs, it’s workflow-aware, intuitive systems that actually help operators.
Zaether’s philosophy is rooted in designing for the real job, not just replicating legacy documents in software. Whether it’s simplifying a pH adjustment from 20 minutes to 5, or giving operators a single interface instead of four logins, the focus must be on value-driven digitization.

New tools like Tulip, enhanced by real-time data brokers like HiveMQ, allow operators to:

• Navigate tasks intuitively
• Interact with devices in one place
• View “what’s next” at a glance
• Work in environments where digital feels seamless — not bolted on

 

2. Enable Change Management

At Pharma MES 2025, one trend was loud and clear: companies that move fast, win faster. But moving fast in biomanufacturing doesn’t mean chaos, it means building systems that support change.

Change isn’t just inevitable, it’s a competitive advantage. But only if your systems are built to support it. That’s why leading CDMOs are ditching monolithic MBRs in favor of capability-based architecture, supported by platforms like L7 ESP.

 

3. Enable Growth

Forget project-based mindsets and five-year waterfall roadmaps. In the new digital paradigm, capabilities are your growth currency. You don’t deploy a monolith—you deploy a library of digital skills.

This shift—from “how do we digitize this batch record?” to “what reusable capabilities are we building?” turns manufacturing sites into platforms for innovation.

 

Final Thought: Build for What’s Next

The real transformation isn’t AI, UNS, or MES. It’s rethinking how we work, from the operator to the enterprise level. At Pharma MES 2025, the standout players weren’t just showing tools, they were showing how to connect people, process, and data into a living, adaptive system. From single-use skids to isolators, from paper logs to predictive models, biomanufacturing is changing fast. Cody closed with a challenge: Are your systems, processes, and mindset ready for the next 5 to 10 years?

 

“If you start thinking about what technology is enabling on the data side—and what it’s enabling on the manufacturing side—things are going to be radically different.”

 

Takeaway from Pharma MES 2025: Digital transformation isn’t about replicating the old. It’s about rethinking how we work, empowering those on the floor, and designing systems that evolve as fast as the science.