Modular API Manufacturing: The “Plug-and-Produce” Approach for Speed & Flexibility

2. December 2025 |
Flow Plants | News

Key Takeaways

Modular API manufacturing utilizes pre-engineered, standardized units (Module Type Package or MTP) to reduce time-to-market by up to 50%. This ‘Lego-like’ approach replaces rigid plant infrastructure with flexible, scalable systems.

In pharmaceutical development, speed is decisive. Shorter development and processing times translate into faster market entry, unlocking substantial value by extending the effective patent life of an API. One of the biggest time sinks is time-to-process. Modular manufacturing offers a powerful solution.

The “Time-to-Process” Bottleneck

Instead of designing chemical synthesis plants from the ground up, modular manufacturing allows facilities to be built from pre-engineered, plug-and-produce units. This enables companies to assemble their processing plants from existing components rather than developing new infrastructure for each late-stage project or market launch.

The Solution: Plug-and-Produce Technology

Microinnova’s FlowKiloLab® and FlowTonPlant systems show what this future looks like. By combining modular equipment with a modular automation concept based on the Module Type Package (MTP) standard, they enable faster, more flexible, and more sustainable chemical production. Standardized modules can reduce time-to-process by up to 50%, while supporting seamless scale-up from lab to full-scale production. This approach even opens the door to new business models, such as rapid-response production for emergency medicines. Go with Plug-and-Produce instead of building a plant system.

  • Standardized interfaces

  • Pre-built modules

  • Scalability from Lab to Ton-scale

The Role of MTP (Module Type Package)

At the core of this strategy is modular automation. With the MTP standard, essentially “USB for chemical plants”, each module comes with its own automation layer. This eliminates the need for dedicated automation engineers and allows process engineers to configure systems directly. Recent developments, such as modular kilo-lab systems that fit inside walk-in fume hoods, demonstrate how compact and agile small-scale manufacturing can become.

The “USB” Analogy Explained

Think of a traditional chemical plant like an old mainframe computer: adding a new printer required custom coding, specific drivers, and a specialist to install it. In contrast, MTP acts like a modern USB interface.

  • The Module (The Device): Just as a mouse or keyboard comes with a built-in driver, an MTP-enabled process module (e.g., a heating unit or dosing pump) comes with its own automation description file.

  • The Process Orchestration Layer (The Computer): The plant’s central control system (POL) instantly recognizes the module’s capabilities—what it is, what data it provides, and how to control it—without requiring a single line of custom code.

Decoupling Hardware from Software

Traditionally, integrating a new reactor into a plant required weeks of work by automation engineers to map signals and rewrite control logic. MTP eliminates this bottleneck by decoupling the module from the control system.

  • Vendor Independence: Because the interface is standardized, you can mix and match equipment from different manufacturers (e.g., a pump from Vendor A and a reactor from Vendor B) within the same plant.

  • Plug-and-Produce: Process engineers can now “assemble” a plant layout in the software just as easily as they connect physical pipes, drastically reducing the time from concept to production.

Real-World Applications & ROI

Industry leaders are already moving. Hovione is serving as a development test partner, providing real-world feedback, while Merck has implemented the modular automation approach on the scale of an entire development building. A reminder: Standardized modules can reduce time-to-process by up to 50%!

It’s time to Plug, Produce, Customize, Repeat.
Or simply: Produce the next API.

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Frequently Asked Questions about Modular API Manufacturing

Q: How does modular manufacturing reduce the time-to-market for pharmaceuticals?

A: Modular manufacturing replaces the traditional “design-from-scratch” approach with pre-engineered, standardized units. By using “Plug-and-Produce” modules (like Microinnova’s FlowKiloLab®), companies can skip lengthy engineering phases, reducing the overall time-to-process by up to 50%. This speed allows pharmaceutical companies to enter the market faster and maximize the patent life of their APIs.

Q: What is the MTP standard and why is it called the “USB for chemical plants”?

A: MTP (Module Type Package) is a standardized interface that allows different process equipment modules to communicate seamlessly with a central control system. Just as a USB device works immediately when plugged into a computer without custom coding, MTP-enabled modules come with their own automation layer. This eliminates the need for complex, custom integration by automation engineers.

Q: Can modular flow chemistry scale from lab to commercial production?

A: Yes. The modular approach ensures that the technology used in the lab is identical to the technology used in production. A process developed on a FlowKiloLab® system can be scaled up to a FlowTonPlant simply by numbering up (adding more modules) or increasing the runtime, rather than redesigning the entire plant physics.

Q: What is the difference between “stick-built” and modular plants?

A: “Stick-built” plants are constructed on-site piece by piece, which is slow, rigid, and expensive to modify. Modular plants are assembled from pre-tested, off-the-shelf components that can be quickly reconfigured. This flexibility allows manufacturers to switch products or adapt to new market demands without building new infrastructure.