Precision Control System Advances Global Health

Learn how a pharma process startup is exceeding vaccine quality metrics with their disruptive microfluidics technology built on the NI cRIO platform.

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Project Summary

A pharma process startup needed a robust control system to integrate their disruptive pharmaceutical manufacturing IP into a full-scale production line. Cyth delivered a cRIO-based control system with a scalable software architecture for enabling future volume deployments.

System Features & Components

• Enable reduction in cost per dose of vaccine through scale-out of biopharmaceutical production in flexible, localized deployment models

• Mitigate risks to project completion, due to cash flow constraints, through rapid prototyping and extensive parallel testing

• Develop and deploy a cRIO-based system that can be optimized for future deployments on NI's sbRIO platform

• Support the solution's regulatory compliance through highly-vetted system BOM, detailed project documentation and regular weekly collaborations

Outcomes

The beta system exceeded initial purity and homogeneity metrics, demonstrating superior vaccine quality and compelling a multinational pharmaceutical manufacturer to integrate this startup’s technology into their full-scale production line. The precision, reliability and scalability of the solution are helping to further global health initiatives by driving vaccine production costs down and enabling highly-localized manufacturing.

Technology at-a-glance

Hardware

• NI cRIO-9066

• NI C Series modules

• Peristaltic pumps

• Mass flow controllers

• Stepper motors

• Customized industrial enclosure and electromechanicals

  
  

Software

• NI LabVIEW

• NI LabVIEW Real-Time

• NI LabVIEW FPGA

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Reduce Cost with Scalable Technologies

Following the COVID-19 pandemic, the need for equal, global access to high-quality vaccines has become evident. In many parts of the developing world, vaccines are difficult to access and prohibitively expensive. To achieve a 70% vaccination rate, low-income countries would need to increase their health expenditure by 30-60%, while high-income countries would only need to increase theirs by 0.8%.(1)

To help reduce the cost of vaccines in the developing world, and further global health equity, one biopharmaceutical startup is determined to leverage their rapidly scalable microfluidics technology to:

• Increase the shelf life of injectable drugs through precise control in manufacturing

• Enable local production of vaccines in areas with limited infrastructure

• Facilitate the implementation of precise and repeatable vaccine production into continuous manufacturing workflows

  
  

To prove the quality and efficacy of the mRNA vaccines manufactured with their novel microfluidics technology, they needed to provide their pharmaceutical manufacturing end-customer with a beta system capable of:

• Precisely and deterministically controlling fluid flow

• Occupying a relatively small footprint, compared to typical manufacturing “skids”

• Seamlessly integrating into a continuous manufacturing workflow

  
  

To meet this demand, this startup turned to Cyth Systems to bring their vision to life in a few months, ensuring they could deliver an industrialized, robust system to a global biopharmaceutical manufacturer.

Flexible, Deterministic Process Control

Biopharmaceutical production tasks require a delicate orchestration of variables, including temperature, pressure, mass and flow rate. Slight, unexpected variations in any of these variables could compromise the quality and shelf life of the biopharmaceuticals produced, which could result in decreased efficacy of the drug for patients or high costs to manufacturers if regulation compliance is breached.

To ensure the delivery of high-quality and cost-effective vaccines to patients, it’s necessary to:

• Optimize the scalability of bioprocesses from drug development through manufacture

• Mitigate the total cost of goods by minimizing batch failures and maximizing yield

• Maximize the ROI of capital assets through continuous manufacturing processes with minimal downtime

To overcome these challenges, this startup needed a high-performance and versatile platform. They needed instrumentation capable of deterministic, high-reliability process control, while being flexible enough to adapt to changes in interconnected processes in the manufacturing line.

Even though they had clear requirements for the platform they would integrate with their IP, their limited experience with advanced control system design put them at risk of missing delivery deadlines or running out of cash before a final solution was completed.

Scalable and Flexible Architecture

To implement an advanced control system and deliver a high-reliability product to their end customer in a few months, this biopharmaceutical startup partnered with Cyth Systems, an expert in industrial process automation and embedded control systems design.

The solution was built on NI’s CompactRIO (cRIO) platform, a flexible, high-performance control system ideal for complex biopharmaceutical applications. With such high levels of precision and control needed, the platform’s real-time operating system (RTOS) and field-programmable gate array (FPGA), were critical.

NI cRIO-9066 chassis

RTOS key features:

• Deterministic performance: predictable and consistent execution of tasks with minimal jitter

• Real-time control: precise timing and low-latency responses

• Reliability: stable platform for mission-critical applications, reducing the risk of system failures

• Security: native support for Security-Enhanced Linux

  
  

FPGA key features:

• High-speed performance: control loop rates can exceed 100 kHz, enabling rapid response for time-critical processes

• Custom timing and triggering: precise, reliable control of system operations through the implementation of advanced timing and triggering directly on the hardware

• Parallel processing: inherent parallelism of the FPGA enhances overall system efficiency through simultaneous execution of multiple tasks

• Flexibility and customization: software implementation of custom logic, signal processing and control algorithms

  
  

Learn more about NI's Embedded Platform

Cyth worked closely with the startup throughout system development process. Their objectives were twofold:

• To meet the startup’s immediate beta-testing requirements.

• To establish a clear, scalable path to long-term product development goals by implementing a scalable and flexible software architecture.

Custom user interface alongside cRIO with custom breakout boards and wiring, all developed and built by Cyth.

The core aspects of the solution included:

• Real-time control: High levels of time determinism were essential to ensure precision operation and seamless orchestration of processes in the production line.

• Integrated inline sensing: Sensors for temperature, pressure, flow rate, and mass were integrated inline to ensure continuous, closed-loop monitoring of the production process.

• Iterative Development: Regular project meetings were held to incorporate feedback, allowing for ongoing refinement of the system to meet evolving needs.

• Scalable Architecture: The system was designed with scalability in mind, ensuring it could grow alongside the startup’s expanding production capabilities.

Additionally, the cRIO security features facilitated secure, remote access to the system, enabling Cyth to help the biopharma startup incorporate adjustments and optimizations to the system during Site Acceptance Testing.

The final solution was a package of hardware and software:

Hardware:

• cRIO-9066

• NI C Series modules

• Peristaltic pumps

• Mass flow controllers

• Stepper motors

• Custom, folded aluminum enclosure with printed vinyl labels

  
  

Software:

• NI LabVIEW

• NI LabVIEW Real-Time

• NI LabVIEW FPGA

NI C Series Modules

Localized Manufacturing

Cyth transformed the biopharma startup’s requirements into a robust and flexible platform for producing vaccines. The beta system delivered to the biopharmaceutical manufacturer was integrated into a small-scale production line. The vaccines produced exceeded the initial metrics for purity and homogeneity.

Recently, this multinational biopharmaceutical manufacturer decided to integrate this pharma process startup’s technology into their full-scale production line because of its exceptional performance and ability to adapt to future production requirements. Specifically, they highlighted:

• Excellent quality of manufactured mRNA vaccines

• High levels of precision in process control

• Expandability of I/O for more complex, or higher throughput production in the future

• High reliability of system throughout continuous manufacturing testing

  
  

This novel microfluidics solution enables the production of superior quality vaccines in highly localized settings. The high precision, reliability and scalability of this solution are poised to dramatically reduce the cost of vaccine production. As this technology is integrated into full-scale manufacturing, it brings the biopharmaceutical startup closer to realizing its vision of eliminating global vaccine inequity by increasing access to life-saving biologics worldwide.

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Citations

1. United Nations Development Programme. (2021, April 18). Global Dashboard for vaccine equity: Data Futures Exchange. Data Futures Exchange. https://data.undp.org/insights/vaccine-equity