“When we started this collaboration with Cyth, we just expected to get something that was 'good enough' to show our investors. Between the rapid development and market-readiness of the design, Cyth far exceeded our expectations. We look forward to having them manufacture our units when we go to market. ”​

CEO, Biotech startup

Project Summary

A biopharmaceutical startup with novel bioreactor technology needed a flexible prototype to rapidly refine cell therapy production recipes within months to secure investor funding. Cyth delivered a comprehensive control system solution that enabled rapid prototyping and iteration, allowing the startup to demonstrate their prototype to investors in three months and exceed funding goals.

System Features & Components

• Breakthrough bioreactor technology with unprecedented cell growth yields poised to disrupt industry

• Three months to develop and refine prototype system to secure investor confidence during next round of funding

• Regulate temperature, moisture, carbon/oxygen levels, mass flow, and pH levels with microsecond-levels of precision

•  Flexible control system that can be efficiently integrated into future bioreactor models

Outcomes

Rigorously tested prototype enabled the startup to demonstrate unparalleled cell growth yields, secure investor confidence and exceed their funding goals. This success positioned them for accelerated market expansion with a scalable control solution for rapid product line growth.

Technology at-a-glance

Hardware

• NI sbRIO-9608

• Cyth Circaflex-315

• Stepper drives (x4)

• pH monitoring module

• Carbon, oxygen, and nitrogen level sensor module

• Temperature control module

• Mass flow control module

• Fluid flow control module

Software

• NI LabVIEW

• NI LabVIEW FPGA

Critical Medical Therapies

Cell and gene therapies offer groundbreaking treatments for some of humanity’s most common and menacing diseases, yet their cost and production complexity hinder scalability. Cyth’s customer, a biopharmaceutical startup, developed a novel bioreactor technology capable of dramatically increasing the yield of cell-based therapies.

To secure investor confidence, they needed a flexible prototype to rapidly refine recipes with minimal downtime and waste. Time was critical, they required an optimized prototype and recipes within months to secure investor confidence and continue developing their innovative product.

By partnering with a control system design expert, they met their timeline, advancing their goal of making life-saving therapies accessible to more patients.

Flexibility or Performance? Why not Both?

Bioreactor systems are used for the research & development of biopharmaceuticals like vaccines, cell therapies, and gene therapies. The most expensive gene therapy available today costs $4.25M per dose (Buntz, 2024), with the average cost of gene therapies costing between $1M and $2M per dose (2023), making reliability and precise control during production a necessity.

These self-contained systems regulate all aspects of the cell culture vessel, including:

• Temperature

• Moisture

• Carbon and oxygen levels

• Mass flow valves

• pH level

Depending on the cell-based therapy produced and intended yield volumes, there is a lot of variation in the number and type of system I/O, making it necessary to leverage a control system that is capable of coordinating complex control loops, while enabling flexibility in accommodating evolving production needs.

With plans to quickly raise a round of funding, then capture and expand market share by releasing a family of bioreactor models, this bioreactor startup recognized the importance of a flexible control solution that would enable them to quickly scale system I/O and build out their product line. 

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“We were initially skeptical that an NI platform-based solution would be a good fit for our product. Once Cyth demonstrated the sbRIO and CircaFlex working with our actual devices in a couple of days, we were convinced.”​

CTO, Biotech startup

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This startup had their product requirements finalized, but with a small team and minimal embedded design experience, they knew it would be challenging to develop a prototype on their own.

Rapid Prototyping & Iteration

To get their products to market quickly while optimizing reliability, this startup decided to work with a product design expert.  

For the job, they turned to Cyth Systems because of their proven success in designing novel Life Sciences equipment for broad-based customer adoption.

Cyth worked with this company to transform their requirements into a design, including a core control system, sensors, mechanicals, and a project plan for rapid design iteration, including:

• Creating a prototype system within weeks 

• Incorporating the company’s ongoing product feedback from firsthand use over the course of weeks

• Refining the design into a robust product that is easily manufactured

This startup’s proof-of-concept system required integration of: 

• Stepper drives (x4)

• pH module

• Carbon, oxygen, and nitrogen level sensor module

• Temperature module

• Mass flow (gas release valve) control module

• Fluid flow control module

Cyth selected the NI Single-Board RIO (sbRIO) platform for its:

• Deterministic control and processing capabilities

• FPGA-enabled coordination of complex control loops

• Native compatibility with LabVIEW and LabVIEW FPGA software, enabling the rapid implementation and modification of control and processing features

  
  

The Circaflex platform enhanced the sbRIO’s capabilities by:

• Simplifying connectivity and signal conditioning to mitigate the need for custom hardware development

• Enabling rapid I/O module integration

The sbRIO and Circaflex hardware, paired with Cyth’s field-tested bioprocess software architecture, allowed for rapid implementation and refinement of the startup’s control loops. The prototype enabled them to test out their bioprocesses and assess the machine’s usability.

Through this approach of rapid prototyping and iteration, this startup had a Cyth-tested prototype within a matter of weeks that included:

• High-quality measurements

• Tight synchronization between complex control loops

• Simple UI to enhance and facilitate user experience

• Flexibility to modify recipes in real time

The flexibility of Cyth’s bioprocess control reference architecture enabled this startup to reuse the design for multiple products, helping them rapidly expand their offerings with a solution that scales from R&D through full-scale pharmaceutical manufacturing.

The major components included in the final design were:

• NI sbRIO-9608

• Cyth Circaflex-315

• NI LabVIEW

• NI LabVIEW FPGA

Designed for Scalability

The rapid development cycle and rigorous parallel testing enabled this startup to demonstrate the prototype to investors in three months and exceed their initial funding goals.

“Cyth provided a functional prototype within a couple of weeks, which we tested rigorously in our lab over the course of months. With so much time for continuous improvement and refinement of the design, the final version was nearly market-ready.”​

Project Manager, Bioreactor startup

For investors, the most compelling elements of this bioreactor startup’s prototype were:

• Unprecedented cell growth yields, poised to disrupt the bioreactor industry

• Market-readiness of prototype with a low-risk and high-ROI R&D investment

• Reliability of system, built on an industry-standard hardware platform with a field-tested software architecture

The solution was designed with scalability and repeatability of recipes in mind. The robust, intuitive user experience mitigates the learning curve for users and encourages adoption from the lab through commercialization. System uptime reduces the risk of wasted reagents, and precise control paired with continuous monitoring ensures the execution of recipes exactly as specified by the operator.

As this startup prepared to go to market, they wanted to expand their product line to include more sizes and variants of bioreactors. The flexibility of the embedded reference design made it quick and easy to scale up production on all product lines simultaneously.

Citations

1. Buntz, B. (2024, April 26). With costs up to $4.5M, cell and gene therapies redefine norms. Drug Discovery and Development. https://www.drugdiscoverytrends.com/how-price-safety-and-efficacy-shape-the-cell-and-gene-therapy-landscape/ 

2. Staff, G. (2023, December 27). Cell and gene therapy manufacturing costs limiting access. https://www.genengnews.com/insights/cell-and-gene-therapy-manufacturing-costs-limiting-access/

Single-Board RIO