Data Loggers in Gene Therapy

Gene therapy is revolutionizing modern medicine, offering groundbreaking treatments for hard-to-treat conditions like retinal dystrophy, certain cancers, HIV, and rare genetic disorders. With fast-track FDA approvals and promising clinical outcomes, the spotlight is now on ensuring these therapies are safely manufactured and delivered. This is where real-time monitoring becomes critical. Data loggers—such as Dickson’s Cobalt X—play a key role in tracking essential environmental conditions like temperature, humidity, and particle levels, ensuring both compliance and patient safety. In this post, we’ll explore how the Cobalt X can help save millions, protect lives, and streamline compliance in the growing field of gene therapy.

What Is the Cobalt X?

Cobalt X is one of Dickson’s premier data loggers, designed to deliver continuous, real-time monitoring across a range of critical factors:

• Temperature
• Humidity
• Differential pressure
• CO₂ levels
• Particle size (with integration of third-party devices)

Its versatility comes from an array of advanced sensors, allowing comprehensive environmental monitoring that helps you stay ahead of GxP and GMP compliance within a 21 CFR Part 11 framework.

One of Cobalt X’s standout features is its simplicity and user-friendly interface. This ensures dependable monitoring of your equipment and processes without the hassle of complex setup or training. If an issue arises, Cobalt X sends immediate alerts via voice call, SMS, or email — giving you peace of mind where even minor failures can have serious consequences.

Cobalt X Data Logger in Gene Therapy

There are obvious advantages to having an FDA- and GMP-compliant data logger. Most gene therapy companies are operating in the stages where the drugs in use are still not FDA-approved, or are in an investigational program. For this reason, they may not require compliance just yet. However, following GxP compliance during this stage of the process is still wise, as approval could mean being audited and needing to prove compliance retroactively. Being able to hand over data that proves compliance during the entire operation can greatly expedite the approval process.

A key benefit of using a Cobalt X for data logging in the gene and cell therapy applications is its ability to save companies significant amounts of money during the auditing process. The Cobalt X is made not only for reliable monitoring but also to aid in all types of auditing by showing traceability in the system.

Save Millions of Dollars and Protect Patient Safety

The cell and gene therapies that are currently in development represent millions of dollars of research and investment that are vulnerable to electrical and mechanical systems failing. The Cobalt X’s real-time alerting features provide insurance against the possibility of catastrophic failures compromising developments.

An example of such a situation is a storage freezer that houses a product. If someone improperly closes the freezer door and the temperature rises too high, this can completely destroy a product the company has been working on for months or years, easily costing half a million dollars. Electrical issues or worn-out parts can also cause such problems. The Cobalt X would notify an on-site employee about the temperature increase so the product could be relocated. This helps protect against product loss in terms of money and time spent on research and development, including both researching the gene therapy and the money on raw materials.

Patient safety is another key issue for cell and gene therapy companies. If the temperature of a product deviates too far from spec, this can have dangerous or lethal consequences for the patient. Gene therapies rely on precise specifications — temperature in a freezer or humidity in a clean room, for example — and if they deviate, the structure of the cell can change and the result can be lethal. Cobalt X protects patients’ lives and ensures that a dip in temperature never goes unnoticed.

Protecting Investments

Protecting the investments put into gene therapies go beyond the facilities in which they are made. Shipping the products out to hospitals and clinics involves packing them in a small vial within a large tank. This setup alone can cost $100,000. The tank is cooled by liquid nitrogen, and if the nitrogen is low and isn’t freezing at the point it should be, the product within can undergo changes. That would mean the company loses a huge amount of money on a single dose for one patient.

Crossing this threshold is a critical step. If a reliable data logger has been in use throughout the manufacturing process, the company can make the transition easily. Cobalt X’s environmental monitoring and audit-friendly software can make this part of the process go smoothly. A company that has performed continuous monitoring throughout the process can simply hand over the needed materials and then move forward. Essentially, this makes a very simple process out of a potentially complicated one, saving lots of money.

Versatility in a Fast-Paced Industry

Cell and gene therapies constitute one of the fastest-moving industries in medicine. Companies are moving quickly because, as of now, there are few gene therapies on the market. In these companies, a great deal of money has been invested in the hopes of becoming one of the top 10 companies providing approved gene therapies — every company is racing to be next.

 One of the side effects of this race is that there is not a lot of time to design and build state-of-the-art facilities. Instead, the new standard is to have clean room companies install pods that can be moved around a facility as technologies develop. This is different from traditional manufacturing, where a company has its dedicated facility and has used it for several decades.

The rise of clean room pods has led to a sort of modular set — the company builds pods and moves them around to meet the manufacturing needs for that particular year. This saves them millions of dollars that they would have had to spend in putting together a full-fledged facility. The Cobalt X has this type of modular spirit built into it.

Some data logger systems are hard-wired into facilities. This means data loggers involve running wires through walls and ceilings with hundreds of feet of cabling that is expensive and a hassle to install. Installers must know exactly where every sensor is and install the corresponding cables through the system.

The Cobalt X, by comparison, is the size of a small walkie-talkie and is both wireless and modular. It comes with five different optional sensors and installing it is as easy as sticking it inside a refrigerator or freezer. If you need to move it, you can — because it is not wired, there is no need to worry about cabling. You can also expand and add on different data loggers as the business changes or expands. You do not need to know the entire layout before you start.