Gene therapy is quickly becoming one of the most talked-about advances in medical science. With the immediate ability to treat a handful of extremely difficult diseases — retinal dystrophy, a form of lymphoma and a type of leukemia, as of now — it is a treatment that shows promise in tackling a large number of other diseases that have resisted treatment. These include other rare diseases, cancers, HIV, Parkinson's Disease, hemophilia and severe combined immunodeficiencies. The treatments have recently qualified for fast-track approval with the FDA, meaning they may be able to reach the market sooner than other drugs.

 

Monitoring of manufacturing, storage and transportation conditions in real time, is an invaluable asset. Data loggers provide trackable data for factors like temperature, humidity, differential pressure , CO2, and particle size for clean room operations, , Data loggers like the Oceasoft Cobalt 2 offer an extremely cost-effective solution in terms of both protection and compliance.

 

We will examine how the Cobalt 2 offers the opportunity to save millions of dollars, protect patients' lives and help meet compliance checks.

 

 

What Is the Cobalt 2?

Cobalt 2 is one of Oceasoft's premier data loggers. With it, users can achieve continuous monitoring in real time for the following factors:

• Temperature
• Humidity
• Differential pressure
• CO2 content
• Particle Size with integration of 3rd party devices

 

This versatility is achieved through Cobalt 2's many sensors. By giving you state-of-the-art, comprehensive monitoring, you can also stay ahead of compliance requirements for GxP and GMP, in a 21 CFR Part 11 environment.

 

One of Cobalt 2's greatest assets is its simplicity and intuitive interface. This means reliable monitoring of your equipment and processes without added time or effort trying to understand the device. If something goes wrong, Cobalt 2 sends real-time alerts via voice calls, SMS/text messaging or email. This means peace of mind for companies for whom small equipment failures can have catastrophic consequences.

 

 

The data end of the Cobalt 2 makes it doubly useful. First, Cobalt 2 uses industry-leading security protocols to keep data safe and secure while interfacing with other information systems. Secondly, its creators prioritized accessibility in the layout of its design. That means a format where searches for data are quick and simple — not frustrating or laborious. Finally, the data produced is auditable. If needed for audits or compliance checks, the data can be provided to the other party in a readily interpreted format.

 

There are over 160,000 data loggers in use across the globe. With the Cobalt 2, you will be getting compliance, a small device profile with a high-visibility LCD screen, exceptional wireless connectivity, unlimited reading storage, different options for units and much more.

 

Cobalt 2 and Compliance

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 2 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 2 is made not only for reliable monitoring but also to aid in all types of auditing by showing traceability in the system. One key to success during this process is being able to present a comprehensive dataset with all of the needed parameters.

 

 

The other key to success in the event of an unexpected audit is being able to provide an audit trail. This document differs from simply showing the auditor a database. In it, the auditor can find traceability of every action taken within the software. Cobalt 2 makes this process simple. For example, if it is being used as a temperature monitor on a product storage freezer and the parameters are set to –80ºC, the audit trail records the parameter at the start date and time.

 

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 2'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 2 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 2 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 2'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 practically no 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 2 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 2, 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.

 

Learn More About the Capabilities of Cobalt 2

If you are interested in learning more about Cobalt 2's ability to save money and protect patient safety, contact Oceasoft with questions.

 

View the Colbalt 2