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Data Loggers in Gene Therapy
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:
- 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 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.
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OCEASOFT Inc. is pleased to announce a new collaboration with AVOGADRO LS, a Contract Research Organization, located in Fontenilles (France) and Terre Haute, IN (USA), providing expertise in various areas including metabolism, pharmacokinetic, safety and efficacy studies for human and veterinary drug development. AVOGADRO LS has partnered with OCEASOFT SA, in France and USA to integrate on both sites the OCEASOFT wireless monitoring solution.
AVOGADRO LS’s challenge was to implement a fully validated and compliant monitoring solution for their critical equipment such as -80°C and -20°C freezers. The solution needed to provide real time data, as well as alerts to the facility staff. Additionally, AVOGADRO LS had a requirement for a solution that to generate customized reports, access to an audit trail of all events and data associated with their facilities and equipment.
OCEASOFT deployed its Cobalt 2 system which meets all the requirements described above. The system is 21 CFR Part 11 compliant and is easily expandable to monitor other environmental parameters such as humidity, differential pressure, CO2 and much more.
Chronicled, Inc. a smart supply chain solutions company based in San Francisco, CA, and OCEASOFT announced a strategic partnership to cross-sell and integrate each other's platforms and solutions.
"By partnering with Chronicled, we gain a solid blockchain strategy. As the pharmaceutical industry in the United States moves onto blockchain to meet its track-and-trace requirements, we can leverage our partnership to integrate these workflows and cold chain monitoring requirements to provide more value and better ROI for customers," says Laurent Rousseau, CEO of OCEASOFT.
"We've discussed cold chain monitoring objectives with many of our life sciences customers," says Ryan Orr, CEO of Chronicled. "Our goal is to make best-in-class technologies available on our platform to meet industry requirements. With wireless connectivity, OCEASOFT temperature data loggers solve many of the problems faced in the cold chain logistics industry, notably eliminating the need for USB plugs; automating data retrieval with BLE, LoRaWAN, and 5G gateways; and offering cross-site visibility of information via apps and a Cloud-based dashboard."
When blockchain meets cold chain
When blockchain and cold chain come together, added value can be achieved with respect to conventional systems, including:
Secure Data Logs for Audit - a decentralized blockchain offers improved security and resiliency properties for record-keeping over a central back-end database.
Workflow Integration – workflows for track-and-trace and temperature logging operations can be synchronized, thus reducing duplicate record-keeping and systems.
Automated Financial Transaction – when a temperature excursion occurs, a smart contract can generate an automated payment to redress impacted parties.
Based in San Francisco, Chronicled is a technology company leveraging blockchain and IoT to bring trust, efficiency, and automation to global supply chain ecosystems. The company is a pioneer in linking physical world economy workflows to blockchain systems and has developed a decentralized protocol and network for supply chain in order to extend trust boundaries and enforce cross-organization business rules without revealing private data. Currently, Chronicled's most active market verticals are Pharmaceuticals, Commodities, and Precious Metals and Minerals.
Changes within the food industry are rampant, spurred on by movements to deliver goods even faster to consumers while accommodating even stricter regulations by agencies like the U.S. Food and Drug Administration (FDA). For many companies, these shifts are introducing additional challenges in food cold chain management.
Here are the five biggest food cold chain challenges to hit the market:
1. How you choose a carrier
One of the most significant hurdles in cold chain management for the food sector is carrier selection. While many businesses focus on the cost of their choice, they learn in a short amount of time that low-cost carriers often cost more by mismanaging products, causing spoilage and in some cases, incurring fines from overseeing agencies. That’s why it’s vital to choose a dedicated carrier that meets all your criteria and provides the following:
- On-time service
- Reliable transportation equipment
- Compliant protocols
- Knowledgeable drivers and dispatchers
It’s also recommended to evaluate your courier on a continual basis. Over time, many can become lax and decrease their level of service, which risks your product and consumer safety. While you can assess your carrier yourself, you can also entrust a third-party logistics (3PL) firm with the task. If you’re unfamiliar with carrier selection, 3PL firms are a sound investment. They’ll compare carriers in your area, as well as their capabilities, plus negotiate their rates for you, which ensures your company receives a competitive price from a trusted shipper.
2. How you manage cold chain information
Data is a critical part of food cold chain management, yet 75 percent of food waste occurs during production and distribution, indicating a substantial gap in communication and supervision by the parties involved. That’s why federal agencies, such as the FDA, are demanding the extensive collection and analysis of electronic records.
In addition to the requests outlined in Part 11 of Title 21 of the Code of Federal Regulations (CFR) — better known as 21 CFR Part 11 — it’s recommended that suppliers in the food industry inspect the facilities of their distributors and wholesalers to ensure they’re producing the necessary information for cold chain records.
During your inspections, review the following factors:
- Pest control
- Standard operating procedures (SOPs)
While some features, such as temperature histories and SOPs, should be available via digital records, others are only accessible through visiting the facility. Third-party firms can conduct these audits on your behalf and check for evidence of information mismanagement, such as the absence of audit trails or modification of records.
3. How you meet cold chain regulations
A continuous challenge of the food cold chain is complying with regulations. Each year, domestic and foreign agencies develop new standards that companies must meet if they wish to continue offering their products to consumers and avoid substantial fines.
The Food Safety Modernization Act (FSMA) poses a significant hurdle too, as it places the responsibility of compliance with the supplier, versus the carrier — unless the contract between the two parties specifies otherwise. Thus, if your carrier violates an FSMA standard, your company is liable.
As a way to counter stricter regulations for food cold chain management, companies are incorporating the standards of agencies into their SOPs, thus requiring every member of their supply chain to adhere to them. Businesses are also certifying their facilities and partnering with accredited couriers, distributors and wholesalers.
Read our article to understand how the food safety modernization act (FSMA) is changing standards in temperature-controlled shipping.
4. How you monitor products in the cold chain
One of the food cold chain challenges that have plagued the food industry for years is monitoring goods. Due to existing technology, it was cost-prohibitive and ineffective to follow a shipment on its journey through your supply chain. The downside of not doing so was an inability to see where and when a product became spoiled.
With wireless technology, however, notably the Internet of Things, it’s now feasible for companies to track the condition of their products from beginning to end. Bluetooth temperature data loggers, for example, are often sent with shipments as they provide real-time status updates to you and your courier’s drivers.
Technology has also entered cold chain food storage facilities. Newer temperature-controlled warehouses, for instance, feature self-contained refrigeration units that offer increased energy efficiency and zero water requirements, plus convenient monitoring systems that use wireless data loggers.
Watch our webinar and learn how the IoT is shaking up cold chain management.
5. How you deliver goods
Amazon’s entry into the food sector signals a shift in how consumers receive their groceries — it also represents a new challenge in food cold chain management. Companies are now preparing for the growing preference of shoppers to buy direct, as well as opt into curbside pick-up, home delivery and more.
These changes lead to new hurdles that challenge the industry to innovate the cold chain even further. Examples of new challenges include ensuring customers pick up or receive their food within an appropriate window for maximum freshness, as well as optimizing routes and expanding distribution locations to access more consumers.
While solutions to this movement are underway, it’s inevitable that the market will need to enhance their infrastructure and streamline their food cold chain management to deliver food that’s safe, fresh and compliant with domestic and international agencies.
Counter food cold chain challenges with OCEASOFT
At OCEASOFT, we bring more than 15 years of experience to the table. Our ISO-certified company, which specializes in delivering innovative solutions for a safer world, develops compliant wireless products for temperature monitoring and more, providing your business with essential information in real-time.
Explore our product line-up to learn more about our innovative and compliant solutions.
After several years of development following its passage in 2011, the Food Safety Modernization Act (FSMA) is now in effect. As the legislation transitions the U.S. Food and Drug Administration (FDA) into a law enforcement authority, versus regulatory agency, it’s critical for shippers and couriers within the food industry to understand its impact on temperature-controlled transportation.
Carry Responsibility for Food Safety
One of the most significant changes ushered in by FSMA is how it delegates the responsibility of food safety. Instead of placing accountability with the individual or organization in possession of a shipment, such as a courier or a distributor, the burden is almost always with the producer or shipper.
Exceptions to this food safety transportation standard are contractual agreements. You may, for example, sign a contract with your courier that states they are responsible and liable for the safety of your food items during transportation. It’s essential to note that accountability can shift back to you. If your contract, for instance, assigns compliance responsibilities to a party not covered by FSMA — thus, anyone other than shippers, receivers, loaders and carriers — your company is liable for their non-compliance.
Develop a Temperature Monitoring Mechanism
In 2011, FSMA required companies to use temperature indicating or temperature recording devices during transportation. That changed, however, and the FDA now mandates that shippers and carriers implement a temperature monitoring mechanism. This requirement is perhaps one of the most critical factors in food safety transportation, as it ensures parties keep products at an optimal temperature for freshness, flavor and texture — which avoids the potential financial losses and brand damage of spoiled food entering the marketplace.
As a part of your temperature monitoring mechanism, your carrier must maintain a record of temperatures. The reason for this requirement is that FSMA mandates that couriers produce documents upon request from either you or the FDA. The most trusted method for fulfilling this food safety transportation standard is via data loggers.
Create Sanitary Procedures
Per FSMA, food transportation must follow the shipper’s established sanitary procedures. For every product your company produces, you will need to develop a set of sanitary protocols, which can detail how to load, store and transport your goods, as well as clean the transporting vehicle.
Provide your instructions in a physical format to your courier — and loaders if the procedures apply to them. If your sanitary requirements change over time, ensure your team revises the existing standards and provides them to your courier and loaders before the next shipment.
If your carrier deviates from your sanitary protocols, it’s vital your company acts, as you’re liable for their non-compliance with food safety transportation standards. Potential actions you can take include modifying your instructions to be more concise, as well as terminating your contract.
Implement a Food Safety Training Program
With FSMA’s passage, it’s critical to review your existing carriers. FSMA requires carrier personnel to undergo food safety training, which ensures drivers, loaders and other staff possess the necessary knowledge and experience to handle temperature-sensitive goods.
The FDA asks that drivers, in particular, undergo a one-hour course before starting. While the FDA is in the process of collaborating with trusted organizations to develop a set of certified classes, there are none available now to accommodate the FSMA’s food transportation standards.
It’s recommended, however, that your couriers direct their drivers and staff to similar courses. This act demonstrates to the FDA that your company and its partners are committed to educating their staff about food safety practices.
Establish Recordkeeping Protocols
As Title 21, Part 11 of the Code of Federal Regulations (CFR) emphasizes, recordkeeping is significant to the FDA. As a result, FSMA mandates extensive recordkeeping by shippers and carriers. The specific focus of documentation in food safety transportation is temperature.
Carriers must provide temperature documentation on request, as well as maintain records regarding vehicle maintenance and performance, fleet movements and routes. Documents like these can often serve as evidence that your drivers understand and comply with FSMA’s food transportation requirements.
Define Preventative and Reactive Controls
Via FSMA, the FDA asks companies to be proactive and reactive. That’s why your business, as a producer and shipper, must establish a food safety plan and risk-based preventative controls, as well as evaluate hazards in your facility and supply chain.
As a part of your hazard analysis, you should identify how your company will manage these risks and counter them if they become an active hazard. You may also implement some corrective actions to alleviate specific hazards. Separate from your hazard analysis, your team should also develop a plan for recalling products.
It’s essential to note that per these new food safety transportation standards, the FDA can now recall food items without your company’s permission. They may only use this power after notifying a producer about the risk of their product and after the producer does not take action.
Meet Food Safety Transportation Standards With OCEASOFT
At OCEASOFT, we develop innovative solutions for a safer world. With more than 15 years of experience, as well as a unique understanding of the regulations surrounding the pharmaceutical, healthcare and food industry, we’ve established ourselves as a trusted and ISO-certified provider of monitoring solutions for a range of applications.
Explore our solutions today and discover how they support food safety transportation standards.