How Do Temperature Changes Affect the Stability of Biologic Drugs? Let’s Find Out.
Key Takeaways:
- Why are biologic drugs so sensitive to temperature and impact?
- What is the impact of temperature fluctuations on biologic drugs?
- How can temperature be controlled and tracked?
- Learn about future innovations in progress to improve the cold chain.
- Find out how regulatory compliance impacts the cold chain.
The growing demand for vaccines worldwide and the rise of medical home delivery services are pushing the cold chain logistics market value to an expected $892 billion by 2030.
Biologic drugs, also known as biologics or biological products, are medicines made from living organisms through sophisticated biotechnological methods, unlike traditional drugs, which are chemically synthesized. These include therapeutic products like proteins, antibodies, nucleic acids, and cell-based therapies.
The demand for biologic drugs and vaccines is surging, yet these products are extremely sensitive to temperature changes. These variations during transportation or storage can compromise their stability, posing a direct risk to patient safety. Damaged drugs fail to serve their therapeutic purpose, lead to financial losses for manufacturers and logistics providers, and delay patient treatment.
Stricter global and national regulations have been established to ensure pharmaceuticals are manufactured, stored, and transported under conditions that maintain their quality and safety. This overview emphasizes the impact of temperature fluctuations on biologics and explores upcoming strategies for temperature management throughout the cold chain.
Impact of Temperature Fluctuations
Biologic drugs are susceptible to various temperature-induced changes, including denaturation, aggregation, and precipitation, which can compromise their therapeutic properties. For instance, fluctuations outside the optimal storage conditions can accelerate degradation processes, leading to a loss of potency and increased immunogenicity, leading to adverse immune responses in patients.
This sensitivity to temperature variations showcases the need for stringent temperature control measures from the production phase to the patient’s administration.
Even slight deviations from the recommended temperature ranges can affect the efficacy and safety of biologic drugs.
Temperature Control in the Cold Chain
Biologic drugs, including gene and cellular therapeutics and vaccines, are the future and foundation of personalized medicine. Most require standard refrigeration (2-8°C) or need to be frozen at -20°C. Others may require being deep frozen at -120°C or below. Temperatures must be maintained throughout shelf life in storage and when products are shipped to consumers.
Maintaining temperature control throughout the cold chain presents several challenges, such as the need for:
- continuous monitoring to ensure temperatures remain consistent.
- adhering to strict temperature ranges specific to each drug.
- rapid response capabilities to address any temperature deviations.
Maintaining a strict cold chain process is crucial for the quality and safety of medications. The best practices for cold chain processing include:
- Ensure medications stay cool: Medicines must remain within their required temperature range to prevent them from losing effectiveness and becoming unsafe.
- Monitor conditions regularly: Use systems that continuously check the temperature and moisture levels while medicines are stored or moved, so they stay in good condition.
- Use tracking tools: Use monitoring and data logging devices to record temperature, shocks, and whether the package was tilted can give a full picture of how the shipment was handled.
- Keep detailed records: Documenting the journey of medications from where they are made to where they are delivered helps keep everything transparent and accountable.
- Aim for safe and effective medications: The main purpose of creating and delivering medicines is to ensure they are safe, work well, and are of high quality for those needing them. Being thorough in managing how medicines are kept cold from start to finish supports this purpose, ensuring the well-being of patients and the success of pharmaceutical companies.
Drug development aims to give patients usable, potent, and quality drugs. Properly managing the storage and shipping of each drug requires a dedication to quality for patient safety and business revenue.
When drug supplies are ruined or lost, it doesn’t help the logistic company’s reputation or the pharmaceutical business’s operational costs. Ruined drugs are wasted, and therefore, patients needing them will have to wait longer for them.
Regulatory Considerations and Compliance
Regulatory bodies like the FDA and EMA have set strict guidelines for storing, handling, and transporting biologics to ensure they remain effective, safe, and high-quality throughout their distribution. The US Drug Supply Chain Security Act (DSCSA) is one such regulation. It was created to secure the pharmaceutical cold chain, emphasizing the importance of traceability and safety for prescription drugs.
This act mandates strict compliance, with significant consequences for non-compliance, including business loss, financial penalties, and legal repercussions. It specifies the need for controlled storage and transportation conditions to protect drugs from adverse effects from temperature, humidity, and light.
The DSCSA stresses the importance of continuous, precise monitoring of storage environments and transportation conditions, including room temperatures, refrigeration, and freezing, to ensure drugs meet safety and efficacy standards.
The alignment of these regulatory frameworks highlights a unified goal: to maintain the highest standards of drug quality and safety throughout the cold chain.
Innovative Solutions for Temperature Monitoring
Cold chain logistics is a growing market worth billions of dollars in the US alone. However, the success of biologic pharmaceuticals depends on drug makers and shippers collaborating to ensure regulatory compliance and patient safety.
SpotSee offers a variety of temperature indicators and monitors to provide continuous or scheduled tracking and recording. Our products are tamper-proof and provide proof of shipping quality where the temperature meets all thresholds for the product.
Individual product options range from high-tech, multi-use data loggers and recorders for tracking temperature, humidity, and impact to more straightforward, cost-effective indicators that monitor temperatures and provide evidence anytime the temperature is outside the thresholds.
The future of the cold chain is always in development. It starts with stronger integration between manufacturers, logistics, and consumers. Integrating logistic systems helps improve efficiency, gain visibility into the process, and build a compliant process that better serves each entity.
Future innovations for cold chain include:
- Automation of shared business processing and tracking.
- Improving the environmental sustainability of the cold chain.
- Increase visibility into temperature control and shipping quality.
- Building cold storage facilities for all shipping options.
Want to discover a cold chain monitoring solution? Check out SpotSee for advanced technology options for cold chain management. Let SpotSee find the solutions you need.
Ready to Streamline Cold Chain Operations?
Biologics are the future of personalized drugs and patient safety. Ensuring drug quality from start to finish is good business for every cold chain partner and consumer. Implementing tracking from a variety of device options means there’s a way to meet compliance standards and patient safety.
Make the most of the future of cold chain and leverage SpotSee’s range of monitoring products to ensure you meet the needs for cold chain integrity, patient safety, and businesses.
At SpotSee, we’re dedicated to revolutionizing your pharmaceutical cold chain by offering cutting-edge solutions that enhance product quality and safety and streamline your processes for optimal efficiency.
Our solutions include:
WarmMark® is a time-temperature indicator that provides insights into your cold chain logistics. It will tell you which packages may have experienced temperature excursions. This single-use temperature recorder for shipping turns red when it reaches the temperature threshold you selected.
FreezeSafe™ indicators provide accurate evidence if a product has experienced unacceptably low temperatures. This cost-effective solution allows you to add an indicator to every shipment or mount directly onto the product. Easy to use, FreezeSafe turns from clear to magenta when the temperature falls below its threshold. A simple visual check alerts the recipient if the temperature has been unacceptably cold. Available temperatures include -3°C/27°F, 0°C/32°F, 2°C/36°F, and 5°C/41°F.
ColdChain Complete® offers a cost-effective and reliable solution designed to monitor temperature-sensitive products effectively. Our single-use visual indicators provide accurate and irreversible evidence of temperature excursions, empowering our customers to monitor both cold and hot temperature variations. The ColdChain Complete series comes in two formats – ColdChain Complete and the compact ColdChain Complete XS. It combines WarmMark and FreezeSafe in one convenient application.
Explore our range of cost-effective products, specifically designed for customization to address all your product monitoring requirements. Trust SpotSee to be your partner in advancing industry standards. Contact us!
