A Guide to Biological Sample Storage for Biopharma Companies

Cold storage and temperature control are vital for the quality of pharmaceuticals and biological samples. Tobin Scientific provides customized cold storage systems and integrated logistics services, maintaining sample integrity from collection to analysis and during transport. We also offer emergency response for unexpected transit disruptions.
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Pharmaceutical companies have a crucial role - enabling healthier, longer lives through innovative products. Clinical trial management is key for ensuring the effectiveness of life-saving drugs, as well as delicate biological samples, and requires meticulous handling, especially in terms of temperature control through proper cold storage.

Temperature control strategy for clinical trials

Temperature control is an absolute necessity for maintaining the quality of pharmaceutical products. Exposure to excessive heat or cold can rapidly degrade their effectiveness. Hence, cold storage plays an essential role in the pharmaceutical supply chain.

Cold and ambient storage for drugs offers several advantages:

  • It prevents spoilage, saving companies money
  • It reduces energy usage and greenhouse emissions
  • It ensures potency, so medicines work as intended when patients need them

Each drug's chemistry and ingredients dictate the strict temperature ranges to be maintained. Some medications need to avoid excessive heat, while others, like vaccines, require refrigerated conditions between 2°C and 8°C. Breaching these temperature zones can render the medicine less potent or even unsafe.

Pharma companies employ specialized cold storage facilities and equipment to maintain these temperatures. Modern cold rooms come in various configurations to accommodate any company's needs - some for indoor use, others for outdoor areas with limited space. The most advanced solutions, like our cGMP warehouse, are highly energy efficient too.

Comprehensive testing and monitoring are essential for maintaining these cold storage systems. Tobin Scientific offers customized cold storage systems that meet this criterion. Their rooms employ precise sensor mapping to track temperatures at multiple points, while data loggers provide a constant stream of readings to confirm safe range maintenance. Our warehouse integrates robust security and access control, precise temperature and humidity, and QMS systems with 21 CFR Part 11-compliancy.

Biological sample storage use cases

Biological sample storage and archival storage can be customized across a range of temperature environments, catering to various types of samples and their specific storage conditions. Here are some use cases:

  1. LN2 (Liquid Nitrogen, -196°C) - This ultra-cold temperature is typically used for the preservation of biological samples such as cells and tissues. For example, some cell therapies, like certain cancer treatments, require this extreme cold to remain viable.
  2. ULT (Ultra-Low Temperature, -80°C to -20°C) - Many biological samples, including DNA and RNA samples, require ultra-low temperatures for long-term storage. This ensures their integrity is maintained until analysis.
  3. Freezer (-20°C to 0°C) - Some biological samples, such as blood samples, need to be stored in a standard freezer temperature range to maintain their quality.
  4. Refrigerated (2°C to 8°C) - A wide range of biological samples, including many tissue samples and biologics, require refrigerated conditions for optimal storage.
  5. Ambient (15°C to 25°C) - Certain samples and medical products that are stable at room temperature fall into this category. They need to be stored at a controlled room temperature to ensure their quality is not compromised.

Each temperature range serves a specific purpose in biological sample storage, ensuring that samples maintain their integrity from the time they are collected until they are analyzed in clinical trials.

Beyond storage: biological sample transport

Maintaining adequate temperature control is crucial not only during the storage of biological samples but also during their transport. Any changes in temperature during the transit process can potentially compromise the samples' integrity, affecting the accuracy of clinical trials.

Using the same provider for storage and transport minimizes the risk of product damage and loss during handoffs. Tobin Scientific understands the complexities of transporting these delicate samples and we offer  end-to-end logistics services that ensure temperature control is maintained during the transport process. With meticulous planning, tight temperature controls, and real-time tracking, Tobin Scientific ensures that biological samples reach their destination in optimal condition.

A dedicated team oversees the entire process, from the initial planning stages to the final delivery, ensuring that all aspects of the transport are executed seamlessly.

Emergency handling of biological samples

Moreover, Tobin Scientific offers emergency response services. In the event of unexpected disruptions or emergencies during transit, Tobin Scientific has systems in place to promptly and effectively respond with redundant generators and real-time monitoring.. This ensures the preservation of the samples and their safe delivery despite any unforeseen circumstances.

By offering these services, Tobin Scientific takes the worry out of biological sample transport. They ensure that samples maintain their quality from the moment they are collected until they reach their final destination, allowing researchers and clinicians to focus on their vital work.