Cold Chain Packaging of Biologics and Biosimilars

Biopharmaceutical products have brought about a remarkable transformation in the medical field, allowing us to prevent and treat diseases that were once considered insurmountable challenges. Yet, these innovative products, known as biologics, and their counterparts, biosimilars, continue to raise questions and intrigue in the medical community.

Biologics, in essence, are pharmaceuticals derived from living organisms. They encompass a variety of types, including those directly extracted from living systems semi-synthesized through recombinant DNA technology, vaccines, and gene therapies.

On the other hand, biosimilars represent biologics that closely mimic an FDA-approved product, performing identically but avoiding legal disputes with the original manufacturers. Essentially, biosimilars are the generic equivalents of biologics.

While biologics often substantially improve patient outcomes, their cost can be prohibitive. This is where biosimilars play a pivotal role. Biosimilars undergo rigorous testing to ensure they offer the same clinical benefits as biologics, boasting equal safety and efficacy. The key distinction usually lies in pricing, as biosimilars are more affordable. This affordability stems from their streamlined development process in comparison to biologics.

Contact us for more information or a custom quote to validate your packaging.

Cold Chain Packaging of Biologics and Biosimilars

Both biologics and biosimilars share a common requirement for cold chain packaging. 

Biologics packaging, including biopharmaceuticals and biosimilars, requires strict adherence to specific temperature requirements to maintain their integrity and effectiveness. These temperature requirements are crucial for preserving the stability and safety of these sensitive products throughout their distribution and storage. Here are some considerations for cold chain biologics packaging:

Cold Chain Packaging of biologics and biosimilars: Many biologics are highly temperature-sensitive and must be stored and transported within a specific temperature range, typically between 2°C to 8°C (36°F to 46°F) or even lower, depending on the product. Therefore, the entire cold chain packaging solution must include all packaging elements, from cooler and refrigerant to VIPs and qualification/validation testing.

Temperature Monitoring: Biologics packaging often includes temperature monitoring devices, such as data loggers or indicators, to track temperature fluctuations during transportation and storage. This real-time monitoring helps identify and address deviations from the specified temperature range, ensuring the product’s quality and safety.

Temperature Stability Testing: Manufacturers conduct temperature stability testing before packaging biologics to determine the product’s sensitivity to temperature variations. This information guides the selection of appropriate packaging materials and temperature control measures. Coming to the table with a temperature profile is ideal, but if not, testing the packaging in transit is needed. This is where our ISTA thermal lab comes into play.

Regulatory Compliance: Expertise in cold chain packaging of biologics is essential, as biologics packaging must adhere to rigorous regulatory guidelines and standards to guarantee the packaging meets the essential benchmarks for safety, efficacy, and precise temperature control. Our team, for example, possesses expertise in various compliance requirements set forth by regulatory bodies such as the FDA, PDA, URAC, ACHC, and other health authorities.

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Need help with Your Cold Chain Packaging of Biologics and Biosimilars?

Our ISTA-thermal testing lab houses a team that provides top-tier biopharma packaging solutions. Our expertise ensures that these vital pharmaceutical products are securely and effectively packaged for distribution.

For more information, please do not hesitate to contact us at 1-800-cold-hot or email at We are committed to supporting the advancement of biopharmaceuticals through reliable and superior packaging solutions.