Cold Chain Storage and Distribution

Many of today’s biologic therapeutics are temperature sensitive. Supply chains are becoming ever more complicated with multiple hand-offs. Ensure that the quality of your precious drug substances and drug products is safeguarded through reliable cold chain logistics to:

  • Maintain drug substance and drug product integrity
  • Ensure cGMP compliance throughout the supply chain
  • Provide storage and packaging solutions that meet your needs
  • Involve seamless workflows

Maintaining sample integrity and quality at every point of transfer from collection to shipping or distribution is imperative. Cold chain logistic solutions can help you ensure proper temperature when locating/transporting your materials that require controlled ambient, refrigerated, ultra-low or cryogenic temperatures. Whether moving a substantial inventory of drug substance, drug product, or biosamples or a single-dose cell therapy, Fisher BioServices is an expert in cold chain distribution and management, from ambient to cryogenic temperatures.

When you work with our Cold Chain Logistics group, all shipments are prepared according to standard operating procedures (SOP) and include point-to-point temperature monitoring devices where applicable. Our receiving SOP includes verifying the accuracy of the shipment, inspecting it for damage, capturing data, and additional steps to verify the efficacy of the sample. After receiving, materials are inventoried and then either sent to the lab for processing or placed directly in storage until needed for research.

From manufacturer to patient bedside, we have the knowledge and equipment required for transport of cellular therapies and biologics including vaccines and monoclonal antibodies. We can also ship single patient units to any clinical site around the world.

We offer a reliable infrastructure, with custom liquid nitrogen equipped vehicles and a fleet of validated dry shippers enable us to ship at cryogenic temperatures to any location around the world. We can also transport customer-owned freezers, refrigerators, and liquid nitrogen tanks from one facility to another. We ensure compliance with all federal, state, and local regulations. Our shipping experts are HAZMAT- and International Air Transport Association (IATA)-trained and certified and trained in current Good Manufacturing Practices (cGMP). We hold Centers for Disease Control and Prevention (CDC) permits to import and export infectious agents and can ship vaccines worldwide.

Fisher Clinical Services – Cold Chain Logistics

When it comes to cold chain services, Fisher Clinical Services is the global standard for quality and assurance. With an expansive support network and facilities located worldwide, we provide comprehensive site-to-site connectivity with dependable storage, packaging/labeling and shipment capabilities. Along with proficient monitoring and tracking resources, we optimize every level of the cold chain process to ensure the security of your clinical trial. We have capabilities across the following temperature-controlled conditions:

  • Ambient (15°C to 30°C)
  • Refrigerated (2°C to 8°C)
  • Freezer (-25°C to -10°C)
  • Ultra-low freezer (-70°C to -90°C)
  • Vapor-phase liquid nitrogen (-135°C to -196°C)
  • Liquid-phase liquid nitrogen (-195°C)

Cold chain product integrity across the entire supply chain demands rigorous processes and cold chain expertise of the highest caliber – from packaging, handling, storage and distribution of temperature sensitive Investigational Medicinal Products (IMP), all the way to the investigator site. Fisher Clinical Services recognizes the challenges and complexities in managing a controlled temperature logistics network. Today’s distribution network is becoming increasingly complex with pharmaceutical companies facing new challenges from regulatory adherence, sustainability initiatives, cost pressures and competing priorities. Our services include:

  • Controlled storage and distribution at ambient, refrigerated, frozen, and ultra-frozen conditions
  • Purpose-built, cGMP-compliance facilities
  • Customized storage and packaging configurations
  • Reliable chain of custody
  • 21 purpose-built GMP/GDP compliant facilities, located across five continents, and more than 30 fully audited, partner depots around the world, selected based on drug type or local regulatory requirements

Our continued investment in cold chain storage, as well as distribution capability across the network, mirrors the industry’s evolution to handle increased quantities of complex cold chain biologics. Products are packaged, labeled, picked and packed for distribution and stored within highly controlled areas in compliance with strict quality standards before being released for shipment.

Contact us to speak to our cold chain storage and distribution experts about your biologics project.

Learn More about cold chain management on Fisherclinicalservices.com