Cold and ultra-cold supply chain management and logistics services

Supporting the packaging, storage, and distribution of temperature-sensitive biologics, cell and gene therapy, and clinical trial materials.

The execution of a successful clinical trial rests on the ability to deliver a viable, potent product. A reliable cold chain management strategy is critical to ensuring your complex therapeutics – such as cell and gene therapies and biologics, including vaccines and monoclonal antibodies – remain viable from the point of collection, through manufacture, and to the final clinical site delivery.

Maintaining product integrity with an experienced partner can help ensure your sensitive biological materials are properly stored and shipped under their required controlled refrigerated, ultra-low or cryogenic temperatures.

With an expansive support network and facilities strategically located across the globe, we provide comprehensive site-to-site connectivity with dependable cold chain 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.

Pharmaceutical cold chain logistics capabilities

  • Controlled temperature storage, packaging, labeling, and distribution from ambient temperatures, to cryogenic conditions (-190C) conditions
  • Cell and gene therapy (CGT) commercial packaging, labeling, and distribution in US and EU, including serialization
  • Continuous monitoring solutions for all shipments
  • Good Manufacturing Practices (GMP) kit design and production
  • Cold chain supplies management and eco-friendly reusable shipper program
  • Qualified Person (QP) Release for UK and EU shipments
  • Just-in-time packaging, labeling, and distribution services
  • Total transportation management


Cold chain storage and distribution

Providing customized solutions to store, pack, label, and distribute your temperature-sensitive biological materials for clinical trials.

  • Biorepository services specializing in long-term biological sample storage and management, from cold to cryogenic temperatures
  • Zero temperature excursion with no Time Out of Environment (TOE) fulfillment
  • Validated and re-usable shippers (passive and active)
  • Real-time Track and Trace for advanced in-transit temperature monitoring and reporting


Secondary cold chain packaging and labeling

Providing right-first-time packaging and labeling of clinical and commercial products at ultra-cold temperatures without Time Out of Environment (TOE).

  • All packaging and labeling conducted at temperature
  • Serialization
  • Standard, custom, and patient-specific labeling solutions applied at temperature
  • Customized just-in-time solutions for time-sensitive drug dispatch
  • Translations and regulatory guidance
  • Label and component printing and validation


Kit production

Designing and assembling sample collection and administration kits for clinical trials.

  • Standard and custom kitting solutions for general purpose, sample collection, or investigational medicinal product (IMP) administration
  • Assembling kits with clinical and non-clinical supplies at any temerature, including cryogenic


Laboratory services and processing

Providing fully integrated sample processing and storage within our biorepository facilities.

  • All samples prepared at temperature
  • Vector sequencing
  • DNA and RNA extraction, purification, quantification, and qualification
  • Automated sample processing, aliquoting, vial capping/de-capping, and labeling
  • Molecular characterization through next-generation sequencing and bioinformatics

Our sites with cold chain services

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