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.
Capabilities
- Controlled storage and distribution at ambient, refrigerated (2-8C), frozen (-15 to -25C), ultra-low frozen (-40C to -60C, -70C to -90C) and cryogenic conditions (-190C)
- Biorepository
- Serialization
- Continuous monitoring solutions for all shipments
- GMP kit design and production
- Cold chain supplies management and ecofriendly reusable shipper program
- QP Release for UK and EU shipments
- Just-in-time packaging, labeling, and distribution services
- Total transportation management
- 14 purpose-built GMP/GDP compliant facilities, located across five continents
- CGT commercial packaging, labeling and distribution in US and EU, including serialization.
Services
Cold chain storage and distribution
- 14 facilities with temperature conditions ranging from ambient to cryogenic
- Biorepository
- Zero temperature excursion with no Time Out of Environment (TOE) fulfillment
- Validated and re-usable shippers (passive and active)
- In-transit temperature monitoring and reporting
- Validated and re-usable shippers
Secondary packaging and labeling
- All packaging and labeling conducted at temperature
- Patient-specific identification labels, collection containers, and administration kits
- Customized just-in-time packaging and labeling workflows based on your processes for time sensitive drug dispatch
- Translations and regulatory guidance
- Label and component printing and validation
Kit production
- Complex, customized kit design with clinical and non-clinical supplies at any temperature, including cryogenic
- Project-specific kits for the pre-manufacture collection of biological samples, investigative site preparation and subject administration, and post- administration sample collection
Laboratory services and processing
- Vector sequencing
- DNA and RNA extraction
- Molecular characterization through next generation sequencing and bioinformatics
Helpful Resources
Inforgraphic
Cold chain services for clinical trial success
This interactive infographic highlights Patheon’s capabilities for maintaining cold chain integrity across the supply chain. Utilizing our global network and expertise, our end-to-end cold chain management services can support your advanced clinical trial needs.
View Infographic
Article
Prepping for commercialization through supply chain logistics
Read the following article for insights on common supply chain challenges and considerations when preparing for commercialization of cell and gene therapy products.
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eBook
The Challenge of Keeping Cool: End-to-End Temperature Management for the Clinical Supply Chain
Learn about managing the storage and transportation environment, what the regulatory definitions are, and planning for end-to-end temperature management.
Brochure
Transportation Solutions for Cell and Gene Therapy Supply Chains
Learn key considerations for evaluating transportation partners for your cell and gene therapy supply chain.
View Brochure