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
Services
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
Our Basel, Switzerland facility provides expertise in cold chain supplies management with zero time out of environment. Services include biorepository (controlled ambient through -150C) with related CL3 laboratory services, temperature controlled secondary packaging and labeling, and total cold chain transportation management services.
Our Bishops Stortford facility in the United Kingdom provides GMP biologics storage from controlled ambient (15°C to 25°C) to frozen (-20°C) CL3 laboratory services, and cell therapy clinical trial support.
Our facility in Franklin, Massachusetts provides GMP biologics storage and cell therapy clinical trial support. Services include: GMP storage from controlled ambient to (15°C to 25°C) to cryogenic (-150°C), Pick & pack, and Distribution services that include temperature management and monitoring for local or global shipments.
The Frederick, Maryland Cryocentre is a center of excellence for ultra-cold and cryogenic storage and distribution of critical materials. This site offers GMP storage at frozen and cryogenic temperatures, Comparator and Clinical Ancillaries sourcing and management, and Distribution services that include temperature management and monitoring for local and global shipments.
The Rockville, MD site offers biorepository storage as well as laboratory and pharmacy services, ambient pallet storage, cold storage transportation and just-in-time secondary labeling design/printing services.
Our São Paulo, Brazil facility provides local and international regulatory support for clinical trials in this region. Additionally, this facility offers GMP storage at ambient, controlled ambient to frozen temperatures, Secondary packaging in environment - including refrigerated and frozen, and packaging over dry ice for below -20°C materials, and In-house labeling, including cold chain, and expiry date labeling / relabeling.
Our Suzhou, China site is located in a free trade zone where there are zero duty and VAT payments imposed on shipments entering Suzhou. Additionally, this site offers GMP temperature & RH-controlled storage from ambient to frozen, in-house global labeling service, and Primary and secondary packaging at ambient and refrigerated temperatures.
Our Tokyo, Japan site offers cold storage and logistics services such as GMP storage from controlled ambient to cryogenic, Secondary packaging at ambient, refrigerated and frozen temperatures, labeling and expiry date relabeling, Pick & Pack, and temperature management and monitoring distribution services for local and global shipments.
Our facility in Vacaville, California provides biologics storage and cell therapy clinical trial support. Services include GMP storage from controlled ambient to cryogenic, Just in Time packaging and labeling done in environment - including refrigerated and frozen.
The Weil am Rhein cryocenter is our first dedicated Cell & Gene therapy storage and distribution facility in mainland Europe. This facility offers GMP cold storage, collection and administration kit production, customized secondary packaging and labeling solutions with Just-in-Time options available, QP Release, and Cold chain logistics and specialty courier services.
The Bleiswijk facility represents Thermo Fisher Scientific’s latest advancements in the cutting-edge world of cell and gene therapy. This state-of-the-art facility has been purposefully designed to support the growing number of clinical trials taking place throughout Europe and is the exclusive center of excellence and innovation hub for cell and gene therapies within the European Union.
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.
View Article
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