Global Distribution, Logistics and Cold Chain Management
You’re ready to initiate testing on your new compound(s) or study material of interest, but how are you going to get your material to the testing facility? Later, how are you going to retrieve them?
Whether you are developing a pharmaceutical, biologic or chemical, designing a shipping logistics plan for the physical shipment of your valuable test material is often the last thing on your mind. However, failing to include this in your research project plan can lead to unforeseen delays. Considering the shipment design for distribution and logistics as early in your program planning process as possible can protect your valuable investments at every stage of the product life cycle, from discovery to regulatory submission.
Charles River’s Specialist Logistics Team can handle the entire shipping design process for you, taking care of necessary arrangements for the safe, efficient, physical movement of your test/ study materials from origin to destination.
Whether a newly discovered novel compound, a preclinical lead candidate, test material ready for manufacturing, or biological, cell, tissue, reagent samples, we have developed the best practices in the industry to provide the flexibility, global access and assurance needed to support the regulatory-compliant movement, management and delivery of your product safely, securely and on-time.
Customized Shipment Design Solutions
Our clients have more types of time- and temperature-sensitive drugs than ever. That’s because the current research and development environment is evolving past traditional chemical-based, small-molecule therapeutics to more complex large-molecule biologics and cell-based products.
No matter what stage of discovery and development or the commodity you are shipping, a tailored shipment design plan that accounts for all aspects of the transport chain is essential to the success of your shipment. Our team’s deep knowledge of logistics and compliance adds tremendous value to your program, resulting in a transparent shipping process better management and distribution, and reduced risk of study delays and/or loss of test material.
Shipment design complexity can vary greatly depending on the nature of the test material, the amount to be shipped, the origin/destination, and the final use of the material at the destination facility. We know when and how to involve third party shippers/consignees and who will be responsible for import duties/taxes to reduce unnecessary delays.
“We aim to use our expert industry knowledge and experience to reduce our clients’ challenges associated with the transport of pharmaceutical, biological, and chemical products worldwide. We expedite the movement of such products while maintaining their integrity and adherence to global regulatory compliance policies.”
-- Specialists Logistics Team
Many of the test materials we receive are both time and temperature sensitive, driving the need for a suitable shipment design solution. We create a smooth and safe shipping process for your material by considering the following:
- Cold chain options and processes (packaging solution and temperature monitoring)
- Transit time (how to deal with delays and temperature-controlled packing failure)
- Transport hazard compliance
- Shipping mode (transport method)
- Shipping project planning and scheduling
- Freight forwarder, courier, integrator, import broker management and options
- Proactive shipment monitoring, tracking, and issue resolution
- Shipping document determination and production
- Regulatory knowledge and understanding to assist with permit and declaration requirements and agencies involved
International shipments can be affected by import clearance delays or rejections if the necessary import and export documentation has not been completed. Failure to consider these factors during the shipment design process can put your commodity in jeopardy. Knowing who is responsible for the import brokerage and delivery and understanding the need for a specific declaration letter helps to achieve a smooth customs clearance.
Charles River wants to make it as easy as possible for you to work with our sites. Our truly customized concierge sample shipping logistics experience gives you peace of mind that your test materials arrive safely and on time to the correct destination.
Specializing in the management of time- and temperature-sensitive shipments around the world, our experience with sample distribution and logistics spans decades across different continents and countries to ensure you receive the advice and expertise you need.
Experience and Expertise
- Investigational medicinal products
- Active pharmaceutical ingredients (API) and excipients
- Cell and gene therapies (live cells)
- Proteins, peptides, bacteria
- Cells and cell lines
- Nonclinical and clinical biological samples
- Blood, serum, tissue,...
- Controlled substances
- Reagents and buffers
- Radiolabeled compounds
Meet the Shipping Logistics Team
Senior Logistics Services Specialist
Bartosz Jasicki is a corporate Senior Logistics Services Specialist, where he is part of a Global ‘Specialist Logistics Services’ team.
He has worked around the world for some of the major specialist freight forwarding companies holding various senior positions within business, including supply chain manager, operations manager, and regional manager to name a few. He prides himself on using innovative solutions and problem solving to help clients with their logistical needs.
Bartosz is originally from Poland and has a Bachelor’s Degree in management and marketing. He previously lived in Australia before moving to the United States, where he currently resides in the Los Angeles area.
Sebastian Tomlin is a corporate Logistics Manager, where he leads a Global ‘Specialist Logistics Services’ team.
This service focuses on the ability for clients to work with our sites globally through the design, implementation, and management of shipment processes.
Sebastian has worked in increasingly senior positions across the world within a specialist life science freight forwarding company, and has experience working in teams on the ground within Europe, North America, Africa, and Asia. He has worked with a variety of companies, from small biotechs to multi-national pharmaceutical organizations. Sebastian’s focused on moving biological and chemical materials around the world and helping with supply chain management to help clients focus on what’s important to them – their research.
Sebastian grew up in the UK and has a Bachelor of Science degree in forensic science. He currently lives in the Boston, MA area.
Global Manager of Logistics
Christopher McEvoy is the Global Manager of Logistics. He has been with the company for over 30 years in varying roles.
Christopher has worked on best practices for handling international trade shipping samples, packaging, and processes for acquiring permits and licenses. Since his transfer to the Corporate EHS group, Chris developed corporate guidance on international trade compliance and adding relevant training sessions on international trade for all sites.
Since moving over to Global Procurement Supply Chain Operations, Chris works with shippers to ensure compliance and best practices, provides training programs for shipping and dangerous goods movement, and also works with the Category Managers and Procurement Operations staff to ensure all products move quickly and efficiently worldwide using the best carriers.
Do I need import/export permits for biological materials?
The concern over safe and secure transport of biological and chemical materials has increased to encompass not only personal and public safety, but integrity of sensitive biological material for research and development. Failure to comply with import and export requirements may result in shipment release delays, cold chain breakdown, or even confiscation at port of entry.
All packages must comply with federal and international regulations as well as specific agencies related to your industry. Therefore, it is important to have a shipping logistics design, distribution and management plan based on your specific commodity’s origin and destination. Our Specialists Logistics Services Team has decades of experience to assist in the planning and safe delivery of your product and can evaluate import/export permits on a case-by-case basis.
Example list of relevant agencies regarding import/export permits:
What are supply chain risks for cell and gene therapy products?
The field of cell and gene therapy is growing rapidly with accelerated regulatory pathways; therefore a test material, many times a single source material, shipment design and viable supply chain plan must be put in place early. This paradigm shift in thinking from traditional drug development starts at the beginning from the collection of patient cells to bedside.
Maintaining the integrity, working condition, time and temperature of allogeneic and autologous cells through the extraction, storage, transportation, and delivery presents a multitude of logistical challenges. A well-planned sample shipping logistics plan will consider cold chain supply (fresh or cryopreserved), packaging to preserve cells, quality control markers, real-time monitoring, and chain of custody, just to name a few critical pieces of the entire plan. Charles River takes great efforts to package, transport, and protect your materials based on the best distribution and logistics design plan so that your product is delivered safely and on time, every time.