Cell and gene therapy logistics require a complex supply chain capable of handling sensitive materials traveling from the manufacturer, to the 3PL, and eventually to the patient.
Explore how ICS can support you in getting your treatments to patients with our cell and gene therapy supply chain service:
- What is cell and gene therapy?
- The role of the cell and gene therapy supply chain
- ICS cell and gene therapy supply chain solution
- Our services
- Why ICS?
What is cell and gene therapy – and how does the supply chain work?
Cell therapy transfers cells from one part of the body to another for treatment purposes. Gene therapy is adding, removing, or altering genes in a person’s cells to treat a disease.
Specialty cell therapy supply chain solution
The cell therapy supply chain is complex. Cells and genes need to be transported from the lab to the clinic safely and efficiently. Samples from the patient may also need to be transported to the lab. This involves careful planning and coordination between the various parties involved.
There are many challenges faced by companies managing cell and gene therapy supply chains:
- They require delivery within a specific time frame. This is needed to maintain their effectiveness.
- They need strict temperature control. It keeps them stable and potent during transport.
- They must meet strict regulatory rules. This is especially true when they are transported across borders.
- They are valuable and often irreplaceable. So, keeping a clear chain of custody is critical.
- Some cell and gene therapies require special handling. This includes using biohazard containers and avoiding certain types of transport.
The role of the cell and gene therapy supply chain
When planning cell and gene therapy logistics, steps must be taken to safeguard samples throughout the transport process. This ensures they are viable when they reach patients.
Cell and gene therapies need to stay cold during transit to avoid damage. This often requires cold-chain or cryogenic supply chain solutions with temperatures as low as -150℃. Failure to keep a reliable temperature can cause the sample to degrade. This can undermine the treatment’s effectiveness.
The right cryogenic packaging can help keep cell and gene therapies at a consistently low temperature throughout their journey. Each cell therapy shipment will have many layers of packaging to protect the product and keep it stable:
- Primary packaging: Cryobags or cryovials containing the cell sample.
- Secondary packaging: Container or rack to secure primary packaging.
- Tertiary packaging: Liquid nitrogen (LN2) dry shipper.
- Outer packaging: A pallet or box to contain and secure the LN2 shipper.
Cold storage facilities may also be required if the full journey – from patient to lab, or from lab to patient – cannot be completed in a single step.
ICS’ cell and gene therapy logistics
Our services
With the patient in the supply chain, things become more complicated. Innovators need a coordinated cell and gene commercialization solution. It must scale up and support patients and providers equally. A manufacturer’s primary concern should be continual innovation, not infrastructure building to support gene therapy commercialization.
ICS offers integrated cell and gene therapy logistics, which include cryogenic storage, customer service, order-to-cash financial management, and various product distribution models. These can work together to reduce financial risk and operational burden.
Why ICS?
ICS provides innovative distribution services for specialty medications. These include cell and gene therapy logistics solutions, as well as support for branded and generic drugs, biosimilars, and medical devices.
Customers choose us for these key reasons:
Commitment to excellence
Expert account management model
Integrated commercialization solutions
Partnership-driven approach
Proven, innovative solutions
Proven performance
Cell and gene therapy FAQs
Cell and gene therapies have a 90% success rate during manufacturing – meaning nine in 10 doses are viable for patient use.
Around 650,000 patients are expected to be treated with cell and gene therapies over this decade. 325,000 of these are anticipated to be cancer patients.
The cell and gene therapy market is projected to reach a value of $27.95 billion by 2030, up from $11.21 billion in 2022.
The manufacturing process for a cell or gene therapy will depend on the type of therapy – autologous, allogeneic, or gene therapy.
Manufacturing an autologous therapy involves collecting a sample from a patient in a clinic, which is then transported to a manufacturer to be engineered into a therapeutic product. This will then be transported back to the clinic to be reintroduced to the patient for treatment. The final therapy is only administered to the patient who provided the sample.
Allogeneic cell therapy involves fewer transport steps. This is because it uses a single donor sample to engineer therapies for multiple patients. Gene therapies likewise involve fewer transit legs.
In all cases, it is essential to maintain cell viability throughout transport, by minimizing the risk of delays or changes in temperature.