The Unique Needs of the Cell and Gene Therapy Supply Chain

As the cell and gene therapy industry emerges, new supply chain demands arise with it. Biopharma companies must optimize distribution partners and supporting infrastructure to ship biological material under tight deadlines and strict temperature controls. These therapies require advanced logistics solutions to deliver optimal efficiency and just-in-time doses to patients.  

Cell and gene therapies can provide reliable treatments for patients, making these therapies highly valuable and commercially profitable — if companies along the supply chain can overcome the challenges of distributing these materials effectively. With such complex logistical needs, companies require solutions for gaining visibility into and optimizing the gene and cell therapy supply chain. 

What Is Cell and Gene Therapy? 

Cell and gene therapy is a curative treatment that replaces a patient's mutated cells and genes with genetically engineered biological material to heal diseased cells. An estimated 350 million people worldwide suffer from genetic diseases that otherwise have no cure. Cell and gene therapy may be able to replace patients' damaged cells to provide a cure for their disease rather than modulating its course with other drugs and surgeries. 

Cell and gene therapies include various treatments, such as counteracting undesirable gene expressions with RNA, stimulating immune responses with DNA vaccines and replacing damaged cells with healthy ones through engineered immunotherapy. These therapies' relative novelty and personalized nature demand innovative solutions in the supply chain and distribution model. 

The Gene and Cell Therapy Supply Chain 

The cell and gene therapy delivery process is a complex system requiring high visibility and involvement from supply chain partners with specialized capabilities. The steps in the gene and cell therapy supply chain differ depending on whether the cell therapy is autologous or allogeneic. Both supply chains revolve around effectively providing treatments and associated care to the patient. 

Autologous Cell Therapies 

Autologous cell therapies involve extracting the patient's cells or genes to treat and prepare them for reentry into the body. The autologous gene therapy delivery process follows this cycle: 

1. Patient: The patient's cells or tissue are extracted. 
2. Distributor: The biological material is shipped via cold chain for analysis and treatment. The cells and tissue may be shipped at low temperatures or be cryopreserved. 
3. Manufacturer: Biopharma companies genetically modify and manufacture healthy cell and tissue products from the patient's biological material. 
4. Distributor: Manufacturers ship the modified cells and genes back to the patient's clinic. 
5. Authorized treatment center: Only authorized cell and gene therapy treatment centers may receive the therapies and administer them to the patient. 
6. Patient: The patient's treated cells or tissue are reintroduced using bedside infusion and begin replacing unhealthy cells. 

Allogeneic Cell Therapies 

Allogeneic cell and gene therapies use the healthy cells of a donor to modify them for patients. The supply chain for this type of therapy differs because of the origin of the cells used: 

1. Donor: A donor provides healthy cells or genes that can be modified for patients. 
2. Distributor: Freight partners ship the cells to the manufacturer at extremely cold, specific temperatures. 
3. Manufacturer: The manufacturer produces cell and gene products for multiple patients using the donor's biological material. 
4. Distributor: Distributors ship the products from the manufacturer to the authorized treatment center. 
5. Authorized treatment center: Treatment centers coordinate delivery with the distributor. 
6. Patient: Multiple patients receive cell therapies produced from the donor's cells. 

Challenges of the Gene Therapy Supply Chain 

Cell and gene therapies require specialty supply chain solutions beyond those used with traditional pharmaceutical products. Consider a few challenges of cell therapy transportation and how stakeholders can mitigate them: 

1. Quality Sensitivity 

Cell and gene therapies are highly sensitive. These small batches of cells have a short half-life before quality deteriorates, making it essential to use effective preservation methods and cold chain throughout the supply chain. 

The optimal shipping temperatures for cell and gene therapies are ultra-low, around negative 120 degrees Celsius for cryopreservation — or negative 184 degrees Fahrenheit — and at similarly low temperatures for dry ice, liquid nitrogen, and refrigeration preservation methods. Authorized treatment centers must also be able to properly store, handle, and thaw the drug products. 

Most current pharmaceutical supply chains are ill-equipped to handle these increased needs. Complete visibility into the supply chain is necessary, so logistics partners can plan for contingencies and optimize workflows. 

2. Process Tracking 

Cell and gene therapies require strict monitoring of the chain of identity (COI) and chain of custody (COC). COI tracking involves ensuring the drug products are traceable and identifiable throughout the treatment journey, beginning with the extraction of the raw materials through manufacturing and treatment. COC refers to stakeholder possession of the drug products at any point in the value chain. Enabling end-to-end process tracking is critical for ensuring product safety and quality. 

3. Real-Time Communication 

Communication is vital at every stage of the gene and cell therapy supply chain, especially in therapy delivery. Because of the time-sensitive nature of these therapies, authorized cell and gene therapy treatment centers must be equipped to receive drug products and deliver treatment to patients within a short period. Often, treatment centers are located in strategic areas to maximize patient concentration. However, some patients must cross state or national borders to access care.  

Upon delivery of the drug products, doctors must quickly communicate with patients about receiving their treatment. Treatment centers have to prepare patients before administering therapies at the bedside. 

4. Quality Monitoring 

Quality monitoring in gene therapy supply is crucial to production and distribution. Many factors can affect and indicate cell and drug product quality, including temperature, dwell time, color and sedimentation. These elements must be monitored at every step of the supply chain. 

The rise of smart technologies like the Internet of Things (IoT) allows stakeholders to access real-time shipment data. IoT sensors gather information about each shipment, including cell concentration, temperature, location, pressure, and color abnormality. Supply chain software also provides increased visibility so stakeholders can monitor product quality and safety. 

5. Time Pressure 

Cell and gene therapies use just-in-time manufacturing to increase production and delivery efficiency and prevent spoilage. From apheresis of the cells to treatment, the clock is ticking for every stakeholder to ensure process timeliness. 

The time pressure on these therapies places an increased demand on stakeholders to accurately forecast market demand, avoid excess production and mitigate potential delays. Shipments must be exact yet agile to deliver treatment to patients within a strict timeframe.  

6. Demand Planning 

Cell and gene therapies are relatively new and usually have high price points, making demand planning challenging. The availability and capabilities of authorized treatment centers can also affect demand, as these centers need the proper setting for storing, handling, and administering therapies. 

Scheduling is another vital aspect of the gene and cell therapy supply chain. Manufacturers, patients, and freight suppliers must coordinate at each step to ensure proper timing of cell extraction, shipping, manufacturing, and delivery. Scaling these operations requires advanced supply chain software capable of handling complex supply chain coordination. 

Increase Supply Chain Efficiency With ParkourSC 

Any stakeholder along the cell and gene therapy supply chain can benefit from gaining real-time insights into the value chain to make more informed decisions and improve process efficiency. Selecting a supply chain software that provides predictive insights enables biopharma companies to reduce risk, increase productivity and power growth. 

At ParkourSC, we empower companies to unlock greater value in their supply chains through our cloud-based supply chain operations platform. Our software provides real-time data to help mitigate supply chain risks for cold chain needs and increase visibility for all stages of the supply chain process, so partners can save money and improve decision-making. 

To learn more about our resilient supply chain solution for pharma manufacturing and life sciences companies, request a demo to see ParkourSC in action!