Written by Modality Solutions
Posted on: January 16, 2019
Immunotherapies are an increasingly complex set of treatments for a wide variety of diseases and medical conditions.
Two of the more exciting immunotherapies are ADCs (Antibody Drug Conjugates) and CAR-T therapy (Chimeric Antigen Receptor T cell). CAR-T therapies are further divided into autologous (patient specific) and allogeneic (genetically similar but not patient specific) therapies. An autologous CAR-T therapy has an especially complex supply chain, because each medical treatment is unique to each patient. This makes tracking and traceability of the cells a large risk in the treatment process.
Each of these treatments include added challenges in their supply chains that demand a solid engineering basis for validation. Modality Solutions offers novel technologies and expert engineers to help our clients face these challenges.
Our proprietary Hazard and Operability Study (HAZOP) technique is tailored for immunotherapy clients to ensure high risks are identified and mitigated properly.
In a recent HAZOP analysis, Modality Solutions uncovered that a number of hazards associated with timely product delivery, along with thermal conditions, posed the greatest risk for the shipping lanes of the cell cultures. Thermal conditions posed great risk because these components required storage at deep frozen temperatures during transport to facilities worldwide that perform the genetic reengineering of cells and efficiently return the cells to the right patient for treatment. Product delivery was critical because of the limited availability of material coupled with strict dosage requirements and gravity of the disease. Modality Solutions conducted a thermal test concurrently with shock and vibration challenges that would represent the worst-case scenario for the shipping lanes to determine if the selected packaging would protect the immunotherapy components in transit.
Our Advantage Transport Simulation Laboratory™ is able to simulate all major environmental hazards faced in shipping and distribution – shock, vibration, temperature, humidity, and pressure.
In another case study, the FDA requested our client to conduct detailed concurrent traceability and multi-hazard environmental testing on the precursors to the immunotherapy – the monoclonal antibody, linker, and cytotoxin. Using our Advantage Transport Simulation Laboratory, we exposed all products and respective packaging to simulated environmental conditions faced in the shipping lanes. This approach verified the quality of all three precursors after transport and ensured the capability of the packaging and components of the immunotherapy to withstand the environmental hazards faced before reaching the patient.
Modality Solutions also offers help with Validation Master Plans (VMP) and technical documentation as part of our supply chain services to ensure transparency and quality management in the supply chain.
For immunotherapy drugs, the facilities and transport elements of the VMP are crucial and often high risk. The fragility of the components for an immunotherapy solution and the temperatures they require for storage and transportation contribute to more difficult transportation and storage than other biopharmaceutical therapies. Navigating the immunotherapy supply chain is high-risk and challenging. Enlisting the help of professional supply chain services can alleviate some of the stress.
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