Case Studies in Supply Chain Management: Getting it Right From the Start Part 1, Planning for Autologous Therapies
Consistent management and communication are the keys to success when managing the supply chain of any advanced therapy clinical trial. In this two part blog series I’ll review two case studies that demonstrate the importance of supply chain management by focusing on scaling up for commercial distribution and on packaging challenges within a cryogenic environment.
This figure shows the distribution and logistics workflow for an autologous therapy from the point of cell collection through manufacturing, packaging, and distribution to the clinical site. This demonstrates the many activities that occur both before and after drug manufacturing, all of which are critical components, and require careful management and strategic planning.
Reducing Risk in the Supply Chain
Reducing the risk to the product can be done at almost every point in the supply chain. For example, validation of equipment to standard process parameters reduces the risk by ensuring the storage equipment meets all required specifications. Validation of shipping lanes reduces risk by ensuring that customs clearance procedures, documentation, and transport methods are verified so drug product does not get held or damaged. Overall, standardization of procedures (including collection, distribution, pack-out, and receiving/handling) can greatly reduce risk and variability in the process, which helps to reduce the total cost of the trial to the sponsor.
For autologous therapies, the challenges within the supply chain can be quite unique. Minimizing risk is absolutely critical for these therapies, as there is often only a single lot of drug product for a specific patient. These patient-specific therapies require unique labeling and packaging, which is often processed at the time an appointment is scheduled. This can drive up production costs, making efficiencies and control of these processes critical to managing cost. Additionally, the chain of custody is often more extensive for autologous therapies, as these are generated from a unique cell collection process.
Commercial Planning for Autologous Therapies
In our first case study, we’ll review the commercial planning for an autologous therapy currently in phase III clinical trials for patients with advanced renal cell carcinoma. The therapy is generated from a tumor collected from the patient, which is then transported to the manufacturing facility for processing into the final drug product. The drug product is then transferred at cryogenic temperatures to a storage depot, where it is packaged just-in-time for a clinical request. Challenges when planning for commercialization revolved around standardization of processes between vendors (for things such as labels, manifests, and handling techniques) and managing the just-in-time pack and label process for commercial distribution.
When planning phase III and commercial activity for this client several components were identified within their supply chain that could be optimized to help control both risk to the product and cost to the sponsor. The first step was to standardize collection kits used by the global collection centers. By standardizing the kit components and having them distributed from a central manufacturer (which in this case was Fisher BioServices), we were able to reduce simple errors in the collection process, receiving time at depots, CMOs, and clinical sites. This standardization was critical to this trial, and helped to ensure a consistent chain of custody from collection to manufacture of the therapeutic.
With regards to just-in-time secondary packaging, Fisher BioServices worked with the sponsor and the clinical sites to develop processes that worked with a current IVRS system. This helped to automate notifications of patient appointments, which allowed for faster, more efficient communication to the depots to begin packaging operations. Using validated shipping lanes assisted in determining the required transport time (depending on site location). The data gathered in these validation studies helped to drive operational processes to ensure that any shipments with a longer transport time were processed first; ensuring the patient dose is able to be given on schedule.
By working to standardize processes and communication between all partners involved in this study, we were able to optimize the efficiency of the supply chain. This helped not only to manage the overall cost of the trial logistics, but also helped to ensure that each patient received their treatment on time and at optimal efficacy.
Stay tuned for part 2 of this blog post where I will share another case study focused on supply chain planning for allogeneic therapies. In the meantime, If you're interested in learning more about cell therapy development strategies and the role of the cold chain, download our webinar Cell Therapy: Achieving Success on the Road to Commercialization.