Case Studies in Supply Chain Management: Getting it Right From the Start Part 2, Planning for Allogeneic Therapies
As discussed in my previous blog post, consistent management and communication are the keys to success when managing the supply chain of any advanced therapy clinical trial. It is important to remember that each part of the supply chain is equally critical and requires careful management and strategic planning.
When planning for allogeneic therapies, the supply chain management challenges are different than those for autologous therapies but equally impactful. There are several key factors that can reduce the risk and the cost within the supply chain. One key area for cost reduction is standardizing labeling procedures. By using standard labeling, such as barcodes, depots are able to reduce time and cost for sample pulls for distribution. This also aids in reducing variability and human error when QC checks are performed. Standardized processes also facilitates reduced cost by implementing efficient solutions for sample handling across multiple vendors.
In this case study, Fisher BioServices was working with a partner to manage the supply chain for an allogeneic drug that was going into a global phase III clinical trial. The challenge in this case was the cost of production and subsequently the cost of the entire global trial. Production costs for biologics, especially advanced therapies, can be quite high due to regulatory demands, material and facility cost, and the time associated with process scale-up. This particular sponsor had decided to manufacture lots of drug that would support multiple countries within the trial, requiring country-specific labeling and packaging be done at -120°C or the drug efficacy may be compromised (based on stability data).
Keeping in mind the need for efficiencies and the temperature specifications for product handling, the teams of engineers at Fisher BioServices partnered with the client as well as a medical device developer to create a semi-automated process for secondary packaging and labeling that can be executed at temperatures colder than -120°C to ensure product integrity. The device developed also helped to reduce the total packaging cost by reducing the labor time required to package material by 50%.
The solution ultimately enabled our client to use a single production lot to support clinical trials in 17 countries. Additionally, the packaging process was designed to be scalable for use in commercial distribution, which helps to reduce any further development costs after phase III.
As you can see from the case studies presented in this blog series, advanced therapies pose many unique challenges to the supply chain. The keys to overcoming these obstacles lie in careful planning and central management of the entire supply chain.
Are you currently involved in an advanced therapy clinical trial? If so, I’d like to share a case study we developed recently regarding how a company saw 55% cost savings across its distribution system, and increased visibility of its supply chain through meaningful data. Download your free copy of our case study Reducing Cost within Advanced Therapy Clinical Trials by selecting the icon below.