The client was running clinical trials with its investigational product in many different countries. The product is administered in conjunction with saline and Human Serum Albumin (HSA).
Written by: Vanessa Dekou
Time taken to read: 5 minutes
Our client is a leading T Cell Receptor (TCR) biotechnology company, with focus on delivering first-in-class biological therapies that have the potential to transform the lives of those with serious diseases. They have several products in development for a range of oncology, and autoimmune indications as well as research into new treatments for infectious diseases utilising their pioneering immunotherapies.
There is a wide variety of saline and Human Serum Albumin (HSA) products available in the trial countries with different bag/container materials. There was limited stability data regarding equivalency of local products.
As such, the client had to source all saline and HSA centrally. This had the effect of significantly increasing costs and logistical complexity. Saline and Human Serum Albumin (HSA) bags are inexpensive but bulky and heavy products and as a result, central sourcing increased the number of shipments and added complexity to the supply chain. The saline and HSA had to be relabelled with the trial country language adding yet more cost and complexity.
CSI was approached to evaluate and provide evidence so that our client could move from a central model to a local sourcing model for these products.
CSI provided scientific insight on the different types of bag material marketed and used for saline and HSA and the different HSA strengths available across the large number of countries in the trial including;
The range of products was diverse and included rigid containers and flexible bags. Made from a variety of materials including polyethylene (PE), polypropylene (PP), PE/PP copolymers and blends and polyvinylchloride (PVC).
CSI provided quantities of these products in different pack sizes and from different countries, covering the full range of materials used. Our client then carried out analytical testing to confirm compatibility of their investigational product with each type of container material and the different HSA strengths.
After confirming compatibility of product with the different saline and HSA products, our client migrated to a site-sourcing model for the saline and HSA used in their trial.
This removed the need to centrally source and distribute these heavy items, creating a much simpler, efficient,agile and cost-effective supply chain. In addition, the core product became easier to use and more attractive since no specific ancillaries were required for the administration. This resulted in very significant savings for the duration of the study.
‘It has been very beneficial working with the CSI team. They have excellent scientific expertise, clearly understood the challenge, and provided outstanding solutions. Their global reach allowed us to tap into many markets. They are customer focused, result driven and we enjoyed working with them. Well done Team!
Shahid Uddin, Director of Drug Product, Formulation and Stability.
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