Streamlining Biotechnology Supply Chains

How CSI’s scientific insight delivered an agile sourcing model and substantial cost savings for a listed biotechnology company’s global trial

Challenge

One of our clients, a leading T Cell Receptor (TCR) biotechnology company, has several biological therapy products in development for a range of oncology and autoimmune indications. They also conduct first-in-class research into new treatments for infectious diseases utilising their pioneering immunotherapies.

The client approached CSI while running clinical trials in many different countries for an investigational product that is administered in conjunction with saline and human serum albumin (HSA). 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 ancillary products.

There are a wide variety of saline and HSA products available in the trial countries, each with different bag or container materials. Since there was limited stability data regarding the equivalency of local products, the client initially had to source all saline and HSA centrally. This had a significant impact on costs and logistical complexity. While saline and HSA bags or containers are inexpensive, they are bulky and heavy products, so a central sourcing model increases overhead costs and adds complications and potential delays to the supply chain. In this case, the saline and HSA had to be relabelled to reflect the language of each trial country, which added yet more expense and complexity to the undertaking.

Solution

CSI provided scientific insight regarding the different types of bag or container materials that are marketed and used to carry saline and HSA, as well as the different strengths of HSA available across the large number of countries in the trial, including:

• Australia

• Canada

• France

• Germany

• New Zealand

• Russia

• Ukraine

• United Kingdom

• United States

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 sourced 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 the compatibility of their investigational product with each type of container material and the different strengths of HSA.

Result

After confirming the compatibility of their investigational product with the different saline and HSA bag or container products, our client migrated to a local site sourcing model for the saline and HSA used in their trial.

This averted the need to centrally source and distribute these heavy items, creating a much simpler, more 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 its 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!" – Director of Drug Product, Formulation & Stability at a leading gene therapy Biotechnology company

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