White Paper

Innovative Strategies To Maintain Product Integrity In Biologic & Biosimilar Clinical Studies

Source: Catalent
Temperature

Understanding cold chain shipping challenges and comparing solutions for temperaturesensitive product handling

The number of biologic new molecular entities approved by the FDA has increased over the last five years indicates a growing focus on biosimilar and targeted therapies. In this highly competitive area of research, clinical studies have become more complex due to the use of strategies designed to accelerate development and ultimately gain market approval faster. These highly targeted studies generally compete for a smaller pool of potential patients, often on a global level, and increasingly are employing complex protocols such as adaptive designs which have a direct impact on the clinical supply needs.

Efficiently managing complex biologic/biosimilar studies requires a keen understanding of the clinical supply challenges associated with handling these highly-sensitive products and developing a solid plan to mitigate the risk potential delays and safeguard product integrity. While some setbacks in a clinical trial are unexpected and can occur with even the best of planning, there are proactive steps sponsors can take to better manage supply chain performance. This paper discusses the potential impact of clinical supply disruptions, presents several strategies and options for cold shipper technologies to maintain product integrity during transit.

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