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Maintaining Product Integrity In Biologic & Biosimilar Clinical Studies

Summary: Specialized expertise in cold chain shipping and logistics are critical to avoid costly delays and potential for patient harm resulting from an interruption or delay in necessary clinical supply. Maintaining product integrity and reliability of supply can be especially challenging for biologic and biosimilar studies as the investigational and reference products will almost certainly require cold chain handling and may be high value, very limited in supply or require long lead times for new batches.

Clinical supply complexity increases for global studies that span a wide range of countries which may include those in cold northern latitudes to hot, humid tropical regions. Country specific import/export requirements, infrastructure and product security concerns, and variations in optimal packaging configurations and shipping lanes all have the potential to significantly impact study timing and must be carefully considered well in advance of the anticipated study start date.

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