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Single-Use Bags Offer Durability in Bulk Cold Chain Shipping

The containers are designed to remain durable after freezing at -86°C for global shipping of biopharmaceutical intermediates.

Before many temperature-controlled biopharmaceuticals become finished goods, their intermediate-stage bulk drug substances are shipped around the globe. Future Market Insights reports that demand for biologics is set to outpace the overall pharmaceutical industry’s growth, and global clinical trials add to the demand for robust temperature-controlled packaging.

 

But cold shipping presents a challenge to pharmaceutical manufacturers. “At temperatures of -80°C, single-use bags can be fragile and materials can crack. With such high-value bulk drug substances, this can cause waste in terms of materials and resources,” says Joe Cintavey, Product Manager at Gore PharmBIO Products, a division of W. L. Gore & Associates, Inc.

 

Beyond product loss, bag breakage with potent drugs like cytotoxics presents an additional challenge. Drug substances continue to increase in potency. If a leak occurs, are there systems in place for cleaning both the substance and the surrounding packages in a shipment? Are personnel aware of procedures that minimize their exposure?

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