Last week, revised guidelines for the Good Distribution Practices (GDP) of Medicinal Products came into force in the European Union, stipulating a number of new changes that ensure the temperature conditions are met in the storage and transportation of biologics.
Specifically to address these changes, packaging company Sonoco Thermosafe has launched its Aeris Series of pre-qualified shippers, “designed to hold medicines at temperatures between 2°C and 8° C when shipped specifically in Europe’s climate,” said spokesperson Sarah Anderson.
She told Biopharma-Reporter.com: “The majority of biologics are temperature sensitive - [requiring cold temperatures but cannot freeze] - and must be stored and shipped within a specific temperature range, otherwise, they can lose their efficacy.”
The new guidelines state, she continued, that “if there’s a claim on a medicine’s label on how the product should be stored, it must also ship under those conditions.” The Aeris Series maintains “the label’s storage temperature during shipment of the product for a minimum of two days, regardless of the season.”
The guidelines, drafted in 2011, were deemed necessary improvements on original European procedures published in the 1990s, with section 9.4 saying for temperature-sensitive products, such as biologics and vaccines, “qualified equipment should be used to ensure correct transport conditions are maintained between the manufacturer, wholesale distributor and customer.”
The product has only been available a week but Anderson described it response from the biopharma industry, as “tremendous.”
She continued: “We envision enormous success with this product line along with the numerous planned future configurations such as controlled room temperature (CRT), frozen, and longer durations that will follow.”