The customer, a global biopharmaceutical company with a global total turnover of > 10 billion USD, produces more than eight different bulk drug substances (BDS) in batch sizes from 100l to 1300l, with multiple batches per year, for late-phase and commercialized products. The BDS is filled into rigid containers (bottles) to -60°C (-76°F) and shipped within Europe or transatlantic with dry ice and stored at < -30°C (-22°F) for several months at its destination, the fill & finish site (F&F). At the F&F site, the BDS is thawed for producing the drug product.
Based on the selection of the primary packaging in the early clinical phase there are PETG bottles used with sizes from 1 to 5l. Due to the scale up and increased volumes about 1.000 to 25.000 bottles per product per year have to be filled, frozen and shipped.
The biggest problem for the customer was the growing expensive cold storage capacity due to the low storage density of bottles, based on their shapes and dimensions. Furthermore, walk-in cold rooms are expensive not only CAPEX wise, also OPEX wise due to utility costs and validation work including required backups.
Continue reading to learn how the customer moved to single-use bags protected by a flexible bag manufacturer independent and high storage density secondary packaging, which is designed for freezing applications to solve their problem.