Can Bulk Freeze drying be Successfully Adopted into Pharmaceutical R&D?

Bulk freeze drying has common applications across the food industry for instant coffee, fresh fruits, and dairy products such as milk, but has also proved an extremely useful technique in the pharmaceutical industry for drying a variety of materials from fermentation of bacterial samples, to small molecules, large amounts of active pharmaceutical ingredients (APIs) during early stage research and development, and as manufacturing process intermediates.

Bulk freeze drying is governed by similar mass transfer mechanisms found in traditional glass vial systems but may demand closer attention to detail to ensure success due to the larger volume of liquid or solvent being removed per container and full formulation characterisation plus knowledge of the freeze dryer specifications is paramount especially during the scale up of any bulk drying process.

A major benefit of bulk drying over lyophilising in vials is that vials are generally arranged hexagonally across a freeze dryer shelf and, it has been argued that about 20-30% of the freeze dryer shelf is unused when employing this arrangement. Drying larger volumes of material in the bulk format benefits an operator by having a larger surface area available, allowing potentially higher productivity.

In conclusion, yes, bulk freeze drying is an extremely useful and popular method of drying a range of materials in the food, dairy, bio-tech, AND pharmaceutical industries, lending itself particularly well to the R&D stages. Despite some of the additional optimisation considerations of both the formulation and cycle recipe involved to make the process as efficient as possible, the benefits received from maximising shelf space and the use of basic containers help to make large volume freeze drying a less labour and cost intensive process, which is why it is becoming a more viable and attractive option for the pharmaceutical industry.

More information online: www.biopharma.co.uk