Aseptic spray drying versus lyophilisation

Lyophilisation is currently the leading method in pharmaceutical manufacturing of small molecules and biologicals such as peptides, protein and monoclonal antibodies. But the next 5 years will be an exciting time for aseptic spray drying as a viable alternative to lyophilization - it's easier, faster, cheaper and a much gentler method of drying.

Although spray drying has been used by the pharmaceutical industry for some time — especially in API manufacture — until recently it has been unavailable for manufacturing injectable-grade products, such as vaccines, under truly aseptic conditions. Five years ago, wholly aseptic spray drying was in the theoretical and small-scale proof-of-concept stages; now it is commercially available and is gaining popularity, because of numerous advantages compared with other production methods. I believe this will become a first line option for many pharmaceutical companies — not to replace lyophilisation completely, but to have an equal share of the market.

Increasingly, companies are seeking alternative processes to lyophilisation to reduce costs and other associated problems. Many of them find that spray drying carries a number of advantages.

Efficiency Gains

Spray drying is flexible, efficient, and requires less financial investment and operational time compared with a similar scale lyophilisation plant. When spray drying is subject to high throughput, costs are significantly reduced because it is a continuous process that allows high-volume manufacturing, which is particularly important in the event of an epidemic, for example. Conversely, lyophilisation is a batch process and so the quantity of manufactured product is limited to the size of the lyophiliser.

Currently it is possible to aseptically spray dry products for up to 5 days continuously, manufacturing large, kilogram quantities of powder. Spray-dried powder can then be aseptically filled into vials, medical devices or capsules as a final presentation, all under the same roof. Efficiencies can also be gained using spray drying by co-processing APIs with other components such as solubility enhancers or stabilizers, which may not possible with lyophilisation.

Furthermore, lyophilisation cycles generally require a number of days, or sometimes weeks, to complete. An equivalent quantity can be manufactured using spray drying within a shorter period — because of high-volume capacity — and with less energy consumption.

Product Quality Benefits

Spray drying also contributes to a higher standard of manufactured product. Lyophilisation subjects materials to freezing temperatures, which can lead to damage. During spray drying, sensitive ‘actives’ within the product are not exposed to extreme temperatures for prolonged periods, which ensures they stay in the desired condition.

In addition, through particle engineering, spray drying enables powder improvement or manipulation to give greater physical characteristics, such as better dissolution or greater flowability. Reconstituting a lyophilized product is not as easy and can be problematic for the end user.

Personal experience has indicated that the future growth trajectory of this technology is significant. Nova has already had three major programmes through its facility, which are continuing contracts, and we’ve seen the level of new enquiries rise year on year. The pharmaceutical sector’s renewed interest in spray drying is because it is an enabling technology. Its ability to produce aseptic-grade materials makes it particularly attractive to the industry.

At Nova, we have combined aseptic spray drying with our stabilization platform VitRIS (Vitrified Readily Injectable Suspension) and Aerosphere Technology. A VitRIS product results in a room temperature stable, ready-to-inject pharmaceutical, and removes the need for refrigeration of products. Aerosphere Technology allows us to manufacture instantly dissolving, temperature-stable powder. The advances made in aseptic spray drying have benefited these technologies, which are also attracting significant interest. Aseptic spray drying is not just an alternative to lyophilsation; for some products it is the only option.

For more information

Sam de Costa

Stabilisation Project Manager

Nova Laboratories

Tel. +44 116 223 0100

[email protected]


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