Many biochemical and pharmaceutical companies already use or are familiar with the theoretical advantages of stabilising their products by freeze-drying. In comparison to those products stored at low temperature in solution, products stabilised by freeze-drying can have good long-term stability at much higher temperatures. For many of their compounds, the results do not live up to expectations with the dried product having poor long-term stability. This is usually because their product formulation and drying conditions have been selected on a trial and error basis, often with little understanding of what freeze-drying can achieve. At HATS, we can change all this by calculating the optimised conditions for your products.

 We use our in-house skills and specialised facilities to maximise the stability of your product by determining its optimum freeze-drying cycle. This is achieved by calculating primary and secondary drying times for your specific product, with its designated vial size and fill volume. We will determine, for you, the best conditions that will give a robust product with long-term stability every time.

 We determine the conditions necessary to make your product into a stable biological glass. This optimised freeze-drying process traps labile substances in a glassy matrix, thereby preventing inter-molecular interaction that normally results in product degradation. We do this using differential scanning calorimetry (DSC) to determine the glass transition temperature of your product. The optimised cycle is then calculated taking into account the glass transition temperature (g), the saturated vapour pressure (SVP) at the drying temperature, the rate of sublimation of water at that temperature, the vial geometry and the fill volume. From these calculations we determine the optimum freeze-drying cycle, to include both primary and secondary drying times. This information is then utilised to deliver the highest possible product stability combined with the most effective freeze-drying cycle. Finally, we verify that our advised conditions do work on your product by carrying out pilot freeze-drying cycles in our own freeze-dryer.

As consultants in freeze-drying HATS recognises the various requirements and resources of our clients and can, therefore, offer a comprehensive service in freeze-drying, tailored to our customers needs.

Clients come to us for the optimisation of existing products that can not be subjected to any formulation change. In this instance, we can promptly determine for them how the maximum stability of their product range can be achieved. With this relatively inexpensive exercise, we have shown our clients that room-temperature stability can be achieved on products that have previously required low temperature storage.

If you have any queries relating to freeze-drying or require access to our specialist facilities, please contact us either by e-mail, fax or telephone.

In order to provide the widest possible service to our clients and to assist them in the freeze-drying of their own samples, we work closely with experts in related fields. For example, manufacturers of specialist and research freeze-dryers and companies who can offer contract freeze-drying facilities.