Why freeze drying?
Better product stability
Freeze drying has long been used as a method for preserving food – the cold winds of the tundra provided the first known freeze drying process, enabling meat to be stored through the winter. Read more
The benefits of drying vaccines for longer term stability were recognised by Jenner and in the early 20th Century freeze drying was employed for the preparation of rabies virus. The method was subsequently used for the preparation of antibiotics in the 1930s and has been a valuable tool in the manufacture of a wide variety of drugs and active preparations, with particular benefits for the stabilisation of sensitive biological materials.
Reduction of weight and volume
Water is often the single greatest component of a drug formulation in terms of weight and volume. The cost of transporting and storing this water can be significant. Read more
Along with other advantages of freeze drying, removal of water can reduce the financial burden of shipping and storing unnecessarily bulky product both at the stage where the active ingredient is produced and as a fully formulated drug.
Eliminate the need for cold chain distribution
Often drugs (and particularly vaccines and sensitive biologics) require cold distribution and storage, adding significantly to the cost and logistical complexity of supply. Read more
With the additional stability that freeze drying can bring to a product, these costs and problems can be avoided.
Formulation of a freeze dried product can change the solubility, cosmetic appearance and other physical attributes of a product, characteristics which can be adjusted by careful formulation prior to freeze drying. Read more
Such manipulation can make a drug formulation more amenable to distribution in, for example, tablet form or in sachets, ampoules, capsules, blister packs and aerosolised/inhaled products.
Working with Clarity
We understand the importance of research
A full understanding of the freeze-drying behaviour through research will enable optimisation of process for maximum retention of activity and cost effectiveness for large scale production. Read more
A firm understanding of the requirements of the final product will inform early stage R&D studies to ensure the final formulation meets product stability criteria and suitability to produce in the desired format (e.g. tablet, powder, aerosol delivery, sterile vial, etc.). This ‘bottom up’ approach can save time and money reformulating a product later down the development pathway.
We are an experienced team
The Clarity team have extensive experience in the process of drug development from research and development through to cGMP manufacturing. Read more
We understand the complexities of the research process and the particular sensitivities and nuances that come with working with biologics, viruses and live organisms. Our experience extends beyond the freeze drying process itself and we aim to deliver an integrated service in which we effectively become a part of the R&D process to anticipate and avoid problems during both the research and production phases.
We take a holistic view of the drug development process
The research and development programme we undertake in partnership with our clients aims to deliver not just a freeze drying solution in isolation. Read more
We work with clients to look at the ‘big picture’ and anticipate the requirements of the freeze-drying process in terms of cost, manufacturing, regulatory requirements and product requirements, adding value to the research and development we carry out.
Our service/how we work
We begin with an appraisal of the product – its nature, sensitivities and the ultimate requirements of the fully formulated drug. Read more
A full evaluation of the current knowledge of freeze drying research relating to the product will be carried out to inform a process of rational formulation development. A variety of test formulations can then be assessed, initially to determine the behaviour of the material under freeze drying (sensitivity to freezing, determination of critical physical characteristics such as glass transition temperature, etc.) before carrying out drying trials. Once the correct formulation has been identified, further trials will be carried out to optimise the drying cycle to ensure maximum product stability with minimum (and therefore most cost-effective) drying time.
We are experienced R&D scientists and, where practical, we can offer services beyond freeze drying and would be willing to consider extending services as required and where we have the required skills. Read more
Such areas might include assay development, quality issues, regulatory guidance, etc.