Freeze Dried Efficiency. How an intelligent choice of excipients can optimize your lyophilisation process

Optimizing the freeze drying process is an excellent way for pharmaceutical companies to increase efficiency, reduce costs and avoid product rejects.  However, every new formulation has its own critical temperature and therefore requires a unique drying process for optimum results.

K. Scoffin

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Headspace Moisture Mapping and the Information That Can Be Gained about Freeze-Dried Materials and Processes

Regulatory authorities require proof that lyophilization (freeze drying) cycles have been developed logically and demonstrate uniformity. One measure of uniformity can be consistency of residual water content throughout a batch.

I.Cook, K.Ward

Published in PDA Journal of Pharmaceutical Science & Technology, Sept/Oct 2011

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The production of lyophilised medicinal products raises many challenges, including identifying critical temperatures, ensuring that the product is processed accordingly, optimising cycles to reduce run times and manufacturing costs, making sure the right containers are used and fit for purpose, and ensuring product uniformity, activity and stability.

I.Cook

Published in Pharmaceutical Technology Europe, July 2011

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Applications of Headspace Moisture Analysis for Investigating the Water Dynamics within a Sealed Vial Containing Freeze Dried Material

Published in PDA J Pharm Sci Technol January/February 2011

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PDA J Pharm Sci Technol January/February 2011 65:2-11

The Long Term Storage of Red Blood Cells by Freeze Drying

Medical advances have increased demand for blood and blood products. But currently preservation technologies involve high costs of cold chain management. Furthermore, the shelf life of red blood cells preserved by refrigeration is just 35-42 days. The long term storage of red blood cells by freeze drying would provide many advantages, but there are many challenges to overcome to preserve structure and function.

K. Ward, T.Peacock, I.Cook, A. Lynch, N. Slater

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Freeze drying conditions can significantly affect the ultimate lyophile stability, dryness, morphology, porosity and surface area of proteins. An increase in moisture content or temperature may cause a glass transition and crystallisation of the sugar, resulting in a loss of thermal stability of the protein. For this reason knowledge of physico-chemical properties such as glass transition and water sorption behaviour is important.

D. Burnett, F. Thielmann, K. Ward, I. Cook

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Following the receipt of a grant from the UK Technology Strategy Board (TSB), BTL worked in conjunction with the University of Cambridge and biotechnology specialists Microbial Developments Ltd on a study to investigate methods of improving the delivery of probiotic bacteria.

The project focused on three key areas: optimisation of fermentation methods; freeze-drying formulation and procedure; and a gut delivery system. The aim was to produce stable Lactobacillus crispatus in a format that can be reliably and efficiently delivered to the gut.

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Moisture analysis is a fundamental aspect of the complete freeze-drying process to ensure the system is efficient and performing as it should. Consequently, moisture analysis is performed in both product and process development, as well as in manufacturing to specify and control the maximum allowable moisture content.

Replacing the slow traditional methods, such as Karl Fischer titration (KF) and thermo-gravimetric analysis (TGA) with a rapid, non-destructive method would streamline moisture analysis efforts and help improve the quality of the finished product.

>>Read More (Manufacturing Chemist)

In contrast with other known Atmospheric Spray Freeze Drying technologies, this new technology combines spray freezing, deposition / collection, and convective flow drying into one step employing co-current gas flow to spray-freeze the solution, convey the frozen powder toward an exit filter and in situ drying. This overcomes the difficulty of fluidizing a elutriating a cohesive frozen powder from a substrate.

T.D. Robinson, M.B. Weiss, I.Cook, T.Peacock, K.Ward

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The Use of Microscopy, Thermal Analysis, and Impedance Measurements to Establish Critical Formulation Parameters for Freeze-Drying Cycle Development

Published in Freeze Drying/Lyophilization of Pharmaceutical and Biological Products, Third Edition

K R Ward, P Matejtschuk

>>Read More: (Informa Healthcare)