Linkam Partner with BTL to Produce Solutions for the Pharmaceutical Industry

Market leaders in temperature controlled microscopy, Linkam Scientific Instruments, and freeze drying technology, Biopharma Technology Limited, celebrate ten years of partnership in supplying solutions to the pharmaceutical industry.

Biopharma Technology Limited (BTL) was founded in 1997 to develop freeze drying solutions to multiple materials in the world of pharmaceuticals. Freeze drying, also known as 'lyophilisation,' is a method of processing a liquid product into a dry solid product. The early days of the company saw homemade instrumentation based on ideas originating at Porton Down. However, in 2001, Director of Research at BTL, Dr Kevin Ward, came across Linkam and their range of temperature controlled stages. Freeze drying had often been a conducted in a hit and miss process without clear knowledge of the critical temperatures needed to produce the best product. The ability to provide accurate thermal characterisation right down to -196°C took the guesswork out of the process quickly and simply.

The two companies went on to develop a number of instruments, the latest being the Lyostat 3 freeze drying microscope. Dr Ward, understanding that a scientific approach was critical to the development of the process, has gone to perform contract work looking at more than 700 samples from companies worldwide. Being able to optimize the freeze drying temperature greatly aids the formulation in a vast family of biotech, pharmaceutical, diagnostic and agrochemical applications. The combination of BTL's applications knowledge and Linkam's instrumentation expertise brings a real added-value product to the freeze drying market place.

A typical experiment will look at the temperature at which a product undergoes collapse as this is the single most important characteristic for almost all freeze drying formulations. The Lyostat3 system uses polarized light microscopy to capture images of the sample's structural changes as temperature increases, information that is vital for successful freeze drying. This data is invaluable when developing a freeze drying cycle from scratch or in helping to identify the small adaptations in a freeze drying cycle that can transform the process operating costs. The advantages of a tailored production process are obvious; research has shown that a 1°C increase in product temperature can result in as much as a 13% increase in primary drying rate, demonstrating that thermal accuracy can transform process operating efficiency and costs.

The collaboration has also brought benefits to BTL through being able to provide quality pictures to illustrate the process at varying precisely controlled temperatures and pressures. For Linkam, it has been the benefit of being at the leading edge of an exciting and growing market. Freeze drying is growing. Whereas it used to be solely the domain of big pharma companies, it is now the smaller, specialty businesses in the fields such as biotherapeutics and biopharmaceutics that are using the BTL technology to study bigger, more complex molecules.

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